NCT01257620

Clinical Trial on the Effects of Bifidobacterium Infantis in Active Celiac Disease

Exploratory, Randomized, Double-blind, Placebo-Controlled Study on the Effects of Bifidobacterium Infantis in Active Celiac Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Bai, Julio M.D. · Individual
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 description

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).

Conditions

• Celiac Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Bifidobacterium infantis, 2 capsules (2.0E+9 CFU/capsule) 3 times/day for a total of 1.2E+10 CFU/day for 21 days.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-09-01
• Completion: 2011-12-01
• First posted: 2010-12-10
• Last updated: 2012-02-13

Locations

1 site across 1 country: Argentina