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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
20
Patients who weigh less than 40 Kg will receive Serum Derived Bovine Immunoglobulin -5 g daily (2.5 g PO BID) and patients who weigh 40 Kg or more will receive Serum Derived Bovine Immunoglobulin- 10 g daily (5 g PO BID)
Matching placebo packets will be supplied and will appear identical to SBI with respect to volume, appearance and taste. Patients who weigh less than 40 Kg will take one-half packet BID (2.5 g BID) Patients who weigh 40 Kg or more will take one packet BID (5 g PO BID).
Connecticut Childrens Medical Center
Farmington, Connecticut, United States
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The ability of children to take SBI and related side effects
Time frame: Intervals from 0 to 4 weeks and from 4 to 8 weeks
Quality of Life Scores
The proportion of subjects who achieve an improvement in their symptoms at the end of different study assessment times.
Time frame: Assessed at Day 0, 4 weeks and 8 weeks
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