Safety and Tolerability of Serum Derived Bovine Immunoglobulin in Children With Diarrhea Predominant IBS
Condition: Diarrhea Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Serum-Derived Bovine Immunoglobulin; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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).
Other intervention name(s): SBI; Entera
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: IBS; IBS-D; SBI