Safety Of Rifaximin Research Articles

Efficacy and safety of rifaximin in patients with chronic intestinal pseudo-obstruction: a randomized, double-blind, placebo-controlled, phase II-a exploratory trial.

Chronic intestinal pseudo-obstruction (CIPO) is a rare intractable disease with limited treatment options. Small intestinal bacterial overgrowth (SIBO) often co-occurs with several diseases, including CIPO. While rifaximin (RFX) is effective in treating SIBO, its efficacy for CIPO remains unclear. Here, we aimed to investigate the efficacy and safety of RFX in adult patients with CIPO. Twelve patients were randomly assigned to receive RFX (400 mg three times daily, n=8) or a placebo (PBO, n=4) for 4 weeks. The global symptom score for abdominal bloating (GSS-bloating) and an original whole gastrointestinal symptoms score (O-WGSS) were collected, and a glucose hydrogen breath test (GHBT) and abdominal computed tomography (CT) were performed. No significant differences were observed in the primary endpoint. GSS-bloating improved by 75% and 25% in the PBO and RFX groups, respectively, and O-WGSS improved by 25% in both groups. No significant differences were observed in secondary and other endpoints, including the SIBO eradication rate in the GHBT and small intestinal volume on CT. In a post hoc analysis of SIBO-positive patients with CIPO (4/4 and 4/8 in the PBO and RFX groups), SIBO was eradicated in 25% and 75% of the patients (PBO and RFX groups, respectively) at the end of treatment, indicating a high eradication rate in the RFX group. Furthermore, the small intestinal gas volume decreased in the RFX group, and no severe adverse events occurred. Although no significant improvements were observed in subjective indicators, RFX may be beneficial in alleviating SIBO and reducing the small intestinal gas volume in SIBO-positive patients with CIPO.

Efficacy and Safety of Rifaximin in the Prevention of Recurrent Episodes of Hepatic Encephalopathy: A Systematic Review and Meta-analysis.

Rifaximin is an oral antimicrobial drug with a broad-spectrum effect. It locally regulates the function and structure of intestinal bacteria and decreases intestinal endotoxemia. We aimed to investigate the preventive role of rifaximin in recurrent episodes of hepatic encephalopathy in cases with a history of hepatic diseases. We searched PubMed, Scopus, and Web of Science for the relevant studies using the following search strategy: "(Rifaximin) OR (Xifaxan) AND (cirrhosis) OR (encephalopathy)." We assessed the risk of bias using Cochrane's risk of bias tool. We included the following outcomes: recurrence of hepatic encephalopathy, adverse events, mortality rate, and time to the first episode of hepatic encephalopathy from the time of randomization (days). We performed the analysis of homogeneous data under the fixed-effects model, while analysis of heterogeneous data was performed under the random-effects model. We analyzed data obtained from 999 patients from 7 included trials. The overall risk ratio proved that the rifaximin group was associated with a lower recurrence rate than the control group (risk ratio [RR] = 0.61[0.50, 0.73], P = .001). We found no significant variation in both groups regarding adverse events (RR = 1.08 [0.89, 1.32], P = .41), and mortality rates (RR = 0.98 [0.61, 1.57], P = .93). The overall risk of bias results was low. The meta-analysis showed that in patients allocated to the rifaximin group, the incidence rate of hepatic encephalopathy was significantly lower when compared with those in the control group with no difference in both groups regarding adverse events and mortality rates.

Rifaximin Modifies Gut Microbiota and Attenuates Inflammation in Parkinson's Disease: Preclinical and Clinical Studies.

