Assessment Of Gastrointestinal Symptoms Research Articles

Assessment of gastrointestinal symptoms and dietary intake in peritoneal dialysis patients in Slovenia

Assessment of gastrointestinal symptoms and dietary intake in peritoneal dialysis patients in Slovenia

Laparoscopic proximal gastrectomy with right-sided overlap and single-flap valvuloplasty (ROSF): a case-series study

BackgroundThere is no standard reconstruction method following proximal gastrectomy, of which gastroesophageal reflux and anastomotic complications are of great concern. Though several techniques have been devised to overcome these postoperative complications, such as double tract reconstruction, double-flap technique and side overlap fundoplication by Yamashita, none of them is considered a perfect solution. Herein, we designed a novel method of esophagogastrostomy after laparoscopic proximal gastrectomy (LPG), named right-sided overlap and single-flap valvuloplasty (ROSF).MethodsBetween March 2021 and December 2021, 20 consecutive patients underwent LPG-ROSF at Department of Gastrointestinal Surgery, Second Affiliated Hospital of Soochow University. Surgical outcomes and postoperative complications were recorded. All patients were followed-up until December 2022. Endoscopy and assessment of gastrointestinal symptoms were performed 1 year after surgery. Nutrition-related parameters including total body weight, hemoglobin, lymphocyte count, serum total protein, serum albumin and serum prealbumin were evaluated 1 year after surgery and compared with those before surgery.ResultsThe mean surgery time and anastomosis time was 285.3 ± 71.3 and 61.3 ± 11.2 min respectively. None of the patients had gastrointestinal early postoperative complications. Symptomatic reflux was observed in one patient (5%) while reflux esophagitis (Los Angeles Grade A) was observed in another patient (5%). Four patients (20%) had mild dysphagia (Visick score = II) but none of them had anastomotic stenosis. There were no significant changes in nutritional status postoperatively.ConclusionsROSF can be safely performed after LPG and has satisfactory outcomes in preventing reflux and stenosis, and maintaining nutritional status. This technique requires further validation.

Plasma Metabolic and Lipidomic Fingerprinting of Individuals with Increased Intestinal Permeability.

The dual-sugar intestinal permeability test is a commonly used test to assess changes in gut barrier function. However, it does not identify functional changes and the exact mechanism of damage caused by the increased intestinal permeability. This study aims to explore the application of untargeted metabolomics and lipidomics to identify markers of increased intestinal permeability. Fifty fasting male participants (18–50 years) attended a single visit to conduct the following procedures: assessment of anthropometric measures, assessment of gastrointestinal symptoms, intestinal permeability test, and assessment of blood samples 90 min post-administration of the intestinal permeability test. Rhamnose and lactulose were analysed using gas chromatography-mass spectrometry (GC-MS). Untargeted polar metabolites and lipidomics were assessed by liquid chromatography quadrupole time-of-flight mass spectrometry (LC-QToF MS). There was an elevated lactulose/rhamnose ratio in 27 subjects, indicating increased permeability compared to the remaining 23 control subjects. There were no significant differences between groups in characteristics such as age, body mass index (BMI), weight, height, and waist conference. Fourteen metabolites from the targeted metabolomics data were identified as statistically significant in the plasma samples from intestinal permeability subjects. The untargeted metabolomics and lipidomics analyses yielded fifteen and fifty-one statistically significant features, respectively. Individuals with slightly elevated intestinal permeability had altered energy, nucleotide, and amino acid metabolism, in addition to increased glutamine levels. Whether these biomarkers may be used to predict the early onset of leaky gut warrants further investigation.

Assessment of Gastrointestinal Symptoms and Dyspnea in Patients Hospitalized due to COVID-19: Contribution to Clinical Course and Mortality.

