Stool Consistency Score Research Articles

A Randomized Single Blind Parallel Group Study Comparing Monoherbal Formulation Containing Holarrhena Antidysenterica Extract with Mesalamine in Chronic Ulcerative Colitis Patients.

Background:Incidences of side effects and relapses are very common in chronic ulcerative colitis patients after termination of the treatment.Aims and Objectives:This study aims to compare the treatment with monoherbal formulation of Holarrhena antidysenterica with Mesalamine in chronic ulcerative colitis patients with special emphasis to side effects and relapse.Settings and Design:Patients were enrolled from an Ayurveda Hospital and a private Hospital, Gujarat. The study was randomized, parallel group and single blind design.Materials and Methods:The protocol was approved by Institutional Human Research Ethics Committee of Anand Pharmacy College on 23rd Jan 2013. Three groups (n = 10) were treated with drug Mesalamine (Group I), monoherbal tablet (Group II) and combination of both (Group III) respectively. Baseline characteristics, factors affecting quality of life, chronicity of disease, signs and symptoms, body weight and laboratory investigations were recorded. Side effects and complications developed, if any were recorded during and after the study.Statistical Analysis Used:Results were expressed as mean ± SEM. Data was statistically evaluated using t-test, Wilcoxon test, Mann Whitney U test, Kruskal Wallis test and ANOVA, wherever applicable, using GraphPad Prism 6.Results:All the groups responded positively to the treatments. All the patients were positive for occult blood in stool which reversed significantly after treatment along with rise in hemoglobin. Patients treated with herbal tablets alone showed maximal reduction in abdominal pain, diarrhea, and bowel frequency and stool consistency scores than Mesalamine treated patients. Treatment with herbal tablet alone and in combination with Mesalamine significantly reduced the stool infection. Patients treated with herbal drug alone and in combination did not report any side effects, relapse or complications while 50% patients treated with Mesalamine exhibited the relapse with diarrhea and flatulence after drug withdrawal.Conclusion:Thus, monoherbal formulation alone and with Mesalamine was efficacious than Mesalamine alone in UC.

Implantable Colonic Electrical Stimulation Improves Gastrointestinal Transit and Defecation in a Canine Constipation Model.

Colonic electrical stimulation (CES) may have a therapeutic potential for slow transit constipation (STC). This study aimed to evaluate the effects of implantable CES on gastrointestinal transit and defecation, and explore its mechanisms in a canine STC model. Two pairs of electrodes were implanted in each of the proximal colon and rectosigmoid junction (RSJ). Parameters were individualized according to the symptoms of the stimulated dogs. In the STC model, gastrointestinal transit and defecation were assessed to evaluate the effects of double-site CES, and of double-site CES combined with atropine or N-nitro-L-arginine (L-NNA) in a crossover design. Individualized parameters varied among the animals. The CES significantly shortened gastrointestinal transit time (GITT) and colonic transit time (CTT) compared with sham CES (p = 0.001 and p < 0.001, respectively). Compared with sham CES, the CES also exhibited significantly higher stool frequency and stool consistency score (p = 0.018 and p = 0.001, respectively). Co-treatment with atropine or L-NNA blocked the effects of CES on GITT, CTT, and stool consistency. The stool frequency increased by CES, however, only reduced by co-treatment with L-NNA. This double-site implantable CES can improve the gastrointestinal transit and defecation in a canine STC model, possibly by activating the cholinergic and nitrergic pathways. The CES mode used in this study may be proven feasible in treating STC.

The Efficacy of Lubiprostone Is Not Affected by Body Mass Index in Patients With Chronic Idiopathic Constipation