Patients with Parkinson's disease (PD) exhibit distinct gut microbiota, which may promote gut-derived inflammation. Rifaximin is a nonabsorbable antibiotic that can modify gut microbiota. The present study investigated the effect of rifaximin on gut microbiota and inflammation status in PD. The study examined the effect of long-term rifaximin treatment on in vivo transgenic PD mice (MitoPark) and short-term rifaximin treatment on patients with PD. Rifaximin treatment caused a significant change in gut microbiota in the transgenic PD mice; in particular, it reduced the relative abundance of Prevotellaceae UCG-001 and increased the relative abundance of Bacteroides, Muribaculum, and Lachnospiraceae UCG-001. Rifaximin treatment attenuated serum interleukin-1β, interleukin-6 and tumor necrosis factor-α, claudin-5 and occludin, which indicated the reduction of systemic inflammation and the protection of the blood-brain barrier integrity. The rifaximin-treated MitoPark mice exhibited better motor and memory performance than did the control mice, with lower microglial activation and increased neuronal survival in the hippocampus. In the patients with PD, 7-day rifaximin treatment caused an increase in the relative abundance of Flavonifractor 6 months after treatment, and the change in plasma proinflammatory cytokine levels was negatively associated with the baseline plasma interleukin-1α level. In conclusion, the present study demonstrated that rifaximin exerted a neuroprotective effect on the transgenic PD mice by modulating gut microbiota. We observed that patients with higher baseline inflammation possibly benefited from rifaximin treatment. With consideration for the tolerability and safety of rifaximin, randomized controlled trials should investigate the disease-modification effect of long-term treatment on select patients with PD.

Long-Term Efficacy and Safety of Rifaximin in Japanese Patients with Hepatic Encephalopathy: A Multicenter Retrospective Study.

Background: Rifaximin is commonly used for hepatic encephalopathy (HE). However, the effects of long-term treatment for Japanese people are limited. Therefore, this study aimed to investigate the effects and safety of long-term treatment with rifaximin on HE. Methods: A total of 215 patients with cirrhosis administered with rifaximin developed overt or covert HE, which was diagnosed by an attending physician for >12 months. Laboratory data were extracted at pretreatment and 3, 6, and 12 months after rifaximin administration. The long-term effect of rifaximin was evaluated, and the incidence of overt HE during 12 months and adverse events was extracted. Results: Ammonia levels were significantly improved after 3 months of rifaximin administration and were continued until 12 months. There were no serious adverse events after rifaximin administration. The number of overt HE incidents was 9, 14, and 27 patients within 3, 6, and 12 months, respectively. Liver enzymes, renal function, and electrolytes did not change after rifaximin administration. Prothrombin activity is a significant risk factor for the occurrence of overt HE. The serum albumin, prothrombin activity, and albumin–bilirubin (ALBI) scores were statistically improved after 3 and 6 months of rifaximin administration. Moreover, the same results were obtained in patients with Child–Pugh C. Conclusions: The long-term rifaximin treatment was effective and safe for patients with HE, including Child–Pugh C.

Russian Non-Interventional Study of the Efficacy and Tolerability of Rifaximin-α Therapy in Patients with Uncomplicated Diverticular Disease under the Conditions of Outpatient Practice

