SBI in Children With d-IBS
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      The objectives of the study are to determine whether there is improvement in gastrointestinal
      symptoms (i.e., number of spontaneous bowel movements. abdominal pain, stool consistency,
      reduction in stool number, flatulence, urgency, incontinence), in laboratory parameters,
      and/or in psychosocial measures in subjects with d-IBS receiving 3 weeks of SBI.

      This is a randomized, double-blind, placebo-controlled, weighted, pilot study evaluating
      effects of SBI (10 g per day), in children or adolescents with d-IBS.

      The primary outcome will be change in the number of spontaneous bowel movements from the
      screening week compared to the final week. This information is gathered as part of the daily
      diary questions.

      Secondary clinical outcome variables will include changes in abdominal pain, stool
      consistency, flatulence, urgency, and incontinence. Further clinical outcome variables will
      be change in number of spontaneous bowel movements during each treatment week compared to the
      screening week. Stool consistency will be assessed with the Bristol Stool Form Scale.
      Secondary laboratory outcome variables will include changes in stool calprotectin, stool
      lactoferrin, erythrocyte sedimentation rate, C-reactive protein, and platelet count from the
      screening week and final week. Secondary psychosocial outcomes will include data from
      Pediatric Quality of Life Inventory for Gastrointestinal Symptoms, and the Pediatric
      Functional Disability Index.
    

Intervention name(s): Medical Food; Placebo
Intervention type(s): Other; Other
Intervention description(s): Serum-derived bovine immunoglobulin protein isolate will be supplied by EnteraHealth. The product is manufactured in accordance with Good Manufacturing Practice (GMP) and U.S. Food and Drug Administration (FDA) guidelines for medical food ingredients (21 CFR Part 110). Serum-derived bovine immunoglobulin protein isolate (SBI) is generally recognized as safe (GRAS). The FDA has reviewed the safety dossier for SBI as a medical food product.
Other intervention name(s): Enteragam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Irritable Bowel Syndrome; Pediatrics; Nutrition