Gastrointestinal manifestations may accompany the respiratory symptoms of COVID-19. Abdominal pain (AP) without nausea and vomiting is one of the most common. To date, its role and prognostic value in patients with COVID-19 is still debated. Therefore, we performed a retrospective analysis of 2184 individuals admitted to hospital due to COVID-19. We divided the patients into four groups according to presented symptoms: dyspnea, n = 871 (39.9%); AP, n = 97 (4.4%); AP with dyspnea together, n = 50 (2.3%); and patients without dyspnea and AP, n = 1166 (53.4%). The patients with AP showed tendency to be younger than these with dyspnea, but without AP (63.0 [38.0–70.0] vs. 65.0 [52.0–74.0] years, p = 0.061), and they were more often females as compared to patients with dyspnea (57.7% vs. 44.6%, p = 0.013, for females). Patients with AP as a separate sign of COVID-19 significantly less often developed pneumonia as compared to individuals with dyspnea or with dyspnea and AP together (p < 0.0001). Patients with AP or AP with dyspnea were significantly less frequently intubated or transferred to the intensive care unit (p = 0.003 and p = 0.031, respectively). Individuals with AP alone or with dyspnea had significantly lower rate of mortality as compared to patients with dyspnea (p = 0.003). AP as a separate symptom and also as a coexisting sign with dyspnea does not predispose the patients with COVID-19 to the worse clinical course and higher mortality.

Gastrointestinal symptoms and sensory abnormalities associated with behavioral problems in children with neurodevelopmental disorders.

Behavioral problems directly affect the quality of life of caregivers and children with autism spectrum disorder (ASD) and/or attention-deficit/hyperactivity disorder (ADHD), and is known to be associated with clinical factors such as gastrointestinal (GI) symptoms, sensory abnormalities, intellectual abilities, and use of medication. However, previous studies have not considered these relationships comprehensively. We conducted a cross-sectional study of 6-12-year-old children with diagnoses of ASD and/or ADHD at two hospitals in Japan. Scores for the aberrant behavior checklist (ABC), autism-spectrum quotient (AQ), and Conners 3, as well as information on daily sleep and exercise, GI symptoms, and Short Sensory Profile, were collected. Each factor was subjected to a correlation analysis to investigate its effect on ABC scores. A stepwise multiple linear regression analysis for the factors with p < 0.05 was performed. Data were obtained from 60 patients with a mean age of 8.3 years; 21 had ASD alone, 18 had ADHD alone, and 21 had ASD + ADHD. The correlation analyses identified six factors associated with ABC severity: (a) methylphenidate use, (b) Conners hyperactivity score, (c) Conners inattention score, (d) AQ score, (e) SSP score, and (f) GI symptom score. The multiple regression showed that "GI symptoms" and "sensory abnormalities" were independently associated with ABC severity. Although further studies are needed to show a causal relationship, appropriate assessment of GI symptoms and sensory abnormalities may help alleviate some problematic behaviors and improve the quality of life of children with neurodevelopmental disorders and their families. LAY SUMMARY: Behavioral problems in children with neurodevelopmental disorders are known to be associated with many factors. This study aimed to comprehensively investigate the known factors. We have discovered that "gastrointestinal symptoms" and "sensory abnormalities" were independently associated with Behavioral problems. Our results suggest that it is important for clinicians and caregivers to pay more attention to children's GI symptoms and sensory abnormalities that may not present as obvious symptoms or complaints.

Clinical Spectrum in a Cohort of Patients With High Fecal Calprotectin Levels.

