Condition category
Digestive System
Date applied
19/01/2009
Date assigned
16/02/2009
Last edited
16/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.probi.com/

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

Publication citations

Additional files

Editorial Notes