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 ]

Subjects will come to the laboratory after an overnight fast, ingest the sugar probes, and collect all urine passed over the ensuing 24 hours into a pre-weighed container with 5 ml of 10% thymol in isopropanol. Urine will be vigorously mixed, total volume recorded, and aliquots rapidly frozen for subsequent transport and analysis. To evaluate intestinal permeability, subjects will ingest a solution containing: 5 g lactulose (Technilab, Montreal, Quebec, Canada), and 2 g mannitol (Sigma, St Louis, Missouri, USA) in 450 ml of water (osmolality approximately 1800 mOsmol/l).


Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in the cytokine profile. [ Time Frame: 21 days ]

Mononuclear cells obtained from blood will be isolated by Ficoll-Hypaque density centrifugation and resuspended in complete media/Dulbecco's modified Eagle medium. These mononuclear cells will be termed peripheral blood mononuclear cells (PBMCs). PBMCs will be incubated, nonstimulated, for 72 hours at 37°C in a 5% CO2 humidified atmosphere. Nonstimulated PBMC cytokine reflects the cytokine milieu from wich the PBMCs were originally isolated. Interleukin(IL)-10 and IL-12p40 cytokine levels will be measured using enzyme-linked immunosorbent assays.


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