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Bifidobacterium Infantis NLS Super Strain for Celiac Disease Patients on a Gluten-free Diet With Persistent Gastrointestinal Symptoms

NCT03271138 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-08-24

No results posted yet for this study

Summary

The primary purpose of this randomized, double-blinded, placebo-controlled, crossover clinical trial is to evaluate the efficacy of dietary supplementation with Bifidobacterium infantis NLS super strain among celiac disease patients on a gluten-free who have persistent gastrointestinal symptoms.

Conditions

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium infantis NLS super strain (Natren LIFE START®2)

2 capsules, 3 times per day, for daily total of 12x10\^9 CFU Bifidobacterium infantis NLS super strain

OTHER

Placebo

2 capsules, 3 times per day, containing rice flour, hydroxypropyl and methylcellulose

Sponsors & Collaborators

  • Dr. C. Bonorino Udaondo Gastroenterology Hospital

    collaborator OTHER_GOV

  • Research Institute, Universidad del Salvador

    collaborator UNKNOWN

  • Consejo de Investigaciones en Salud, Ministerio de Salud, Gobierno Autónomo de Buenos Aires

    collaborator UNKNOWN

  • Global Institute of Probiotics

    lead OTHER

Principal Investigators

  • Edgardo Smecuol, MD · Dr. C. Bonorino Udaondo Gastroenterology Hospital

  • Julio C Bai, MD · Dr. C. Bonorino Udaondo Gastroenterology Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-21
Primary Completion
2017-12-07
Completion
2017-12-07

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Diseases

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 NCT03271138 on ClinicalTrials.gov