Are probiotics beneficial for ulcerative colitis patients with poor pelvic pouch function?
ISRCTN | ISRCTN50513887 |
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DOI | https://doi.org/10.1186/ISRCTN50513887 |
Secondary identifying numbers | N/A |
- Submission date
- 19/01/2009
- Registration date
- 16/02/2009
- Last edited
- 16/02/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Lars Börjesson
Scientific
Scientific
Östra Sjukhuset
Department of Surgery
Gothenburg
SE 41685
Sweden
lars.g.borjesson@vgregion.se |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | Effect of probiotics (Lactobacillus plantarum 299® plus Bifidobacterium Cure 21®) or placebo on the pouch bacterial flora and immunological response patterns in poor pelvic pouch function: a randomised controlled trial |
Study objectives | The bacterial flora and immunological response patterns in pelvic pouches will be modified by supplemental probiotics. This could stabilise/improve pouch function (frequency of bowel movements, urgency, leakage etc.). |
Ethics approval(s) | Local Ethics Committee at Gothenburg University, approved on 01/12/2003 (ref: O 644-03) |
Health condition(s) or problem(s) studied | Ulcerative colitis |
Intervention | Participants are randomly allocated to the following two arms (randomisation ratio 1:1). Intervention group: Probiotics (Lactobacillus plantarum 299® [5 x 10^9 cfu] plus Bifidobacterium Cure 21® [5 x 10^9 cfu]) administrated orally (p.o.), twice a day for 3 weeks Control group: Placebo (p.o.) twice a day for 3 weeks The final clinical and laboratory examination is carried out at the end of treatment (at 3 weeks). A further evaluation will be carried out by a questionnaire 3 weeks after the end of treatment. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Lactobacillus plantarum 299®, Bifidobacterium Cure 21® |
Primary outcome measure | The following will be assessed at baseline and end of treatment (3 weeks): 1. Types of bacterial species in the pelvic pouch, analysed by non-culture dependent techniques, such as Terminal-Restriction Fragment Length Polymorphism (T-RFLP) 2. Markers of mucosal inflammation in faeces: calprotectin, lactoferrin, myeloperoxidase (MPO) and eosinophil cationic protein (ECP) 3. Inflammation of the lining of the rectum and colon, assessed by biopsies 4. Immunological response patterns, assessed by examination of leukocytes in blood samples |
Secondary outcome measures | 1. Clinical pouch function is evaluated by a questionnaire before and within 3 days from the end of treatment 2. Pouch biopsies are evaluated by standard histopathology before and within 3 days from the end of treatment |
Overall study start date | 01/01/2006 |
Completion date | 31/05/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 75 Years |
Sex | Both |
Target number of participants | 30 |
Key inclusion criteria | 1. Both males and females, age 18-75 years 2. Patient with a pelvic pouch because of ulcerative colitis. The pouch function should be inferior according to a clinical evaluation including a pouch function score. |
Key exclusion criteria | 1. Patient with a pelvic pouch, but with other diagnoses, e.g., Crohn's disease or polyposis 2. Patients with good pouch function |
Date of first enrolment | 01/01/2006 |
Date of final enrolment | 31/05/2009 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Östra Sjukhuset
Gothenburg
SE 41685
Sweden
SE 41685
Sweden
Sponsor information
Probi AB (Sweden)
Industry
Industry
Ideon Gamma 1
Sölvegatan 41
Lund
SE - 223 70
Sweden
probi@probi.se | |
Website | http://www.probi.com/ |
https://ror.org/03yf63872 |
Funders
Funder type
University/education
Main funding:
No information available
Gothenburg University (Sweden)
No information available
Supplementary funding:
No information available
Björnson Foundation (Sweden) (Research grant)
No information available
Ihre Foundation (Sweden) (Research grant)
No information available
Probi AB (Sweden)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |