Safety and Tolerability of Serum Derived Bovine Immunoglobulin in Children With Diarrhea Predominant IBS
Completed · Not applicable · Has a placebo group
Conditions studied: Diarrhea Predominant Irritable Bowel Syndrome
In brief
This study is being conducted to see if serum-derived bovine immunoglobulin/protein isolate (SBI) is safe and well tolerated in pediatric patients with IBS-D. Main Hypothesis :Pediatric patients with IBS-D, who take SBI, will have no significant adverse events at 4 and 8 weeks and their quality of life will be better than the patients who receive placebo.
Key facts
- Study ID
- NCT02358694
- Run by
- Connecticut Children's Medical Center
- People needed
- 20
- Starts
- 2014-06-15
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2019-02-18
Who can join
Age: 8 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female patients > 8 years of age and < 18 years of age
- Patients with a diagnosis of IBS-D as per Rome III criteria
- Patients with normal laboratory work up (CBC, ESR, CRP, amylase, lipase, celiac panel, fecal occult blood)
- Patients with normal fecal calprotectin and lactose hydrogen breath test
- Patients off motility drugs, NSAIDs for at least 2 weeks prior to enrollment in the study
- Ability to complete the study
- Patients on stable doses or other medications for at least 4 weeks prior to enrollment
You may not qualify if…
- Patients with h/o other GI, hepatic, renal, cardiovascular, neurologic or hematological disorder
- Patients with family history of inflammatory bowel disease
- Patients with history of abdominal surgery
- Patient with history of drug or alcohol abuse
- Patient with a history of allergy to study related products (e.g. beef)
- Use of probiotics in the previous month
- Patients who used SBI in the past
- Patients with soy allergy/sensitivity
Where it is running
- Connecticut Childrens Medical Center — Farmington, Connecticut, United States
Full record on ClinicalTrials.gov
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