Probiotics in GastroIntestinal Disorders
PROGID
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
2 other identifiers
interventional
360
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2002
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 2, 2007
CompletedFirst Posted
Study publicly available on registry
August 3, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedJune 14, 2011
August 1, 2007
August 2, 2007
June 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
One year
Secondary Outcomes (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
One Year
Study Arms (3)
1
ACTIVE COMPARATORBifidobacterium infantis 35624
2
ACTIVE COMPARATORLactobacillus salivarius UCC118
3
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University College Corklead
- European Commissioncollaborator
Study Sites (1)
Cork University Hospital
Cork, Co Cork, 0, Ireland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fergus Shanahan, Prof
Cork University Hospital & University College Cork
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 2, 2007
First Posted
August 3, 2007
Study Start
January 1, 2002
Study Completion
November 1, 2007
Last Updated
June 14, 2011
Record last verified: 2007-08