Diarrhea Predominant Irritable Bowel Syndrome Clinical Trial
Official title:
Safety and Tolerability of Serum-Derived Bovine Immunoglobulin in Children With Diarrhea-Predominant Irritable Bowel Syndrome
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.
The study will consist of four phases:
Screening Phase: screen the patients for 2 weeks prior to enrollment in the study to
establish objective criteria of disease presence and severity. Patients will maintain a daily
symptom dairy. At the end of screening phase, we will calculate their quality of life and
symptom severity scores based on the information provided by the patients and their family.
Patients with an average score of 1 or greater over 14 days for abdominal pain and stool
consistency will be selected for the open label trial of SBI.
Open Label Treatment Phase: patients enrolled will receive 4 weeks of SBI along with QOL
questionnaires to complete. If the patient's global assessment is that they have improved, or
if review of their diaries shows an improvement in symptom severity scores (decrease in
symptom severity score by > 30% from baseline), they will be eligible for the randomization
phase.
Patients, who do not have any improvements during the first 4 weeks of SBI therapy, will not
be randomized. If non-responders have worsening of symptoms, they will be prescribed rescue
medications as per standard of care. If non-responders choose to continue to take SBI, they
will be so allowed.
Randomization Phase: Patients who qualify for this phase will be randomized either to SBI or
placebo. They will take their medication for 4 more weeks and complete their questionnaires,
symptom as well as QOL. After this 4 week phase all patients will be offered the Open Label
Extension Phase.
Open Label Extension Phase: All patients who enter this phase will be treated with SBI for
another 16 weeks.
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