SBI in Children With d-IBS
Completed · Not applicable · Has a placebo group
Conditions studied: Irritable Bowel Syndrome
In brief
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.
Key facts
- Study ID
- NCT02609529
- Run by
- Louisiana State University Health Sciences Center in New Orleans
- People needed
- 20
- Starts
- 2015-11-01
- Expected to finish
- 2017-03-02
- Last updated by the study team
- 2017-03-09
Who can join
Age: 8 and older, up to 18. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Males and non-pregnant females between 8 years and 18 years at the time of consent.
- Able to obtain parental or legal guardian informed consent from subjects as applicable.
- d-IBS determined by ROME III criteria. A Rome III diagnosis consists of recurrent abdominal pain or discomfort at least 2days/week in the last 3 months prior to enrollment associated with two or more of the following10:
- Improvement with defecation 2. Onset associated with a change in frequency of stool 3. Onset associated with a change in form (appearance) of stool.
You may not qualify if…
- Children taking pharmacologic treatment for d-IBS will be excluded.
- Children who are unable to articulate symptoms of IBS will be excluded.
- Non-English speaking children will be excluded.
- Children with known allergy or hypersensitivity to beef or any component of SBI.
- Pregnancy.
Where it is running
- Childrens Hospital — New Orleans, Louisiana, United States
Full record on ClinicalTrials.gov
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