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Probiotics in GastroIntestinal Disorders

NCT00510978 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2011-06-14

No results posted yet for this study

Summary

All of us have millions of bacteria living in our gut. These bacteria are very important to our health providing us with protection against infections of the gut, allowing us to gain extra nutritional value from food we eat and helping our immune system. Changes in the balance of these many bacteria can make us vulnerable to infections both from within and from outside the gut. Certain bacteria may also be directly associated with some diseases of the gut. Research by doctors and scientists into relationships between the bacteria normally found in our gut and certain diseases of the gut is helping to develop food supplements and other therapies to treat these diseases.

This study involves research into the usefulness and safety of two probiotic products in maintaining remission in Crohn's disease and ulcerative colitis. Approximately 360 patients with Crohn's disease and ulcerative colitis from Ireland, Finland and Spain will be involved in the study. The yoghurts used in this study contain either Lactobacillus salivarius subsp. salivarius or Bifidobacterium infantis.

Conditions

Interventions

BIOLOGICAL

Bifidobacterium infantis 35624

1 sachet/day for one year

BIOLOGICAL

Lactobacillus salivarius UCC118

1 sachet per day for 1 year

BIOLOGICAL

Placebo

1 sachet per day for 1 year

Sponsors & Collaborators

Principal Investigators

  • Fergus Shanahan, Prof · Cork University Hospital & University College Cork

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Completion
2007-11-30

Countries

  • Ireland

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00510978 on ClinicalTrials.gov