Introduction: Lubiprostone, a ClC-2 chloride channel activator, is effective for the treatment of chronic idiopathic constipation (CIC) in adults. We aimed to determine the effect of body mass index (BMI) on the efficacy of lubiprostone treatment (24 mcg twice daily) in a post hoc analysis of two phase 3 studies of CIC. Methods: Data were pooled from two 4-week, randomized, double-blind, placebo-controlled studies in patients with CIC and were stratified based on BMI < 25 kg/m2 vs ≥25 kg/m2. A weekly responder was a patient who had ≥3 spontaneous bowel movements (SBMs) and an increase of ≥1 SBM over baseline during a given week; an overall responder met the weekly responder criteria for all 4 weeks. Additionally, stool frequency (SBMs/week), patients' ratings of stool consistency (0-4; 0=very loose to 4=very hard), and degree of straining (0-4; 0=absent to 4=very severe) were compared. Results: 239 patients treated with lubiprostone (BMI < 25, n=107; BMI ≥25, n=132) and 240 patients who received placebo (BMI < 25, n=114; BMI ≥25, n=126) were included in the analysis. Baseline efficacy parameters were generally similar for patients who received lubiprostone or placebo. The percentage of weekly responders to lubiprostone treatment was not statistically different between those with a BMI < 25 (range, 64.6%-78.8%) or BMI ≥25 (range, 67.7%-79.5%); overall responder percentage was similar for patients with BMI < 25 (43.9%) and BMI ≥25 (53.0%). Stool consistency scores were also similar, with mean scores ranging from 1.83-1.93 and 1.72-1.81 in patients with BMI < 25 and SMBI ≥25, respectively. Except for week 1, no significant differences by BMI were observed in the mean number of SBMs/week or the degree of straining. Except for week 3, the percentage of treatment responders was statistically significantly higher (P≤0.0231) in patients treated with lubiprostone compared with those receiving placebo, regardless of BMI. Additionally, the weekly number of SBMs was significantly higher(P≤0.0012) and stool consistency (P<0.0001) and straining scores (P≤0.0027) were significantly lower in patients treated with lubiprostone compared with placebo, regardless of BMI category. An analysis excluding male patients provided similar results. Conclusion: BMI status does not appear to affect the efficacy of lubiprostone in the treatment of CIC, and patients improved irrespective of their BMI status.

Stool consistency is strongly associated with gut microbiota richness and composition, enterotypes and bacterial growth rates

ObjectiveThe assessment of potentially confounding factors affecting colon microbiota composition is essential to the identification of robust microbiome based disease markers. Here, we investigate the link between gut microbiota variation...

Sex Differences in Experimentally Induced Colitis in Mice: a Role for Estrogens.

Sex differences have been found in the incidence and progression of inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn's disease. The reported differences in observational studies are controversial, and the effects of sex hormones on the pathogenesis of IBD are not clear. The aim of this study was to analyze sex differences in the progression of experimentally induced colitis. Experimental colitis was induced in adult mice by adding 2% dextran sodium sulfate (DSS) into drinking water. Male and female mice were used as intact, gonadectomized, and supplemented with either estradiol or testosterone. In comparison to males, female mice with induced colitis had significantly longer colon (p < 0.05), lower decrease in body weight (p < 0.001), and lower stool consistency score (p < 0.05). Histopathological analysis showed less inflammatory infiltrates (p < 0.001) and crypt damage (p < 0.001) in female mice. Female mice with colitis had also lower concentration of TNF-α in colon homogenates (p < 0.01). Supplementation with estradiol in ovariectomized mice ameliorated the severity of colitis. Female mice are partially protected against chemically induced colitis. This protection seems to be mediated by estradiol.

The impact of primary and persistent cytomegalovirus infection on the progression of acute colitis in a murine model

Cytomegalovirus (CMV) infects 60–100% of the population worldwide. CMV has been implicated in many diseases through the induction of inflammation. Inflammatory bowel disease (IBD) affects over 1 million Americans annually. IBD, in particular ulcerative colitis, has been associated with CMV infection. Here we use a murine model to test if both primary and persistent CMV infections exacerbate colitis. C57Bl/6J mice were injected with Mock inoculum or murine CMV (mCMV) 4d (primary infection) or 6wks (persistent infection) before inducing colitis. Colitis was induced by administering 3% DSS (dextran sodium sulfate) in the drinking water for 6 days. Distilled water was given to controls. Disease activity index (DAI), derived from scores for stool consistency, body weight loss, occult blood, and rectal bleeding, was recorded daily. DAI increased early with DSS treatment in Mocks when compared with water-treated controls. This was accelerated by both primary and persistent mCMV and appeared to be primarily due to the earlier appearance of gross bleeding vs. their Mock controls. Mocks reached similar DAI values by day 6. Myeloperoxidase was modestly elevated in the mCMV 4d-DSS over the Mock 4d-DSS, however there was no such synergism in the 6wk groups. Histology was comparable in Mock and mCMV groups. Taken together our findings show that mCMV accelerated the development of acute colitis although a milder model of colitis may be needed to better delineate the impact of the virus on disease progression. Further work focusing on disruption of barrier function and bleeding may help determine the underlying mechanisms.

