Contact information
Type
Scientific
Primary contact
Dr Lars Börjesson
ORCID ID
Contact details
Östra Sjukhuset
Department of Surgery
Gothenburg
SE 41685
Sweden
lars.g.borjesson@vgregion.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Local Ethics Committee at Gothenburg University, approved on 01/12/2003 (ref: O 644-03)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Lactobacillus plantarum 299®, Bifidobacterium Cure 21®
Primary outcome measures
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 trial start date
01/01/2006
Overall trial end date
31/05/2009
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant 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
Recruitment start date
01/01/2006
Recruitment end date
31/05/2009
Locations
Countries of recruitment
Sweden
Trial participating centre
Östra Sjukhuset
Gothenburg
SE 41685
Sweden
Sponsor information
Organisation
Probi AB (Sweden)
Sponsor details
Ideon Gamma 1
Sölvegatan 41
Lund
SE - 223 70
Sweden
probi@probi.se
Sponsor type
Industry
Website
Funders
Funder type
University/education
Funder name
Main funding:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Gothenburg University (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Supplementary funding:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Björnson Foundation (Sweden) (Research grant)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ihre Foundation (Sweden) (Research grant)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Probi AB (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary