Probiotics in GastroIntestinal Disorders (PROGID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00510978
Recruitment Status : Unknown
Verified August 2007 by University College Cork.
Recruitment status was:  Active, not recruiting
First Posted : August 3, 2007
Last Update Posted : June 14, 2011
European Commission
Information provided by:
University College Cork

Brief 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.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : January 2002
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
Biological: Placebo
1 sachet per day for 1 year

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00510978

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

Additional Information: Identifier: NCT00510978     History of Changes
Other Study ID Numbers: CT900/301/1-2
First Posted: August 3, 2007    Key Record Dates
Last Update Posted: June 14, 2011
Last Verified: August 2007

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

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