PedsQL™ Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in pediatric patients with functional and organic gastrointestinal diseases in comparison to healthy controls

Varni, James W.; Bendo, Cristiane Baccin; Denham, Jolanda; Shulman, Robert J.; Self, Mariella M.; Neigut, Deborah A.; Nurko, Samuel; Patel, Ashish; Franciosi, James P.; Saps, Miguel; Yeckes, Alyson; Langseder, Annette; Saeed, Shehzad Ahmed; Pohl, John F.

doi:10.1007/s11136-014-0781-x

Cited by 58 publications

(85 citation statements)

References 53 publications

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“…As already reported [1], the efficacy of this probiotic in acute diarrhea has been related to stools consistency. Rapid reduction of abdominal pain is relevant in the control of diarrhea, increasing patient’s quality of life and assuring a rapid recovery [20]. It is also of relevance the better effect of xyloglucan, in comparison with diosmectite, an adsorbent clay mineral with coating protective properties [1].…”

Section: Discussionmentioning

confidence: 99%

Xyloglucan for the treatment of acute diarrhea: results of a randomized, controlled, open-label, parallel group, multicentre, national clinical trial

et al. 2015

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BackgroundThere is a strong rationale for the use of agents with film-forming protective properties, like xyloglucan, for the treatment of acute diarrhea. However, few data from clinical trials are available.MethodsA randomized, controlled, open-label, parallel group, multicentre, clinical trial was performed to evaluate the efficacy and safety of xyloglucan, in comparison with diosmectite and Saccharomyces in adult patients with acute diarrhea due to different causes.Patients were randomized to receive a 3-day treatment. Symptoms (stools type, nausea, vomiting, abdominal pain and flatulence) were assessed by a self-administered ad-hoc questionnaire 1, 3, 6, 12, 24, 48 and 72 h following the first dose administration. Adverse events were also recorded.ResultsA total of 150 patients (69.3 % women and 30.7 % men, mean age 47.3 ± 14.7 years) were included (n = 50 in each group). A faster onset of action was observed in the xyloglucan group compared with the diosmectite and S. bouliardii groups. At 6 h xyloglucan produced a statistically significant higher decrease in the mean number of type 6 and 7 stools compared with diosmectite (p = 0.031). Xyloglucan was the most efficient treatment in reducing the percentage of patients with nausea throughout the study period, particularly during the first hours (from 26 % at baseline to 4 % after 6 and 12 h). An important improvement of vomiting was observed in all three treatment groups.Xyloglucan was more effective than diosmectite and S. bouliardii in reducing abdominal pain, with a constant improvement observed throughout the study. The clinical evolution of flatulence followed similar patterns in the three groups, with continuous improvement of the symptom. All treatments were well tolerated, without reported adverse events.ConclusionsXyloglucan is a fast, efficacious and safe option for the treatment of acute diarrhea.Trial registrationEudraCT number 2014-001814-24 (date: 2014-04-28)ISRCTN number: 90311828

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Section: Discussionmentioning

confidence: 99%

Xyloglucan for the treatment of acute diarrhea: results of a randomized, controlled, open-label, parallel group, multicentre, national clinical trial

et al. 2015

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“…16 The Pediatric Quality of Life Generic Core Scales overall score assesses health-related quality of life of children. 17 The Symptom Checklist-90R was used to measure parental somatic focus. 18 …”

Section: Methodsmentioning

confidence: 99%

Psyllium Fiber Reduces Abdominal Pain in Children With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial

Shulman

Hollister

Cain

et al. 2017

Clinical Gastroenterology and Hepatology

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BACKGROUND & AIMS We sought to determine the efficacy of psyllium fiber treatment on abdominal pain and stool patterns in children with irritable bowel syndrome (IBS). We evaluated effects on breath hydrogen and methane production, gut permeability, and microbiome composition. We also investigated whether psychological characteristics of children or parents affected the response to treatment. METHODS We performed a randomized, double-blind trial of 103 children (mean age, 13 ± 3 y) with IBS seen at primary or tertiary care settings. After 2 weeks on their habitual diet, children began an 8-day diet excluding carbohydrates thought to cause symptoms of IBS. Children with ≥75% improvement in abdominal pain were excluded (n = 17). Children were assigned randomly to groups given psyllium (n = 37) or placebo (maltodextrin, n = 47) for 6 weeks. Two-week pain and stool diaries were compared at baseline and during the final 2 weeks of treatment. We assessed breath hydrogen and methane production, intestinal permeability, and the composition of the microbiome before and after administration of psyllium or placebo. Psychological characteristics of children were measured at baseline. RESULTS Children in the psyllium group had a greater reduction in the mean number of pain episodes than children in the placebo group (mean reduction of 8.2 ± 1.2 after receiving psyllium vs mean reduction of 4.1 ± 1.3 after receiving placebo; P = .03); the level of pain intensity did not differ between the groups. Psychological characteristics were not associated with response. At the end of the study period, the percentage of stools that were normal (Bristol scale scores, 3–5), breath hydrogen or methane production, intestinal permeability, and microbiome composition were similar between groups. CONCLUSIONS Psyllium fiber reduced the number of abdominal pain episodes in children with IBS, independent of psychological factors. Psyllium did not alter breath hydrogen or methane production, gut permeability, or microbiome composition. ClinicalTrials.gov no: NCT00526903.

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“…YouGov was contracted to select participants from among their panel that age, sex, and race/ethnicity matched the overall patient sample for the larger field test study (11). In addition to completing the PedsQL Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales, parents completed the PedsQL Family Information Form, which included a question on whether their child had a chronic health condition.…”

Section: Healthy Controls Samplementioning

confidence: 99%

Pediatric Functional Constipation Gastrointestinal Symptom Profile Compared With Healthy Controls

Varni

Nurko

Shulman

et al. 2015

J. pediatr. gastroenterol. nutr.

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PedsQL™ Gastrointestinal Symptoms Scales and Gastrointestinal Worry Scales in pediatric patients with functional and organic gastrointestinal diseases in comparison to healthy controls

Abstract: The PedsQL™ Gastrointestinal Symptoms and Worry Scales may be utilized as common metrics across pediatric patient groups with FGIDs and organic GI diseases and healthy samples to measure GI-specific symptoms in clinical research and practice.

Cited by 58 publications

References 53 publications

Xyloglucan for the treatment of acute diarrhea: results of a randomized, controlled, open-label, parallel group, multicentre, national clinical trial

Xyloglucan for the treatment of acute diarrhea: results of a randomized, controlled, open-label, parallel group, multicentre, national clinical trial

Psyllium Fiber Reduces Abdominal Pain in Children With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial

Pediatric Functional Constipation Gastrointestinal Symptom Profile Compared With Healthy Controls

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