Introduction: Distinguishing between inflammatory bowel disease (IBD) and functional gastrointestinal disorders is a diagnostic challenge. The need for non-invasive biomarker as a diagnostic tool in the assessment of gastrointestinal symptoms is required. The objectives of current study were to determine the spectrum of clinical features in patients tested for fecal calprotectin presenting with high levels and to compare calprotectin levels among already diagnosed patients known to have IBD as per biopsy findings and documented on patients' file with newly presenting patients who were being investigated and did not have a diagnosis.Methods: This retrospective cross-sectional study was conducted in the Department of Pathology and Laboratory Medicine and Department of Medicine, Aga Khan University, Karachi, Pakistan from January 2017 to December 2019. Subjects tested for fecal calprotectin who had elevated fecal calprotectin levels (n = 150) were included in the current study. Each patient deposited a random stool sample in an airtight container for calprotectin analysis. Biochemical analysis of calprotectin was performed by enzyme-linked immunosorbent assay using epitope calprotectin test kit (Epitope Diagnostics, Italy) on ETI-Max 3000 immunoassay analyzer (DiaSorin, Italy). A structured history form was used for data collection. Results: One hundred and fifty patients were available for inclusion in the final analysis. Majority of the patients (n = 117, 78%) were adults (>18 years of age), and 52.7% (n = 79) were females. Median fecal calprotectin (IQR) was 317.3 μg/g (549.10 - 239.2 μg/g) in children (n = 33) and 305 μg/g (609.9 - 201.6 μg/g) in adults; the difference was statistically non-significant (p value > 0.05). On categorization according to disease, fecal calprotectin levels were significantly elevated (p value = 0.033) in IBD patients compared to normal subjects, 644 μg/g (644 - 587.8 μg/g) vs 308.5 μg/g (505.4 - 233.8 μg/g), respectively. Diarrhea (n = 13, 38.4%), abdominal cramps (n = 12, 36.4%), and weight loss (n = 11, 33.3%) were the most common complaints noted in children with high fecal calprotectin levels, whereas in adults, abdominal cramps (n = 60, 51.3%), diarrhea (n = 59, 50.4%), and weight loss (n = 46, 39.3%) were the common complaints. The median fecal calprotectin levels in children already known to have IBD (n = 3) were higher than the levels noted in children with no diagnosis (n = 30); p value > 0.05. Similarly, median fecal calprotectin levels in adults with IBD (n = 28) were higher than the levels noted in patients with no specific diagnosis (n = 91), 400.7 μg/g (656.6 - 244.3 μg/g) vs 302.7 μg/g (564.6 - 206 μg/g); p value > 0.05.Conclusion: Current study affirms that the fecal calprotectin test can be used in identifying IBD patients in all age groups.

Plasma dosage of ghrelin, IGF-1, GLP-1 and leptin related to gastric emptying and esophageal pH-impedance in children with obesity.

The main aim of the study was to assess the relationship between leptin, ghrelin, insulin-like growth factor 1 (IGF-1), and glucagon-like peptide 1 (GLP-1) blood levels and gastric motility in children with obesity compared to healthy children. Secondary aims were to assess the possible association between these hormones and obesity, reflux impedance parameters, reflux symptoms, other GI disorders, and quality-of-life scores within the same groups. Children with obesity plus GERD symptoms and 2 control groups of children with obesity without GERD and healthy lean children aged 4-17years underwent an auxological evaluation, an assessment of gastro-intestinal symptoms and quality of life, hormonal dosages, and an evaluation of gastric emptying time (GET) through 13C-octanoic acid breath test. No significant association was found between hormones and gastric motility. Leptin and ghrelin levels were significantly associated with obesity parameters. No significant differences were found between GET and hormones of the patients with obesity, either with or without GERD. Although we found an association between auxological parameters and both leptin and ghrelin levels, this association did not imply an effect on the upper GI motility. Therefore, our hypothesis that alterations of these hormones in children with obesity could affect gastric emptying, triggering GERD, was not supported by our data.

Effect of Combined Heat killed Probiotic and Wheat Bran on Gastrointestinal Symptoms in Hemodialysis Children.

Background Gastrointestinal (GIT) disturbances are recorded in patients with end stage renal diseases (ESRD) frequently, killed probiotic was reported in to decrease GIT problems many other diseases ; So The aim of our study is to evaluate whether a combination of heat killed probiotic and wheat bran affect the presence and severity of gastrointestinal symptoms (GIS) in hemodialysis children Patients and methods Our study was Open label uncontrolled clinical trial conducted on 35 pediatric patients on regular hemodialysis for end stage renal disease. Every patient received one sachet of killed probiotic and wheat bran twice daily for two months. Assessment of GIT symptoms were done one month before administration of the drug, then follow them for two months during intervention then reassess the symptoms. Result We found that combined heat killed probiotic +wheat bran administration to hemodialysis children produced significant differences in urea, Hb and Po4 levels compared to baseline levels, in addition children produced highly significant decrease in all gastrointestinal symptoms (P<0.001) after 1 month, after 2 months in comparison to baseline. Conclusion We concluded that combination of heat killed probiotic and wheat bran decreases presence and severity of gastrointestinal symptoms (GIS) in hemodialysis children; thus we hypothysed that, our results could represent an important preliminary work that need further justification.

