Clinical Trial: Clinical Trial on the Effects of Bifidobacterium Infantis in Active Celiac Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Exploratory, Randomized, Double-blind, Placebo-Controlled Study on the Effects of Bifidobacterium Infantis in Active Celiac Disease
Brief Summary: This exploratory study has been designed to determine the effect of the probiotic Bifidobacterium infantis vs. placebo orally administered over a period of 3 weeks on clinical features, Quality of Life parameters (QoL), intestinal permeability and inflammatory markers of patients having positive serological evidences of Celiac Disease.
Detailed Summary:
Objective: This exploratory study has been designed to determine the effect of the probiotic Bifidobacterium infantis vs. placebo orally administered over a period of 3 weeks on clinical features, Quality of Life parameters (QoL), intestinal permeability and inflammatory markers of patients having serological evidences of CD (positive serological markers). The testing period will be approximately three weeks between the results of serological testing and before the intestinal biopsy procedure during which time subjects are consuming a gluten-containing diet.
Study Design: A 3-weeks duration, placebo-controlled, double-blind, randomized study plan in ambulatory (non-hospitalized outpatients) patients, with 2 parallel groups. Treatment arms will be as follows:
A). Placebo 2 capsules 3 times daily (morning, evening and night).
B). Probiotics (Bifidobacterium infantis) 2 capsules 3 times per day (morning, evening and night).
Sponsor: Bai, Julio M.D.
Current Primary Outcome: Intestinal permeability changes [ Time Frame: 21 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Changes in the cytokine profile. [ Time Frame: 21 days ]
Original Secondary Outcome: Same as current
Information By: Bai, Julio M.D.
Dates:
Date Received: December 8, 2010
Date Started: December 2010
Date Completion:
Last Updated: February 10, 2012
Last Verified: February 2012