NCT00355810

Brief Summary

This randomised, double blind, cross-over study compares the effect (symptoms, fecal bacterial growth, gas production) of three weeks' treatment with lactobacillus plantarum MF 1298 with placebo in patients with irritable bowel syndrome. The results are related to dietary habits, food intolerance and food allergy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

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, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

July 19, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

July 24, 2006

Last Update Submit

July 18, 2016

Conditions

Functional Gastrointestinal DisordersIrritable Bowel Syndrome

Keywords

Probiotics

Outcome Measures

Primary Outcomes (1)

  • Satisfactory relief of abdominal symptoms

    relief of symptoms recorded on diary cards

    11 weeks

Secondary Outcomes (4)

  • Graded measurement of abdominal symptoms

    11 weeks

  • Fecal bacterial count

    11 weeks

  • Abdominal gas

    11 weeks

  • Immunological parameters

    11 weeks

Study Arms (2)

placebo followed by probiotic

EXPERIMENTAL

placebo, then washout period, then Lactobacillus plantarum MF1298

Dietary Supplement: placebo followed by Lactobacillus plantarum MF 1298

probiotic followed by placebo

EXPERIMENTAL

Lactobacillus plantarum MF1298, then washout period, then placebo

Dietary Supplement: Lactobacillus plantarum MF1298 followed by placebo

Interventions

placebo followed by Lactobacillus plantarum MF 1298DIETARY_SUPPLEMENT

placebo during 3 weeks, washout period 4 weeks, Lactobacillus plantarum MF1298 during 3 weeks

Also known as: probiotic
placebo followed by probiotic
Lactobacillus plantarum MF1298 followed by placeboDIETARY_SUPPLEMENT

Lactobacillus plantarum MF1298 during 3 weeks, washout period 4 weeks, placebo during 3 weeks

Also known as: probiotic
probiotic followed by placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Irritable bowel syndrome according to the Rome II criteria
  • regular symptoms

You may not qualify if:

  • Use of probiotics last three weeks
  • pregnancy
  • lactation
  • co-existing other gastrointestinal disorders
  • use of laxatives and antibiotics within last 5 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innlandet Hospital HF

Gjøvik, Oppland, N-2819, Norway

Location

Related Publications (2)

  • Ligaarden SC, Axelsson L, Naterstad K, Lydersen S, Farup PG. A candidate probiotic with unfavourable effects in subjects with irritable bowel syndrome: a randomised controlled trial. BMC Gastroenterol. 2010 Feb 10;10:16. doi: 10.1186/1471-230X-10-16.

    PMID: 20144246RESULT

  • Farup PG, Jacobsen M, Ligaarden SC, Rudi K. Probiotics, symptoms, and gut microbiota: what are the relations? A randomized controlled trial in subjects with irritable bowel syndrome. Gastroenterol Res Pract. 2012;2012:214102. doi: 10.1155/2012/214102. Epub 2012 Jul 31.

    PMID: 22899904RESULT

MeSH Terms

Conditions

Gastrointestinal DiseasesIrritable Bowel Syndrome

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Digestive System DiseasesColonic Diseases, FunctionalColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Per G Farup, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2006

First Posted

July 25, 2006

Study Start

January 1, 2006

Primary Completion

April 1, 2006

Study Completion

December 1, 2006

Last Updated

July 19, 2016

Record last verified: 2016-07

Locations

NO(1)