Assessment of Gastrointestinal Symptoms and Non-transferrin Bound Iron After Oral Ferrous Sulfate and Iron-enriched Aspergillus Oryzae Supplementation in Women (P24-039-19)

ObjectivesIron deficiency anemia (IDA) is a widespread nutritional deficiency. Iron supplementation with ferrous sulfate (FeSO4) is the most common strategy to treat IDA; however, the compliance with daily FeSO4 administration is poor, due to contraindicating side effects. Previously, we have reported that A. oryzae (Ultimine®; ULT) is a novel iron source. Therefore, the objective of this study was to determine the biochemical assessment, non-transferrin bound iron (NTBI) and commonly related gastrointestinal side effects to assess the safety of A. oryzae compared to FeSO4. MethodsFemale participants (n = 16) with serum ferritin concentrations 40 μg/L were randomized to a double-blind, 9-wk cross-over study with a 3-wk placebo washout period between treatments. Oral iron supplements (65 mg Fe), FeSO4 and ULT were administered for 21 consecutive days for each subject. Side effect questionnaires were collected 3d/wk over the 9-wk study period. Side effects and biochemical markers (nausea, heartburn, abdominal pain, fatigue, headache, diarrhea, constipation, oxidative stress and liver and kidney function) from iron supplementation were evaluated, along with serum iron, % transferrin saturation (TS) and NBTI 8 h curves. ResultsSerum iron, TS, and NTBI were all markedly higher with FeSO4 at each time-point from 2–8 hours (P < 0.001) compared to ULT, whereas NTBI was undetected. Among treatments, FeSO4 resulted in higher inflammation, though not statistically significant. Compliance based on returned pills was higher with ULT (97.3%) than placebo and FeSO4 (95.2% and 93.2%, respectively). Subjects taking FeSO4 reported abdominal discomfort 2% more than ULT, which was not significantly different. FeSO4 caused marginally higher incidence of combined nauseation, constipation and diarrhea when subjects were taking FeSO4 (P < 0.07). Iron status was maintained similarly by both oral iron supplements. Oxidative stress, inflammation, kidney and liver function markers were not elevated with ULT supplementation, suggesting safety of its consumption. ConclusionsBetter compliance and less gastrointestinal related side effects were reported with ULT compared to FeSO4, while maintaining normal iron status. Our data suggests ULT is a safe oral iron supplement for treatment of IDA. Funding SourcesCura Global Health, Inc.

Su1596 - Categorisation of Patients with Dyspeptic Symptoms Utilising Rome III and Rome IV or Symptom Impact as Assessed with the Validated Structured Assessment of Gastrointestinal Symptoms (SAGIS) Instrument

Su1596 - Categorisation of Patients with Dyspeptic Symptoms Utilising Rome III and Rome IV or Symptom Impact as Assessed with the Validated Structured Assessment of Gastrointestinal Symptoms (SAGIS) Instrument

Mo1118 Beneficial Effect of the Standardised Assessment of Gastrointestinal Symptoms (SAGIS) Instrument on the Time Required to Clinically Assess GI Patients in an Outpatient Environment: A Randomized Study

Mo1118 Beneficial Effect of the Standardised Assessment of Gastrointestinal Symptoms (SAGIS) Instrument on the Time Required to Clinically Assess GI Patients in an Outpatient Environment: A Randomized Study

Tu1197 Flexible Endoscopic Diverticulotomy of Diverticulum of Zenker: An Easy and Effective Technique