Aim. This observational (non-interventional) study was aimed at obtaining data on practitioners’ commitment to prescribing rifaximin- α therapy to patients with uncomplicated diverticular disease (UDD), to assess patients’ adherence to such prescriptions, as well as to assess physicians’ and patients’ satisfaction with this drug under the conditions of outpatient practice. Materials and methods . 27 research physicians in 22 research centres located in 15 Russian cities and 250 patients participated in an open, prospective multicentre observational study. The observation lasted for 6 months with an interim assessment after 3 months. Physicians’ prescription of rifaximin- α (dose, duration of administration, number of prescribed courses) was evaluated, as well as patients’ compliance expressed as the ratio of the actual number of taken pills to the number of prescribed pills during each course according to the MMAS-4 scale. Such symptoms, as abdominal pain, constipation, diarrhea, flatulence and tenesmus were evaluated using a 4-score scale. At the end of the study, physicians’ and patients’ satisfaction with the treatment was evaluated using a 5-score scale. Results . One fifth — 52 patients (20.8%)—had received rifaximin- α therapy prior to inclusion in the study. Most frequently, rifaximin- α therapy was prescribed monthly at a dose of 400 mg 2 times a day for 7 days. 67.6% of patients received 6 courses of treatment during the study period. The proportion of patients who received more than one course of treatment over 6 months was 97.6%. During almost all treatment courses (97.5%), patients’ compliance was more than 80%. The total score of symptom intensity decreased from 5.6 at the inclusion visit, to 2.2 points at the second visit and to 0.9 points at the end of the observation. A statistically significant (p <0.05) positive dynamics was observed in relation to all evaluated symptoms (abdominal pain, constipation, diarrhea, flatulence, tenesmus). By the end of the study, 59.6% of patients and 68.8% of physicians rated the treatment results as “excellent”, 25.2% of patients and 20.4% of doctors as “good”. Conclusions . During the observation, a significant decrease in the severity of UDD symptoms, such as abdominal pain, constipation, diarrhea, flatulence and tenesmus was noted. No adverse effects associated with rifaximin- α were reported. The data obtained confirm the previously published results of randomized controlled trials on the efficacy and safety of rifaximin- α in UDD.

The efficacy and safety of Rifaximin in the management of hepatic encephalopathy

The efficacy and safety of Rifaximin in the management of hepatic encephalopathy

Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 Trial

Efficacy and Safety of Rifaximin for Patients With Chronic Intestinal Pseudo-obstruction: a Phase 2 Trial

Efficacy and safety of rifaximin in Japanese patients with hepatic encephalopathy: A phase II/III, multicenter, randomized, evaluator-blinded, active-controlled trial and a phase III, multicenter, open trial.

The efficacy and safety of rifaximin in the treatment of hepatic encephalopathy (HE) are widely known, but they have not been confirmed in Japanese patients with HE. Thus, two prospective, randomized studies (a phase II/III study and a phase III study) were carried out. Subjects with grade I or II HE and hyperammonemia were enrolled. The phase II/III study, which was a randomized, evaluator-blinded, active-comparator, parallel-group study, was undertaken at 37 institutions in Japan. Treatment periods were 14 days. Eligible patients were randomized to the rifaximin group (1200 mg/day) or the lactitol group (18-36 g/day). The phase III study was carried out in the same patients previously enrolled in the phase II/III study, and they were all treated with rifaximin (1200 mg/day) for 10 weeks. In the phase II/III study, 172 patients were enrolled. Blood ammonia (B-NH3 ) concentration was significantly improved in the rifaximin group, but the difference between the two groups was not significant. The portal systemic encephalopathy index (PSE index), including HE grade, was significantly improved in both groups. In the phase III study, 87.3% of enrolled patients completed the treatment. The improved B-NH3 concentration and PSE index were well maintained from the phase II/III study during the treatment period of the phase III study. Adverse drug reactions (ADRs) were seen in 13.4% of patients who received rifaximin, but there were no severe ADRs leading to death. The efficacy of rifaximin is sufficient and treatment is well tolerated in Japanese patients with HE and hyperammonemia.

Rifaximin versus norfloxacin for prevention of spontaneous bacterial peritonitis: a systematic review

AimThe aim of this systematic review is to evaluate the efficacy and safety of rifaximin in the prophylaxis of spontaneous bacterial peritonitis (SBP) as compared with norfloxacin.MethodsWe searched MEDLINE, CINAHL,...