Stool fatty acid soaps, stool consistency and gastrointestinal tolerance in term infants fed infant formulas containing high sn-2 palmitate with or without oligofructose: a double-blind, randomized clinical trial.

BackgroundFormula-fed (FF) infants often have harder stools and higher stool concentrations of fatty acid soaps compared to breastfed infants. Feeding high sn-2 palmitate or the prebiotic oligofructose (OF) may soften stools, reduce stool soaps, and decrease fecal calcium loss.MethodsWe investigated the effect of high sn-2 palmitate alone and in combination with OF on stool palmitate soap, total soap and calcium concentrations, stool consistency, gastrointestinal (GI) tolerance, anthropometrics, and hydration in FF infants. This double-blind trial randomized 165 healthy term infants 25–45 days old to receive Control formula (n = 54), formula containing high sn-2 palmitate (sn-2; n = 56), or formula containing high sn-2 palmitate plus 3 g/L OF (sn-2+OF; n = 55). A non-randomized human milk (HM)-fed group was also included (n = 55). The primary endpoint, stool composition, was determined after 28 days of feeding, and was assessed using ANOVA accompanied by pairwise comparisons. Stool consistency, GI tolerance and hydration were assessed at baseline, day 14 (GI tolerance only) and day 28.ResultsInfants fed sn-2 had lower stool palmitate soaps compared to Control (P =0.0028); while those fed sn-2+OF had reduced stool palmitate soaps compared to both Control and sn-2 (both P <0.0001). Stool total soaps and calcium were lower in the sn-2+OF group than either Control (P <0.0001) or sn-2 (P <0.0001). The HM-fed group had lower stool palmitate soaps, total soaps and calcium (P <0.0001 for each comparison) than all FF groups. The stool consistency score of the sn-2+OF group was lower than Control and sn-2 (P <0.0001), but higher than the HM-fed group (P <0.0001). GI tolerance was similar and anthropometric z-scores were <0.2 SD from the WHO growth standards in all groups, while urinary hydration markers were within normal range for all FF infants.ConclusionsIncreasing sn-2 palmitate in infant formula reduces stool palmitate soaps. A combination of high sn-2 palmitate and OF reduces stool palmitate soaps, total soaps and calcium, while promoting softer stools.Trial registrationThis study was registered on http://www.clinicaltrials.gov: number NCT02031003.Electronic supplementary materialThe online version of this article (doi:10.1186/1475-2891-13-105) contains supplementary material, which is available to authorized users.

Tolerance of formulas containing prebiotics in healthy, term infants.

The aim of the study was to compare infants' gastrointestinal tolerance of formulas supplemented with 2 different levels of galacto-oligosaccharides (GOS) versus a control formula (CF) or human milk. Healthy, full-term infants (n = 180) were enrolled in this 3-group controlled, double-blind, multicenter study, and a concurrently enrolled, nonrandomized human milk-fed group (HM) by 8 days of age. Infants were randomized to be fed formula supplemented with either 4 g (EF4) or 8 g (EF8) GOS/L or a CF until day of life (DOL) 119. Infants were to be seen at DOL 14, 35, 56, 84, and 119. Parents were to record detailed 24-hour information about intake, tolerance to feedings, and stool patterns and consistency each day from enrollment to DOL 35, and for 3 days before DOL 56, 84, and 119. Stool consistency was scored on a 5-point scale as watery (1), loose/mushy, soft, formed, or hard (5). The mean stool consistency score was higher in the CF group throughout the study (CF > EF8 and CF > HM for all study periods and CF > EF4 from DOL 15 to 35, P < 0.05). There was a significantly higher percentage of watery stools in the EF8 versus the CF group from study day 1 (SD 1) to DOL 14 (P < 0.05), but no differences between the groups in number of stools per day. The percentage of feedings with spit up and/or vomiting within 1 hour after feeding was significantly lower for HM versus EF8 and CF from SD 1 to DOL 14 (P < 0.05). In this clinical study, milk-based term infant formula (Similac Advance) with 4 g GOS/L was well-tolerated in terms of stool consistency and additional measures of gastrointestinal tolerance by newborn infants through the first 4 months of life.