Background: High Resolutions Manometry (HRM) is the gold standard for the categorisation of motility disorders of the oesophagus, with achalasia as one of the most distinct manometric conditions. We aimed to compare the gastrointestinal symptom pattern and intensity in patients referred for HRM with and without a final diagnosis of achalasia utilising the recently developed SAGIS (Structured Assessment of Gastrointestinal Symptoms) instrument. Methods: Data from 50 consecutive patients referred for HRM for dysphagia were included in this study, mean age 56 years, range 17-84, 28 female. All patients had a negative upper GI endoscopy and other tests required to exclude structural abnormalities. Gastrointestinal symptoms were assessed prior to the HRM utilising the SAGIS questionnaire. Results: Based upon the Chicago Classification, 9 out of the 50 patients were diagnosed as having achalasia (6 males, 3 females). Overall, neither dysphagia nor the cumulated upper GI symptom score or scores for retrosternal discomfort were different for patients with or without achalasia (table 1). In contrast, patients with non-specific motor abnormalities had increased scores for IBS-type lower gut symptoms. Conclusions: Utilising the recently developed SAGIS instrument, patients with achalasia are not different from dysphagia patients with no/unspecific motor abnormalities of the oesophagus with regard to upper gastrointestinal symptoms. In particular, there are no differences in relation to the dysphagia or the retrosternal discomfort score. In contrast, patients with no/unspecific motor abnormalities, scored much higher for lower gastrointestinal symptoms than achalasia patients. In addition, IBS-type symptoms such as urgency to defecate are significantly increased. In patients with dysphagia, the presence of lower gut symptoms is a negative predictor for achalasia. Table 1

Tu1196 Gastrointestinal (GI) Symptoms in Patients With Dysphagia Referred for High Resolution Manometry: Presence of Lower GI Symptoms Is a Negative Predictor for Achalasia

Background: High Resolutions Manometry (HRM) is the gold standard for the categorisation of motility disorders of the oesophagus, with achalasia as one of the most distinct manometric conditions. We aimed to compare the gastrointestinal symptom pattern and intensity in patients referred for HRM with and without a final diagnosis of achalasia utilising the recently developed SAGIS (Structured Assessment of Gastrointestinal Symptoms) instrument. Methods: Data from 50 consecutive patients referred for HRM for dysphagia were included in this study, mean age 56 years, range 17-84, 28 female. All patients had a negative upper GI endoscopy and other tests required to exclude structural abnormalities. Gastrointestinal symptoms were assessed prior to the HRM utilising the SAGIS questionnaire. Results: Based upon the Chicago Classification, 9 out of the 50 patients were diagnosed as having achalasia (6 males, 3 females). Overall, neither dysphagia nor the cumulated upper GI symptom score or scores for retrosternal discomfort were different for patients with or without achalasia (table 1). In contrast, patients with non-specific motor abnormalities had increased scores for IBS-type lower gut symptoms. Conclusions: Utilising the recently developed SAGIS instrument, patients with achalasia are not different from dysphagia patients with no/unspecific motor abnormalities of the oesophagus with regard to upper gastrointestinal symptoms. In particular, there are no differences in relation to the dysphagia or the retrosternal discomfort score. In contrast, patients with no/unspecific motor abnormalities, scored much higher for lower gastrointestinal symptoms than achalasia patients. In addition, IBS-type symptoms such as urgency to defecate are significantly increased. In patients with dysphagia, the presence of lower gut symptoms is a negative predictor for achalasia. Table 1

Long term nutritional status and quality of life following major upper gastrointestinal surgery – A cross-sectional study

Major upper gastrointestinal surgery results in permanent alterations to the gastrointestinal tract, and previously been shown to impair nutritional status. The aim of this study was to assess long term nutritional status and quality of life in people having had major upper gastrointestinal surgery, and the relationship between the two measures. People having had major upper gastrointestinal surgery greater than 6 months ago were recruited. Nutrition assessment included weight, anthropometry, Subjective Global Assessment, dietary intake and assessment of gastrointestinal symptoms; quality of life was assessed using the EORTC QLQ-C30 questionnaire. Associations between nutritional status, type of surgery and quality of life were analysed. Thirty people were recruited with fourteen people showing a degree of malnutrition according to subjective global assessment. Total gastrectomy and oesophagectomy surgery resulted in significantly higher percent weight loss than those having undergone pancreaticoduodenectomy (p = 0.01). Subjective global assessment correlated with quality of life (p = 0.003). Subjective global assessment and gastrointestinal symptoms were both significant variables in explaining quality of life (p < 0.001). Nutritional status in this group was significantly compromised, and impacted on quality of life. Individualised nutrition intervention to address malnutrition and gastrointestinal symptoms should be integrated into post surgery management.