Rifaximin for the Prevention and Treatment of Hepatic Encephalopathy: A Systematic Review With Meta-Analyses of Randomised Controlled Trials

Background: The main licensed indication for rifaximin is the prevention of recurrent hepatic encephalopathy (HE) after an index event although many early trials showed it was an efficacious treatment for both acute and chronic HE. The aim of this study was to assess the efficacy and safety of rifaximin in patients with cirrhosis by undertaking meta-analyses of RCTs comparing rifaximin vs. placebo/no intervention or vs. non-absorbable disaccharides (NADs). Methods: Electronic and manual searches of the literature were undertaken; further information was obtained from trialists and pharmaceutical companies. Meta-analyses were conducted and results presented as relative risks (RR) and 95% confidence intervals (CI). Sources of heterogeneity and the influence of random and systematic errors were evaluated in subgroup and trial sequential analyses. Results: A total of 21 RCTs involving 2258 patients were included. Individual patient data were obtained from five trials and unpublished information from 10 trials. Rifaximin showed a beneficial effect on mortality compared with placebo/no intervention when including all 11 RCTs (RR 0.58, 0.44–0.77; participants = 1129). Subgroup analyses showed that rifaximin reduced mortality in overt HE (0.50, 0.36–0.71), but not in minimal HE (0.50, 0.20–1.22), or in the prevention trials (1.01, 0.54–1.88) or when excluding the five RCTs in which NADs were used as co-intervention (0.74, 0.31–1.77) (Figure 1). Additional analyses showed a beneficial effect of rifaximin on overt HE (0.62, 0.41–0.93) and minimal HE (0.43, 0.30–0.62), but not in the prevention of HE (0.80, 0.45–1.42) or in an analysis that excluded RCTs in which NADs were used as co-invention (0.64, 0.39–1.04). Rifaximin reduced the risk of serious adverse events (SAE) (0.65, 0.51–0.84) and had a potential beneficial effect on Quality of Life (MD −2.05, −2.78 to −1.32). In meta-analyses of six RCTs comparing rifaximin vs. NADs, it had no effect on mortality (0.86, 0.42–1.77; participants = 447); it had a beneficial effect on overt HE (0.64, 0.43–0.93), but not minimal HE (0.85, 0.47–1.53) or in the prevention trials (0.89, 0.51–1.57); it did not reduce the risk of SAEs (RR 0.89, 0.56–1.42). Conclusion: There is moderate to low quality evidence that rifaximin combined with NADs is a safe and effective intervention for patients with cirrhosis and overt or minimal HE and for the prevention of recurrent HE after an index event. Disclosures/Financial Association: Nina Kimer has received rifaximin and placebo tablets, and an unrestricted grant from Norgine for a clinical trial. The authors have none to declare.

A Randomized, Double-Blind, Controlled Trial Comparing Rifaximin Plus Lactulose With Lactulose Alone in Treatment of Overt Hepatic Encephalopathy

Hepatic encephalopathy (HE) is associated with poor prognosis in cirrhosis. Drugs used in the treatment of HE are primarily directed at the reduction of the blood ammonia levels. Rifaximin and lactulose have shown to be effective in HE. We evaluated the efficacy and safety of rifaximin plus lactulose vs. lactulose alone for treatment of overt HE. In this prospective double-blind randomized controlled trial, 120 patients with overt HE were randomized into two groups: (group A lactulose plus rifaximin 1,200 mg/day; n=63) and group B (lactulose (n=57) plus placebo). The primary end point was complete reversal of HE and the secondary end points were mortality and hospital stay. A total of 120 patients (mean age 39.4±9.6 years; male/female ratio 89:31) were included in the study. 37 (30.8%) patients were in Child-Turcotte-Pugh (CTP) class B and 83 (69.2%) were in CTP class C. Mean CTP score was 9.7±2.8 and the MELD (model for end-stage liver disease) score was 24.6±4.2. At the time of admission, 22 patients (18.3%) had grade 2, 40 (33.3%) had grade 3, and 58 (48.3%) had grade 4 HE. Of the patients, 48 (76%) in group A compared with 29 (50.8%) in group B had complete reversal of HE (P<0.004). There was a significant decrease in mortality after treatment with lactulose plus rifaximin vs. lactulose and placebo (23.8% vs. 49.1%, P<0.05). There were significantly more deaths in group B because of sepsis (group A vs. group B: 7:17, P=0.01), whereas there were no differences because of gastrointestinal bleed (group A vs. group B: 4:4, P=nonsignificant (NS)) and hepatorenal syndrome (group A vs. group B: 4:7, P=NS). Patients in the lactulose plus rifaximin group had shorter hospital stay (5.8±3.4 vs. 8.2±4.6 days, P=0.001). Combination of lactulose plus rifaximin is more effective than lactulose alone in the treatment of overt HE.