PS-268 Stool Characteristics And Gastrointestinal Tolerance Of Chinese Infants Fed Term Formula Containing Increased Sn-2 Palmitate And Oligofructose: An Observational Study

Background and aims Formula containing increased sn- 2 palmitate with oligofructose ( sn- 2+OF) may improve stool consistency. We hypothesised that hard and watery stool incidence among infants fed α-lactalbumin-enriched formula with sn -2+OF would be ≤2.5% (upper limit of 80% CI Methods Healthy term infants ( n = 4 40) aged ~42 days were enrolled in this 48-day study on their current feeding regimens: formula-fed ( n = 1 42), HM-fed ( n = 1 43), or mixed-fed ( n = 1 55). Stool consistency was assessed at 4 visits using a 3-day diary with validated 5-point scale (1 = watery, 5 = hard). Gastrointestinal (GI) tolerance was assessed using a validated questionnaire (score range = 13–65; lower values indicate better tolerance). Results Incidence of hard stools across visits ranged from 0.7% [80% CI: 0.1–2.7] to 2.1% [0.8–4.6] for formula-fed infants, with incidence rates ≤0.8% in mixed-fed, and no hard stools reported in HM-fed groups. Incidence of watery stools ranged from 2.8% [1.2–5.4] to 5.0% [2.8–8.3] for formula-fed infants, which was lower than the incidence rates for mixed-fed (≤8.2%) and HM-fed (≤16.3%) groups. Stool consistency score (2 = runny, 3 = mushy soft) of formula-fed infants (2.9) was higher than HM-fed infants (2.4–2.5; p Conclusions Formula with sn -2+OF fed to Chinese infants results in soft stools and low incidence of hard and watery stools. Low GI tolerance scores indicate the formula is well tolerated.

Evaluation of Alosetron Using the New FDA Composite Endpoint Demonstrates Strong Treatment Effect in Females With Severe Irritable Bowel Syndrome With Diarrhea

Introduction: Prior to 2010, most clinical trials of drug treatments for irritable bowel syndrome (IBS) evaluated drug effect by a global measure of overall IBS condition (i.e., adequate relief) and grading of specific relevant symptoms (i.e., abdominal pain, bowel urgency, stool form). The new FDA recommended assessment uses composite or co-primary endpoints which quantify the sum of scores for abdominal pain (AP) and stool consistency (SC) for IBS with diarrhea (IBS-D). To determine if previously approved drugs are also effective by the new FDA standard, we evaluated data from two pivotal Phase III alosetron (ALO) trials [S3BA3001 and 3002 selecting only severe IBS-D patients (mean SC ≥3.5; mean AP ≥2.0; bowel urgency on ≥50% days and, if available, IBS-impaired activity on ≥25% days)] plus one post marketing (PM) double blind placebo controlled study (S3B30040) conducted in female patients who met appropriate Rome IBS criteria. The PM study entered only female patients with severe IBS-D. Methods: In all 3 trials, patients met baseline criteria for eligibility and were randomized to 12 weeks treatment with ALO 1.0 mg bid or placebo (PBO). Symptoms were self assessed daily and registered using a telephone reporting system to rate AP [1=none; 5=severe] and SC [1=very hard; 5=watery]. Data from the 3 trials were mined to select for analysis only patients having baseline criteria for severe IBS-D. A monthly responder showed advantage for ALO over PBO in the composite endpoint for ≥2 of 4 weeks. Comparison of responder results is based on Fisher’s exact test. Results: The table shows differences in responder rates (ALO minus PBO) for the new composite endpoint in both treatment groups in the 3 studies (**p≤0.005; *p≤0.05). Conclusion: Re-analysis of similar, high quality alosetron clinical trials using the FDA recommended composite endpoint demonstrated a robust positive treatment effect for alosetron, as was also shown (p≤0.05) in the same patients for the adequate relief endpoint. Both endpoints gave similar results and support a significant treatment effect with alosetron. Results are among the first to compare treatment effect between the older global and newer composite score endpoints. Disclosure - Dr. Camilleri - no relevant disclosures. Dr. Krause - no relevant disclosures. Dr. Deveze - Employee of Prometheus Laboratories Inc. Dr. Rao - Employee of Prometheus Laboratories Inc. Dr. Earnest - Consultant for Prometheus Laboratories Inc. This research was supported by an industry grant from The study was conducted by financial support from Prometheus Laboratories Inc.Table 1

Prevalence and effectiveness of laxative use among elderly residents in a regional hospital affiliated nursing home in hsinchu county.

