Effect of Colostrum on the Symptoms and Mucosal Permeability in Patients with Irritable Bowel Syndrome: A Randomized Placebo-controlled Study

Abstract

istration of bovine colostrum could relieve all symptoms of IBS (using several scoring systems to monitor IBS), and could lead to a decrease in endotoxin levels in patients with IBS (by measuring the endotoxin level before and after administration). This study was a prospective, double-blind, randomized, placebo-controlled trial to analyze the efficacy of bovine colostrum. Patients with IBS (aged, 18−80 years) were voluntarily recruited. They were selected according to the ROME III criteria, which was the occurrence of recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with 2 or more of the following: (1) relieved with defecation; (2) onset associated with a change in frequency of stool; (3) onset associated with a change in form or appearance of stool. 11 Patients were randomly classified to either the colostrum or placebo group. A sample of bovine colostrum (15 mL; MuKoBa TM , Seoul, Korea) was orally administered once daily before breakfast. All the physical characteristics of bovine colostrum (e.g., smell, color, taste, volume, and packaging) were indistinguishable from the placebo (artificial milk). The 8-week study included a 4-week treatment period and a 4-week follow-up observation period without treatment. Clinic visits were conducted at weeks 0, 4, and 8, while phone interviews were performed weekly. Three scoring systems of IBS were used for the evaluation of symptom relief to measure the primary efficacy of colostrum. The first scoring index was assessed by using the IBS Global Improvement Scale (GIS) with the patients' rating their overall satisfaction with their IBS treatment on a 7-point Likert scale, ranging from "very unsatisfied" to "very satisfied". 12 Data were collected weekly by using an interactive voice-response telephone-based system. The second scoring index used was the Gas-trointestinal Symptom Rating Scale (GSRS-IBS), which was a short and user-friendly instrument with excellent psycho