Assessment of gastrointestinal symptoms in patients with systemic sclerosis in a UK tertiary referral centre

The gastrointestinal tract (GIT) is affected in up to 90% of patients with SSc to a variable extent and severity. We aimed to establish the frequency and range of gastrointestinal (GI) symptoms in SSc patients at the Royal Free Hospital, a tertiary referral centre. A 52-item, previously validated, questionnaire capturing SSc-related gut dysfunction was given to consecutive patients with SSc attending the rheumatology outpatient department. The questionnaire assesses the 'frequency' of five categories of symptoms and their 'impact' on social functioning and emotional well-being. Patients' notes were reviewed to establish disease subtype, autoantibody profile and other internal organ involvement. We collected 402 completed questionnaires (357 females; mean age 55). Sixty-nine per cent of patients had lcSSc and 30% dcSSc with mean disease duration of 11 years. Mean questionnaire scores showed that patients have a wide range of GI symptoms. Ninety-four per cent of patients reported upper and 79% lower GI symptoms, 3% of patients reported no symptoms and 10% reported daily symptoms. There was no association between disease subtype or autoantibody profile and GI symptoms. There was a positive correlation between diarrhoea scores (high scores = best health) and pulmonary fibrosis (r = 0.134, P = 0.0068). No other association between GI symptoms and other internal organ involvement was found. GI symptoms, both upper and lower, are common in patients with SSc. Patients should be asked specifically about GI symptoms as they may be under-reported and therefore under-treated. GI focused questionnaire is an effective way to assess gut symptoms and adjust treatment.

Long-term quality-of-life assessment of gastrointestinal symptoms before and after laparoscopic Nissen fundoplication

This was a prospective quality-of-life (QoL) assessment of gastrointestinal symptoms before laparoscopic Nissen fundoplication and during the 6-year postoperative follow-up. Over a 15-month period, 35 consecutive patients with gastroesophageal reflux disease (GERD) underwent surgery after failure of medical treatment with proton pump inhibitors. QoL was assessed using the Gastrointestinal Quality of Life Index (GIQLI) preoperatively, and at 3, 6, 12, 24, 48 and 72 months postoperatively. The preoperative GIQLI score was lower than the 'normal' score (126 points), as were the scores overall and for each dimension (social integration, physical function, emotions and gastrointestinal symptoms; all P<0.001). Also, although the GIQLI increased significantly (P<0.0001) at 3, 6, 12, 24, 48 and 72 months, it remained below normal (P<0.01). The symptom score also remained below that of the normal population (57 vs 67; P<0.0001), while the percentages of patients with abdominal pain, dysphagia, modified eating habits and belching decreased non-significantly. However, GERD symptoms were significantly reduced (51% vs 4%; P=0.01), although 20% of patients started taking proton pump inhibitors again during the follow-up period. Surgery eliminated 50% of the dysphagia symptoms reported preoperatively and, after 6 years, only 8% of patients still complained of dysphagia. Patients who undergo surgery after failure of medical treatment for GERD can expect an improved QoL, although they may not be able to achieve normal levels. Preoperative symptoms should be carefully recorded in order to better inform patients of the expected outcome following surgery.

W1392 DNA Microarray SNP Analysis of Domperidone Efficacy in Patients With Gastroparesis.