Long-term care residents are susceptible to constipation and one-half to three quarter of older nursing home residents receive laxatives regularly. The purpose of this study was to evaluate the factors related to abnormal bowel function and explore the effectiveness of laxative treatment among the elderly residents of a nursing home. A total of 110 residents older than 65 years old was enrolled in this study. The following variables were gathered: age, gender, body mass index (BMI), length of stay, daily fluid intake, type of food, functional level, cognitive ability, physical therapy status, somatic and psychiatric diseases, number of medications, and medication use. The use and dosage of laxatives were recorded by means of Anatomical Therapeutic Chemical (ATC) classification system. Normal bowel function was defined as defecation frequency from three defecations per day to three defecations per week and stool consistency score of three to five on Bristol Stool Form Scale. A comparison between groups with normal and abnormal bowel function was drawn. Low BMI, increased fluid intake, liquid food intake, poor functional level, poor cognition, and a history of stroke were significantly associated with altered bowel function (P < 0.05). The most frequently used laxatives were glycerol, senna glycoside, and magnesium oxide. There were significant differences in laxative regimens between residents with normal and altered bowel function; those with altered bowel function tended to take more laxatives than those with normal bowel function. This study suggested that treatment of constipation in the nursing home was unsatisfactory. To improve treatment outcomes in those susceptible to altered bowel function, a coordinated approach with involvement of physicians, nursing staff, and other professionals including dieticians and pharmacists seems necessary.

Efficacy and Safety of Crofelemer for Noninfectious Diarrhea in HIV-Seropositive Individuals (ADVENT Trial): A Randomized, Double-Blind, Placebo-Controlled, Two-Stage Study

Background: HIV-associated diarrhea remains a significant concern with limited treatment options. Objective: To determine the optimal dose, efficacy, and safety of crofelemer for noninfectious diarrhea. Methods: This randomized, double-blind, phase 3 trial used a 2-stage design. Both stages included 2-week screening, 4-week placebo-controlled treatment, and 20-week placebo-free (open-label) extension phases. In stage I, 196 HIV-seropositive patients with chronic diarrhea were randomized to crofelemer 125 mg, 250 mg, or 500 mg or placebo twice daily. Using a prospective analysis, the 125-mg twice-daily dose was selected for stage II. In stage II, 180 new patients were randomized to crofelemer 125 mg twice daily or placebo for 4 weeks. Primary efficacy analysis was the percentage of patients (stages I/II combined) who achieved clinical response (defined as ≤2 watery stools/week during ≥2 of 4 weeks). During the placebo-free extension phase, response (≤2 watery stools) was assessed weekly. Results: Significantly more patients receiving crofelemer 125 mg achieved clinical response versus placebo (17.6% vs 8.0%; one-sided, P = .01). Crofelemer 125 mg resulted in a greater change from baseline in number of daily watery bowel movements (P = .04) and daily stool consistency score (P = .02) versus placebo. During the placebo-free extension phase, percentages of weekly responders ranged from 40% to 56% at weeks 11 to 24. Crofelemer was minimally absorbed, well tolerated, did not negatively impact clinical immune parameters, and had a safety profile comparable to placebo. Conclusions: In HIV-seropositive patients taking stable antiretroviral therapy, crofelemer provided significant improvement in diarrhea with a favorable safety profile.

Eluxadoline Benefits Patients With Irritable Bowel Syndrome With Diarrhea in a Phase 2 Study