A randomised double blind controlled trial comparing rifaximin plus lactulose with lactulose alone in treatment of hepatic encephalopathy

Background and Aims: Hepatic encephalopathy (HE) is associated with poor prognosis in cirrhosis. Majority of the drugs used in the treatment of HE are primarily directed at the reduction or elimination of the blood ammonia levels. We evaluated the efficacy and safety of rifaximin plus lactulose versus lactulose alone for treatment of overt hepatic encephalopathy. Methods: In prospective double blind randomized controlled trial, 120 patients with overt HE were randomized in 2 groups, group 1- lactulose (n=57) and group 2- lactulose plus rifaximin (n=63). Primary end point was reversal of hepatic encephalopathy. Secondary end points were mortality and hospital stay. Results: One hundred and twenty patients (mean age 39.4 ± 9.6 years; M: F 89:31) were included in study. Thirty seven (30.8%) patients were in Child-Turcotte-Pugh (CTP) class B and 83 (69.2%) were in CTP Class C. Mean CTP score was 9.7 ± 2.8 and MELD score was 24.6 ± 4.2. 22 (18.3%) had grade 2, 40 (33.3%) had grade 3 and 58 (48.3%) had grade 4 HE at the time of admission. Forty eight (76%) patients in group 2 compared to 29 (50.8%) patients in group 1 had reversal of HE (P<0.004). There was significant decrease in mortality after treatment with lactulose plus rifaximin versus lactulose alone (23.8% Vs 49.1%, P <0.05). Most common cause of death was sepsis (n=43, 55.8%), followed by hepatorenal syndrome (n=11, 25.6%) and GI bleed (n=8, 18.6%). There was no significant difference in cause of death in two groups. Patients in latulose plus rifaximin group had shorter hospital stay (5.8 ± 3.4 vs. 8.2 ± 4.6 days, P =0.001). Conclusions: Combination of lactulose plus rifaximin is more effective than lactulose alone in treatment of HE.

Rifaximin versus Nonabsorbable Disaccharides for the Treatment of Hepatic Encephalopathy: A Meta-Analysis

Background. Many studies have found that the antibiotic rifaximin is effective for the treatment of hepatic encephalopathy. However, there is no uniform view on the efficacy and safety of rifaximin. Methods. We performed a meta-analysis through electronic searches to evaluate the efficacy and safety of rifaximin in comparison with nonabsorbable disaccharides. Results. A total of 8 randomized controlled trials including 407 patients were included. The efficacy of rifaximin was equivalent to nonabsorbable disaccharides according to the statistical data (risk ratio (RR): 1.06, 95% CI: 0.94–1.19; P = 0.34). Analysis showed that patients treated with rifaximin had better results in serum ammonia levels (weighted mean difference (WMD): −10.63, 95% CI: −30.63–9.38; P = 0.30), mental status (WMD: −0.32, 95% CI: −0.67–0.03; P = 0.07), asterixis (WMD: −0.12, 95% CI: −0.31–0.08; P = 0.23), electroencephalogram response (WMD: −0.21, 95% CI: −0.34–−0.09; P = 0.0007), and grades of portosystemic encephalopathy (WMD: −2.30, 95% CI: −2.78–−1.82; P < 0.00001), but only the last ones had statistical significance. The safety of rifaximin was better than nonabsorbable disaccharides (RR: 0.19, 95% CI: 0.10–0.34; P < 0.00001). Conclusion. Rifaximin is at least as effective as nonabsorbable disaccharides, maybe better for the treatment of hepatic encephalopathy. And the safety of rifaximin is better.

