NCT01151657

Brief Summary

The study aims to investigate the effect of probiotics on IBS-patients symptoms compared to placebo, when given for 6 months. By draw the investigators give IBS patients, in the age of 18-50 years, capsules with either probiotics or placebo. The patients are to take 2x2 capsules / day for 6 months. The patients are followed for 1 year. They are seen after 3, 6 and 12 months, and are followed by means of monthly letters. The capsules contain 3 different probiotic strains - Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 and Bifidobacterium Bb12. The dose is 2 x 109 - 10 x 109 CFU/capsule. The hypothesis is, that there is a clinical difference between the group receiving probiotics and the group receiving placebo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 28, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 25, 2011

Status Verified

January 1, 2009

Enrollment Period

2.4 years

First QC Date

June 25, 2010

Last Update Submit

October 24, 2011

Conditions

Irritable Bowel Syndrome

Keywords

IBSIrritable bowel syndromeProbioticsTreatmentAdequate relief

Outcome Measures

Primary Outcomes (1)

  • Adequate relief

    The patients are asked "In the last seven days, have you had adequate relief of your IBS symptoms?" . They are asked this question every month ( in a monthly letter) for 12 months.

    Every month for 12 months

Secondary Outcomes (1)

  • gastrointestinal symptoms

    Every month for 12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Capsules containing maltodextrin.

Dietary Supplement: Placebo

Probiotics

EXPERIMENTAL

Probiotics containing the 3 strains: Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 og Bifidobacterium Bb12 in the dose of 2 x 109 - 10 x 109 CFU/capsule. The patients are to take 2x2 capsules a day.

Dietary Supplement: Probiotics

Interventions

ProbioticsDIETARY_SUPPLEMENT

Capsules with probiotics containing the strains : Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 og Bifidobacterium Bb12. Dose/capsule : 2 x 109 - 10 x 109 CFU.

Probiotics
PlaceboDIETARY_SUPPLEMENT

Placebo capsules containing maltodextrin

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fulfill ROME III criteria
  • age 18-50 years
  • signed informed content

You may not qualify if:

  • Danger signals (fever, anaemia, weightloss, blod in stools, predisposition for CRC or IBD)
  • abnormal physical examination
  • comorbidity
  • abuse
  • lacking ability to talk and understand danish
  • pregnancy
  • For patients \> 40 years. Changed bowel habits, with duration \> 3 weeks, but \< 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit for General Practice, Department of gastroenterology, Odense University hospital

Odense, Odense, 5000, Denmark

Location

Related Publications (1)

  • Begtrup LM, de Muckadell OB, Kjeldsen J, Christensen RD, Jarbol DE. Long-term treatment with probiotics in primary care patients with irritable bowel syndrome--a randomised, double-blind, placebo controlled trial. Scand J Gastroenterol. 2013 Oct;48(10):1127-35. doi: 10.3109/00365521.2013.825314. Epub 2013 Aug 19.

    PMID: 23957590DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ove B Schaffalitzky de Muckadell, Dr.Med, Professor

    Department of gastroenterology, Odense University hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 25, 2010

First Posted

June 28, 2010

Study Start

January 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 25, 2011

Record last verified: 2009-01

Locations

DK(1)