Simultaneous agonism of the μ-opioid receptor and antagonism of the δ-opioid receptor can reduce abdominal pain and diarrhea in patients with irritable bowel syndrome with diarrhea (IBS-D) without constipating side effects. We evaluated the efficacy and safety of a minimally absorbed, μ-opioid receptor agonist and δ-opioid receptor antagonist (eluxadoline) in a phase 2 study in patients with IBS-D. We randomly assigned 807 patients to groups that received oral placebo twice daily or 5, 25, 100, or 200 mg oral eluxadoline for 12 weeks. The primary end point was clinical response at week 4, defined by a mean reduction in daily pain score from baseline of ≥ 30%, and of at least 2 points on 0-10 scale, as well as a stool consistency score of 3 or 4 on the Bristol Stool Scale (1-7) for at least 66% of daily diary entries during that week. Significantly more patients receiving 25 mg (12.0%) or 200 mg (13.8%) eluxadoline met the primary end point of clinical response than patients given placebo (5.7%; P < .05). Patients receiving eluxadoline at 100 mg and 200 mg also had greater improvements in bowel movement frequency and urgency, global symptoms, quality of life, and adequate relief assessments (P < .05). Additionally, patients receiving 100 mg (28.0%) or 200 mg (28.5%) eluxadoline were significantly more likely than those receiving placebo (13.8%; P < .005) to meet the US Food and Drug Administration response end point during the full 12 weeks of the study. Eluxadoline was well tolerated with a low incidence of constipation. In a phase 2 study of the mixed μ-opioid receptor agonist/δ-opioid receptor antagonist eluxadoline vs placebo in patients with IBS-D, patients given eluxadoline were significantly more likely to be clinical responders, based on a composite of improvement in abdominal pain and stool consistency. Further study of eluxadoline is warranted to assess its potential as a treatment for IBS-D.

Preventive effects of cranberry products on animal model of colitis

Patients with inflammatory bowel disease have a significantly higher risk for the development of colorectal cancer, however, treatments for inflammatory bowel diseases are limited and have severe adverse effects. Thus, there remains a critical need to identify effective bioactive components for the prevention of inflammatory bowel diseases. Importantly, there is potential that cranberries can be used to prevent inflammatory bowl diseases. By using a dextran sulfate sodium (DSS) induced colitis model, we tested the preventive efficacy of cranberries on colitis. 7‐week old male BALB/c mice were given treatment diets for 6 weeks; Negative control, control, positive control (5‐aminosalicylic acid), cranberry extracts (0.11 &amp; 0.011% total phenolics in diets), and dried whole cranberry (0.011% total phenolics with 0.7% cranberry fibers in diet). DSS was administered during week 3 and 6 to induce colitis. Hemoccult test, stool consistency scores, and colon length were measured. Cranberry extract (0.11% total phenolics) and dried whole cranberry fed groups showed significantly reduced hemoccult and stool consistency scores (20–52% and 34–66% reduction, respectively), where dried whole cranberry was more effective in preventing colitis over cranberry extract. Shortening of colon length, indicative of severity of colitis, was significantly prevented in animals fed dried whole cranberry compared to control. This suggests potential preventive effects of cranberry phenolics and especially fibers on development of colitis in this model. Supported by the Wisconsin Cranberry Board

Bacillus coagulans GBI-30, 6086 limits the recurrence of Clostridium difficile-Induced colitis following vancomycin withdrawal in mice

BackgroundRecently, we found that the probiotic strain Bacillus coagulans GBI-30, 6086 (GanedenBC30) improved indices of Clostridium difficile (C. difficile)-induced colitis in mice (Fitzpatrick et al., Gut Pathogens, 2011). Our goal was to determine if BC30 could also prevent the recurrence of C. difficile-induced colitis in mice, following initial treatment with vancomycin. During study days 0 through 5, mice were treated with antibiotics. On day 6, the C. difficile strain VPI 10463 was given by oro-gastric gavage at ≈ 5x104 CFU to induce colitis. Mice were treated on study days 6 to 10 with vancomycin (50 mg/kg) (vanco) or vehicle (saline) by gavage. On days 10 to16, mice were dosed by gavage with saline vehicle or BC30 (2 x 109 CFU per day). Mice were monitored for mortality, weight loss and diarrhea. On study days 14, 16 and 17, stools and colons were collected for analyzing other parameters of colitis.ResultsThe mean stool consistency score in Vehicle/C.difficile/Vanco mice increased from 0.4 (day 10) to a range of 1.1 to 1.4 (days 14 to 17), indicating the recurrence of colitis. On days 13 through 17, the stool consistency scores for the vancomycin/BC30 mice were significantly lower (p< 0.05) than for the vancomycin/vehicle cohort of animals. On day 17, 88.9% of mice treated with BC30 had normal stools, while this value was 0% with vehicle treatment (p value = 0.0004). Colonic myeloperoxidase (Units/2 cm colon) was significantly (p < 0.05) reduced from 4.3 ± 0.7 (Vehicle/C.difficile/Vanco) to 2.6 ± 0.2 (BC30/C. Difficle/Vanco). The colonic histology score and Keratinocyte derived-chemokine level in the colon were also lower in BC30 treated mice.SummaryIn BC30-treated mice, there was evidence of better stool consistency, as well as improved biochemical and histological indices of colitis, following initial treatment of animals with vancomycin.ConclusionBC30 limited the recurrence of CD-induced colitis following vancomycin withdrawal in mice.

