SBI in Children With d-IBS

Status Completed

Clinical Trial Summary

IBS is the most common diagnosis in new patients in our pediatric gastroenterology clinic, accounting for 36 % of all new patients. Pediatric IBS patients always have a problem with defecation, characterized either as diarrhea predominant or constipation predominant. About one third of pediatric IBS subjects have d-IBS. There are no FDA approved treatments for children with d-IBS. There is evidence that diarrhea predominant irritable bowel syndrome d-IBS may be caused by a mild inflammation in the intestinal lining. Oral serum-derived bovine immunoglobulin protein isolate (SBI) is a medical food, believed to treat mild inflammation in the small intestine associated with some cases of d-IBS, especially those arising after acute gastroenteritis. It improved pain and diarrhea in adults with d-IBS. Our aim is to determine if SBI improves the number of spontaneous bowel movements in children with d-IBS.

Clinical Trial Description

The objectives of the study are to determine whether there is improvement in gastrointestinal symptoms (i.e., number of spontaneous bowel movements. abdominal pain, stool consistency, reduction in stool number, flatulence, urgency, incontinence), in laboratory parameters, and/or in psychosocial measures in subjects with d-IBS receiving 3 weeks of SBI.

This is a randomized, double-blind, placebo-controlled, weighted, pilot study evaluating effects of SBI (10 g per day), in children or adolescents with d-IBS.

The primary outcome will be change in the number of spontaneous bowel movements from the screening week compared to the final week. This information is gathered as part of the daily diary questions.

Secondary clinical outcome variables will include changes in abdominal pain, stool consistency, flatulence, urgency, and incontinence. Further clinical outcome variables will be change in number of spontaneous bowel movements during each treatment week compared to the screening week. Stool consistency will be assessed with the Bristol Stool Form Scale. Secondary laboratory outcome variables will include changes in stool calprotectin, stool lactoferrin, erythrocyte sedimentation rate, C-reactive protein, and platelet count from the screening week and final week. Secondary psychosocial outcomes will include data from Pediatric Quality of Life Inventory for Gastrointestinal Symptoms, and the Pediatric Functional Disability Index. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02609529
Study type	Interventional
Source	Louisiana State University Health Sciences Center in New Orleans
Contact
Status	Completed
Phase	N/A
Start date	November 2015
Completion date	March 2, 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03720314` - Microbiota Profiling in IBS
Recruiting	`NCT06166563` - Exercise, Irritable Bowel Syndrome and Fibromyalgia	N/A
Completed	`NCT05213910` - Study of a Management Strategy of Functional Bowel Disordes Related to Irritable Bowel Syndrome (IBS) With a Mixture of 8 Microbiotic Strains	N/A
Recruiting	`NCT05985018` - Traditional Dietary Advice Vs. Mediterranean Diet in IBS	N/A
Completed	`NCT04486469` - Efficacy of Physiotherapy Techniques on Irritable Bowel Syndrome (IBS). Pilot Study.	N/A
Completed	`NCT06407609` - Positive Outcomes of the Supplementation With Lecithin-based Delivery Form of Curcuma Longa and of Boswellia Serrata in IBS	N/A
Completed	`NCT04656730` - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas	Phase 4
Completed	`NCT04145856` - Combination of Alverine-simeticone and i3.1 Probiotic in IBS-D and IBS-M in Mexico	Phase 4
Recruiting	`NCT04138225` - The Ecological Role of Yeasts in the Human Gut
Active, not recruiting	`NCT03586622` - One Year Home Monitoring and Treatment of IBS Patients	N/A
Completed	`NCT05207618` - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant	N/A
Not yet recruiting	`NCT06369753` - Visible Abdominal Distension	N/A
Not yet recruiting	`NCT05157867` - In Vivo Effects of Amylase Trypsin Inhibitors	N/A
Not yet recruiting	`NCT05100719` - The Role of Irritable Bowel Syndrome in Lactose Intolerance (LION)	N/A
Recruiting	`NCT05001997` - Effects of Lactose-free Dairy Products on Athletes With Irritable Bowel Syndrome	N/A
Recruiting	`NCT02953171` - Probiotics in the Treatment of Irritable Bowel Syndrome	N/A
Completed	`NCT02977975` - Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome	N/A
Completed	`NCT03266068` - Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders
Completed	`NCT02980406` - The Role of FODMAPs in Upper GI Effects, Colonic Motor Activity and Gut-brain Signaling at the Behavioral Level	N/A
Completed	`NCT03318614` - Bifidobacterium Infantis M-63 Improves Mental Health in Irritable Bowel Syndrome Developed After a Major Flood Disaster	Phase 2/Phase 3