Effectiveness of rifaximin and fluoroquinolones in preventing travelers’ diarrhea (TD): a systematic review and meta-analysis

BackgroundRecent developments related to a safe and effective nonabsorbable antibiotic, rifaximin, and identification of postinfectious irritable bowel syndrome as a frequent sequela call for a need to reconsider the value of primary prevention of traveler’s diarrhea (TD) with antibiotics.MethodsRandomized, placebo-controlled, double-blind studies evaluating the effectiveness and safety of rifaximin or a fluoroquinolone chemoprophylaxis against TD were pooled using a random effects model and assessed for heterogeneity.ResultsThe nine studies (four rifaximin and five fluoroquinolone) included resulted in pooled relative risk estimates of 0.33 (95% CI = 0.24–0.45, I2 = 3.1%) and 0.12 (95% CI = 0.07–0.20, I2 =0.0%), respectively. Similar rates of treatment emergent adverse events were found between antibiotic and placebo groups.ConclusionsThis meta-analysis supports the effectiveness of antibiotics in preventing TD. However, further studies that include prevention of secondary chronic health outcomes among travelers to different geographic regions, and a formal risk-benefit analysis for antibiotic chemoprophylaxis, are needed.

Mo1116 The Efficacy and Safety of Rifaximin vs. Vancomycin in the Treatment of Mild to Moderate C. difficile Infection: A Randomized Double-Blind Active Comparator Trial

Mo1116 The Efficacy and Safety of Rifaximin vs. Vancomycin in the Treatment of Mild to Moderate C. difficile Infection: A Randomized Double-Blind Active Comparator Trial

168 The Long Term Efficacy and Safety of Rifaximin in the Maintenance of Remission From Overt Hepatic Encephalopathy in Cirrhotic Patients

168 The Long Term Efficacy and Safety of Rifaximin in the Maintenance of Remission From Overt Hepatic Encephalopathy in Cirrhotic Patients

Rifaximin Is Effective for the Treatment ofClostridium difficile—Associated Diarrhea: Results of an Open-Label Pilot Study

Objectives. This open-label trial assessed the efficacy and safety of rifaximin as first-line therapy in hospitalized patients with Clostridium difficile-associated diarrhea (CDAD). Methods. We enrolled thirteen patients who had a confirmed diagnosis of CDAD characterized by ≥3 unformed stools/day and positive C. difficile toxin assay. Those patients received rifaximin 400 mg three times daily for 10 days. Resolution of symptoms, repeat assay 10 days after treatment, and followup for recurrence were assessed. Results. Eight patients completed the study, and all reported symptom resolution during treatment. Mean time to last unformed stool was 132 h ± 42.5 h. Seven patients had no relapse by week 2 and in longer followup (median 162 days). One patient had recurrent CDAD during a repeat hospitalization. Conclusions. Rifaximin was effective and safe as first-line treatment for CDAD and did not result in recurrence in most patients.