Is Bifidobacterium breveeffective in the treatment of childhood constipation? Results from a pilot study

BackgroundProbiotics are increasingly used in the treatment of functional gastrointestinal disorders. Studies in constipated adults with a Bifidus yoghurt (containing Bifidobacterium breve, Bifidobacterium bifidum and Lactobacillus acidophilus) showed a significant increase in defecation frequency. The aim of this pilot study was to determine if Bifidobacterium breve is effective in the treatment of childhood constipation.MethodsChildren, 3 to 16 years of age, with functional constipation according to the Rome III criteria were eligible for this study. During 4 weeks, children received one sachet of powder daily, containing 108- 1010 CFU Bifidobacterium breve. Furthermore, children were instructed to try to defecate on the toilet for 5-10 minutes after each meal and to complete a standardized bowel diary daily. The primary outcome measure was change in defecation frequency. Secondary outcome measures were stool consistency using the Bristol stool scale frequency of episodes of faecal incontinence, pain during defecation, frequency of abdominal pain, frequency of adverse effects (nausea, diarrhoea and bad taste), and frequency of intake of bisacodyl.ResultsTwenty children (75% male, mean age 7.4) were included in this pilot study. The defecation frequency per week significantly increased from 0.9 (0-2) at baseline to 4.9 (0-21) in week 4 (p < 0.01). The mean stool consistency score increased from 2.6 (2-4) at baseline to 3.5 (1-6) in week 4 (p = 0.03). The number of faecal incontinence episodes per week significantly decreased from 9.0 (0-35) at baseline to 1.5 (0-7) in week 4 (p < 0.01). Abdominal pain episodes per week significantly decreased from 4.2 (0-7) at baseline to 1.9 (0-7) in week 4 (p = 0.01). No side effects occurred.ConclusionBifidobacterium breve is effective in increasing stool frequency in children with functional constipation. Furthermore it has a positive effect with respect to stool consistency, decreasing the number of faecal incontinence episodes and in diminishing abdominal pain. A randomized placebo controlled trial is required to confirm these data.

Randomised clinical trial: dried plums (prunes) vs. psyllium for constipation

Treatment of chronic constipation remains challenging with 50% of patients dissatisfied with current therapy. There is an unmet need for natural and safe alternatives. Dried plums (prunes) have been used traditionally for constipation but their efficacy is not known. Aim To assess and compare the effects of dried plums and psyllium in patients with chronic constipation. Subjects were enrolled in an 8-week, single-blind, randomised cross-over study. Subjects received either dried plums (50 g b.d., fibre=6 gm/day) or psyllium (11 g b.d., fibre=6 gm/day) for 3 weeks each, in a crossover trial with a 1-week washout period. Subjects maintained a daily symptom and stool diary. Assessments included number of complete spontaneous bowel movements per week, global relief of constipation, stool consistency, straining, tolerability and taste. Forty constipated subjects (m/f=3/37, mean age=38 years) participated. The number of complete spontaneous bowel movements per week (primary outcome measure) and stool consistency scores improved significantly (P<0.05) with dried plums when compared to psyllium. Straining and global constipation symptoms did not differ significantly between treatments (P=N.S.). Dried plums and psyllium were rated as equally palatable and both were safe and well tolerated. Dried plums are safe, palatable and more effective than psyllium for the treatment of mild to moderate constipation, and should be considered as a first line therapy.

