Clinical Trial on the Effects of Bifidobacterium Infantis in Active Celiac Disease
NCT01257620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2012-02-13
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
The National Institute of Probiotics
collaborator OTHER -
Bai, Julio M.D.
lead INDIV
Principal Investigators
-
Julio C Bai, M.D. · Dr. C. Bonorino Udaondo Gastroenterology Hospital
-
Edgardo Smecuol, M.D. · Dr. C. Bonorino Udaondo Gastroenterology Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-12-31
- Primary Completion
- 2011-09-30
- Completion
- 2011-12-31
Countries
- Argentina
Study Locations
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