Rifaximin for the Treatment of Hepatic Encephalopathy

Background Previous studies suggest that rifaximin is efficacious in the treatment of hepatic encephalopathy. Objective To evaluate the efficacy and safety of rifaximin in addition to lactulose in improving hospitalization outcomes in patients with hepatic encephalopathy. Methods Hospital records of patients evaluated for liver transplantation at a single center between January 2006 and May 2008 were reviewed. Hospitalizations for hepatic encephalopathy and other conditions and the incidence of spontaneous bacterial peritonitis and adverse events were analyzed. Results Charts of 65 patients who were treated with rifaximin and lactulose were analyzed. Patients received lactulose (20–120 g/d; lactulose phase) before treatment with rifaximin (400– 1200 mg/d; rifaximin phase). During the rifaximin phase, the risk, number, and duration of hospitalizations for hepatic encephalopathy were reduced compared with the lactulose phase. Treatment, age, and Model for End-Stage Liver Disease score were independent predictors of hospitalizations for hepatic encephalopathy ( P < .05). The rifaximin phase had fewer hospitalizations than the lactulose phase (36 vs 47, respectively) and a smaller percentage of patients with repeated hospitalizations than the lactulose phase (5% vs 14%, respectively; P = .006) for conditions other than hepatic encephalopathy. A smaller percentage of patients had evidence of spontaneous bacterial peritonitis during the rifaximin phase than the lactulose phase (2% vs 12%, respectively; P = .02). Rifaximin was better tolerated than lactulose. Conclusions Addition of rifaximin to lactulose therapy significantly reduced the risk and duration of hospitalizations for hepatic encephalopathy.

Treatment Options for Hepatic Encephalopathy

Few formal treatment guidelines exist for managing hepatic encephalopathy. The nonabsorbable disaccharide, lactulose, is considered the first-line therapeutic agent for treating hepatic encephalopathy. Acidification of the gastrointestinal tract is the principal mechanism by which the drug inhibits production of ammonia by coliform bacteria. Elevated ammonia levels are seen in more than 80% of patients with hepatic encephalopathy. Systemic antibiotics, primarily neomycin, have also been employed to reduce bacterial production of ammonia, but associated adverse events limit their use in patients with hepatic encephalopathy. The semisynthetic, nonsystemic antibiotic, rifaximin, was approved in March 2010 by the United States Food and Drug Administration for the treatment of overt hepatic encephalopathy. Rifaximin decreases intestinal production and absorption of ammonia by altering gastrointestinal flora and is almost completely excreted unchanged in the feces. Rifaximin has been effective in improving behavioral, laboratory, mental, and intellectual abnormalities in patients with hepatic encephalopathy. The drug was compared with lactulose in well-designed clinical studies in patients with hepatic encephalopathy. Rifaximin was generally found to be equal or superior to lactulose in these studies. Although dosages have varied, most medical centers use a dosage of rifaximin 400 mg 3 times/day for hepatic encephalopathy. Recent clinical trials have used 550 mg twice/day in order to improve patient compliance. Additional clinical trials are being undertaken to further define the efficacy and safety of rifaximin in hepatic encephalopathy.

Use and Safety of Rifaximin in Children With Inflammatory Bowel Disease

Rifaximin, Food and Drug Administration approved for traveler's diarrhea, has been used in adult patients with active inflammatory bowel disease (IBD). This retrospective review was undertaken to determine its role in the treatment of pediatric IBD. A review of children with IBD, who were treated with rifaximin from 2005 to 2007 at our institution, was performed. Collected data included diagnosis, age, medication history, recent therapy, symptom, and interval to improvement. Response was rated as none, moderate, or optimum relief for each symptom. Twenty-three patients were identified, 12 with Crohn disease and 11 with ulcerative colitis (UC) with a median age of 13 years. The most common complaints were diarrhea in 20 patients (87%), abdominal pain in 17 (74%), and bloody stools in 15 (65%). Rifaximin was given at doses ranging between 10 and 30 mg/kg (Table 1). Of the 20 patients who presented with diarrhea 5 (25%) had relief of diarrhea within 1 week of starting rifaximin and total of 12 patients (60%) experienced relief within 4 weeks. Abdominal pain resolved in 3 of 17 patients (17.6%) within 1 week and in 12 of 17 (70.6%) within 4 weeks. Visible bleeding resolved in 10 of 15 patients (66.7%) within 4 weeks of therapy (Table 2). Analysis of concurrent medications showed 61% experienced relief of symptoms when addition of rifaximin was the only meaningful treatment change. Rifaximin was well-tolerated and showed favorable results. Larger doses of rifaximin were statistically better for abdominal pain. Further studies are needed to evaluate efficacy and optimal dosing of rifaximin in this population.