Glucomannan is not effective for the treatment of functional constipation in children: A double-blind, placebo-controlled, randomized trial

Treatment measures for constipation in children are often not satisfactory. The aim was to assess the efficacy of glucomannan (GNN) as a sole treatment for functional constipation. Children aged 3-16 years with functional constipation according to Rome III criteria were randomly assigned to receive GNN (2.52g/d) or placebo for 4 weeks. Of the 80 children, 72 (90%) completed the study. The primary outcome, treatment success (≥3 stools per week with no soiling), was similar in the GNN (n=36) and placebo (n=36) groups (relative risk 0.95, 95% CI 0.6 to 1.4). In the GNN group, the stool consistency score was higher at week 1 (P<0.0001), lower at week 3 (P=0.008), and similar at weeks 2 and 4. Stool frequency was higher only at week 3 (P=0.007). Abdominal pain episodes were more frequent in the GNN group at week 1 (P=0.04) and week 4 (P<0.0001) but were similar between groups at weeks 2 and 3. No difference was observed in the frequency of any other secondary outcome or adverse event. In our setting, GNN, as dosed in this study, was not more effective than placebo in achieving therapeutic success in constipated children. The trial was registered at ClinicalTrials.gov (http://clinicaltrials.gov), number NCT01151878.

Bacillus Coagulans GBI-30 (BC30) improves indices of Clostridium difficile-Induced colitis in mice

BackgroundProbiotics have beneficial effects in rodent models of Clostridium difficile (C. diffiicle)-induced colitis. The spore forming probiotic strain Bacillus Coagulans GBI-30, 6086 (BC30) has demonstrated anti-inflammatory and immune-modulating effects in vitro. Our goal was to determine if BC30 improved C. difficile-induced colitis in mice. Starting on study day 0, female C57BL/6 mice were dosed by oro-gastric gavage for 15 days with vehicle (saline) or BC30 (2 × 109 CFU per day). Mice in the C. difficile groups received an antibiotic mixture (study days 5 to 8 in the drinking water), and clindamycin (10 mg/kg, i.p., on study day 10). The C. difficile strain VPI 10463 was given by gavage at 104 CFU to induce colitis on day 11. On day 16, stools and colons were collected for further analyses.ResultsAll mice treated with BC30 survived on study day 13, while two mice treated with vehicle did not survive. On day 12, a significant difference (p = 0.0002) in the percentage of mice with normal stools (66.7%) was found in the BC30/C. difficile group, as compared to the vehicle/C. diffcile group (13.0%). On study day 16, 23.8% of mice treated with BC30 had normal stools, while this value was 0% with vehicle treatment (p value = 0.0187). On this day, the stool consistency score for the BC30/C. difficile group (1.1 ± 0.2) was significantly lower (p < 0.05) than for the vehicle/C. difficile cohort (1.9 ± 0.2). BC30 modestly attenuated the colonic pathology (crypt damage, edema, leukocyte influx) that was present following C. difficile infection. Colonic MIP-2 chemokine contents (pg/2 cm colon) were: 10.2 ± 0.5 (vehicle/no C. difficile), 24.6 ± 9.5 (vehicle/C. difficile) and 16.3 ± 4.3 (BC30/C. difficle).ConclusionThe probiotic BC30 improved some parameters of C. difficile-induced colitis in mice. BC30 prolonged the survival of C. diffiicle infected mice. Particularly, this probiotic improved the stool consistency of mice, in this infectious colitis model.

Oral administration of docosahexaenoic acid attenuates colitis induced by dextran sulfate sodium in mice

Dietary supplementation of n-3 PUFAs, containing docosahexaenoic acid (DHA), modulates the symptoms of colitis. Hence, we investigated the effects of oral administration of pure DHA and the therapeutic agent sulfasalazine (SAL) on chemically induced colitis in mice, and analyzed the expression levels of DHA-responsive genes in colonic tissue using cDNA arrays. Colitis in BALB/c mice was induced by feeding 5% dextran sulfate sodium (DSS) in drinking water for 7 days. DHA (30 mg/kg/day, DHA) or SAL (100 mg/kg/day, SAL) was administered orally throughout the treatment along with DSS. The DHA-treated group showed significant reduction of the weight loss and colon shortening compared to the DSS-treated colitis group. In contrast, SAL treatment was effective in reducing colon shortening, stool consistency and bleeding scores. DHA and SAL treatments also significantly reduced the changes in inflammation of the colon, and reversed the increase in myeloperoxidase activity induced by DSS. Among DSS-responsive genes, those for inflammatory cytokines (IL-1β, CD14 antigen and tumor necrosis factor receptor superfamily, member 1b), membrane remodeling genes (matrix metalloproteinase-3, -10 and -13) and acute phase proteins (S100 calcium-binding protein A8), which were increased by DSS, were downregulated by DHA or SAL treatment. DHA was effective in alleviating DSS-induced colitis in mice, partly by modulating the expression levels of genes involved in colitis.