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

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01257620 on ClinicalTrials.gov