Celiac Disease Clinical Trial
Official title:
Exploratory, Randomized, Double-blind, Placebo-Controlled Study on the Effects of Bifidobacterium Infantis in Active Celiac Disease
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.
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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