Background: Few psychometrically sound patient-reported symptom scales are available for evaluating treatments for gastroparesis. The Gastroparesis Cardinal Symptom Index (GCSI) has been used extensively but it is based on a two week recall. The GCSI-Daily Diary (GCSI-DD) was developed to assess symptom severity for clinical trials and other studies in patients with gastroparesis (Revicki 2009). Prior studies have shown that the GCSI-DD was relevant to patients with symptoms of gastroparesis (Revicki 2009). Aim: This study was designed to evaluate the reliability and content validity of the GCSI-DD. Methods: A longitudinal observational study was conducted in patients with a confirmed diagnosis of gastroparesis based on gastric emptying scintigraphy from three clinical practices in United States. Patients completed the Patient Assessment of Gastrointestinal Symptoms (PAGI-SYM) and SF-36 Health Survey. Severity of gastroparesis was assessed by physicians on a 5 point scale using a Physician-rating of Patient's Gastroparesis Severity (Revicki 2003). Patients then started filling out the GCSI-DD each night. The GCSI-DD has subscale scores for Fullness/early satiety, Nausea/vomiting, and Bloating. Internal consistency reliability was evaluated using Cronbach's alpha, and validity was examined through correlations with PAGI-SYM and SF-36 scores. Results: Thirty-three patients were included in these analyses. Mean age was 40.1 (SD=15.3) years, with 85% women, and 94% Caucasian. Clinical severity of gastroparesis was 3.4 (SD=0.5; 0 to 5 scale). At baseline, Cronbach's alpha coefficients were 0.64 for Fullness/early satiety, 0.69 for Nausea/vomiting, and 0.96 for Bloating, consistent with good to excellent internal reliability. GCSI-DD total scores were significantly correlated with PAGI-SYM for Nausea/vomiting (r=0.57, p<0.01), Bloating (r=0.74, p<0.0001), Upper abdominal pain (r=0.49, p<0.01), and total scores (r=0.61, p<0.001), consistent with external validity of GCSI-DD. No significant correlations were observed between GCSI-DD and SF-36 subscale scores. Conclusions: This study provides evidence supporting the reliability and validity of the GCSI-DD in patients with gastroparesis. Together with previous extensive validation of the GCSI, this GCSI daily symptom diary has the characteristics to be a good patient reported outcome for evaluating the effectiveness of treatments in clinical trials for gastroparesis. Further research is needed on the responsiveness of the GCSI-DD to changes in clinical status with treatment.

Multicenter, Randomized, Placebo-Controlled Trial of Amitriptyline in Children With Functional Gastrointestinal Disorders

There are no prospective, multicenter, double-blind, placebo-controlled, randomized pharmacologic trials for the treatment of pain-predominant functional gastrointestinal disorders in children. The aim of this study was to evaluate the efficacy of amitriptyline in children with pain-predominant functional gastrointestinal disorders. In this multicenter placebo-controlled trial, children with irritable bowel syndrome, functional abdominal pain, or functional dyspepsia were randomized to 4 weeks of placebo or amitriptyline (10 mg/d, weight <35 kg; 20 mg/d, weight >35 kg). Assessment of gastrointestinal symptoms, psychological traits, and daily activities occurred before and after intervention. Pain was assessed daily with self-report diaries. The primary outcome was overall response to treatment (child's assessment of pain relief and sense of improvement). Secondary outcomes were effect on psychosocial traits and daily functioning. Ninety children were enrolled, and 83 completed the study (placebo, 40 children [30 girls]; drug, 43 children [35 girls]). A total of 63% of patients reported feeling better and 5% feeling worse in the amitriptyline arm compared with 57.5% feeling better and 2.5% feeling worse in the placebo arm (P = .63). Pain relief was excellent in 7% and good in 38% of children receiving placebo compared with excellent in 15% and good in 35% of children treated with amitriptyline (P = .85). Logistic regression analysis of those reporting excellent or good response versus fair, poor, or failed response showed no difference between amitriptyline and placebo (P = .83). Children who had more severe pain at baseline in both groups (P = .0065) had worse outcome. Amitriptyline reduced anxiety scores (P < .0001). Both amitriptyline and placebo were associated with excellent therapeutic response. There was no significant difference between amitriptyline and placebo after 4 weeks of treatment. Patients with mild to moderate intensity of pain responded better to treatment.