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Probiotics in GastroIntestinal Disorders (PROGID)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by University College Cork.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
European Commission
Information provided by:
University College Cork
ClinicalTrials.gov Identifier:
NCT00510978
First received: August 2, 2007
Last updated: June 13, 2011
Last verified: August 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Crohn's Disease
 Biological: Bifidobacterium infantis 35624
Biological: Lactobacillus salivarius UCC118
Biological: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: One Year, Randomised, Double Blind, Placebo Controlled Trial of Probiotics, Bifidobacterium Infantis 35624 or Lactobacillus Salivarius UCC118, as Food Supplements for Maintenance of Remission in Crohn's Disease and Ulcerative Colitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University College Cork:

Primary Outcome Measures:
  • To determine whether ingestion of probiotic preparations (containing Lactobacillus salivarius subsp. salivarius UCC118 or Bifidobacterium infantis 35624) can help in the maintenance of remission of patients with Crohn's disease and ulcerative colitis [ Time Frame: One year ]

Secondary Outcome Measures:
  • Evaluation of the immunological and biochemical parameters of the immuno-inflammatory response and an assessment of the faecal flora in patients consuming the probiotic and control products [ Time Frame: One Year ]

Enrollment: 360
Study Start Date: January 2002
Estimated Study Completion Date: November 2007
Arms Assigned Interventions
Active Comparator: 1
Bifidobacterium infantis 35624
 Biological: Bifidobacterium infantis 35624
1 sachet/day for one year
Active Comparator: 2
Lactobacillus salivarius UCC118
 Biological: Lactobacillus salivarius UCC118
1 sachet per day for 1 year
Placebo Comparator: 3
Placebo
 Biological: Placebo
1 sachet per day for 1 year

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Crohn's Disease:

  • Patients must be in clinical relapse with a CDAI score >150.
  • Probiotic consumption must start within 2 weeks of commencing steroid use.
  • To achieve remission, administration of steroids to the patients must follow the guidelines: Start dose of 40 mg per day, Taper daily dose by 5 mg per week every 1-2 weeks from 40 mg to 20 mg. Reduce thereafter from 20 mg - 0 mg ensuring the dosage is reduced to 0 mg by end of week 12.
  • Patients must be taking 5-ASA.

Inclusion Criteria for Ulcerative Colitis:

  • Patients must be within one month of entering remission following a documented episode of relapse (despite the use of 5-ASA).
  • Remission is defined as patients who experience <3 bowel movements (without frank/gross blood) per day on >3 days out of 7 and are off all steroids including topical steroids.
  • Patients may be receiving treatment involving 5-ASA or 5-ASP. However, this dose may not vary during the study.

Exclusion Criteria:

  • Age - patients over 75 years will be excluded.
  • Be pregnant, or have the desire to become pregnant during the study period.
  • Patients with clinically significant immunodeficiency (quantitative immunoglobulin levels will be performed before entry to trial).
  • Patients who are considered to be poor clinical attendees or be unlikely for any reason to be able to comply with the trial.
  • Concomitant Drug usage - Patients may not be receiving any treatment with 6-Mercaptopurine, Azothioprine or cyclosporin.
  • Patients may not be receiving treatment involving experimental drugs.
  • Patients who have been on antibiotics within the previous month or who are likely to require antibiotics during the trial period will be excluded.
  • Previous surgery - patients will be excluded if the have undergone resection of more than one (1) metre of bowel in the past. Patients who have undergone less extensive surgical resection of bowel will be eligible provided there is objective (endoscopic or radiological) evidence of recurrence.
  • Malignancy or any concomitant end-stage organ disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510978

Locations
Ireland
Cork University Hospital
Cork, Co Cork, Ireland, 0
Sponsors and Collaborators
University College Cork
European Commission
Investigators
Principal Investigator: Fergus Shanahan, Prof Cork University Hospital & University College Cork
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00510978     History of Changes
Other Study ID Numbers: CT900/301/1-2, QLK1-CT-2000-00563
Study First Received: August 2, 2007
Last Updated: June 13, 2011
Health Authority: Finland: Ethics Committee
Spain: Ethics Committee

Keywords provided by University College Cork:
Inflammatory Bowel Disease IBD
Ulcerative Colitis
Crohn's disease
Probiotics
Gastrointestinal

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Digestive System Diseases
Gastrointestinal Diseases
Ulcer
 Gastroenteritis
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013