Are probiotics beneficial for ulcerative colitis patients with poor pelvic pouch function?

ISRCTN	ISRCTN50513887
DOI	https://doi.org/10.1186/ISRCTN50513887
Protocol serial number	N/A
Sponsor	Probi AB (Sweden)
Funders	Main funding:, Gothenburg University (Sweden), Supplementary funding:, Björnson Foundation (Sweden) (Research grant), Ihre Foundation (Sweden) (Research grant), Probi AB (Sweden)

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

Östra Sjukhuset
Department of Surgery
Gothenburg
SE 41685
Sweden

Email	lars.g.borjesson@vgregion.se

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Lactobacillus plantarum 299®, Bifidobacterium Cure 21®
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan