Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome

September 24, 2014 updated by: Cheryl Stevenson, University of Stellenbosch

Randomised Controlled Trial: Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome

In patients with IBS, will supplementation with a probiotic demonstrate symptomatic efficacy and will the probiotic influence gut microflora and thus improve clinical outcomes, as compared to no intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Conduct a study on nutrient intakes gastrointestinal microbiota and the effect of a probiotic, Lactobacillus plantarum 299v in irritable bowel syndrome patients.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6001
        • Netcare Greenacres Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fulfillment of the Rome II criteria for IBS,
  • availability of at least one colonoscopy within the last three years,
  • aged 18 or older at the time of screening,
  • provision of written informed consent,
  • commitment of availability throughout the 12 week study period.

Exclusion Criteria:

  • major abdominal surgery in the past other than other than appendectomy, caesarean section, tubal laparoscopic cholecystectomy, abdominal wall hernia repair or/and hysterectomy,
  • current use of antibiotics,
  • history of organic intestinal disease,
  • pregnant or breastfeeding mothers,
  • chronic infectious disease like HIV or tuberculosis, and
  • unable to understand English or Afrikaans.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lactobacillus plantarum 299v
Lactobacillus plantarum 299v capsules
Drug: Lactobacillus plantarum 299v
two capsules of 5 X 10 ^9 c.f.u each
Other Names:
  • Lp 299v
Other: Run in period
Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo
Other Names:
  • Run in period to baseline
Other: Wash - out period
Wash - out period following treatment phase of eight weeks
Other Names:
  • Wash - out following treatment phase of eight weeks
PLACEBO_COMPARATOR: Crytalline cellulose powder
Placebo capsule, filled with micro-crystalline cellulose powder
Other: Run in period
Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo
Other Names:
  • Run in period to baseline
Other: Wash - out period
Wash - out period following treatment phase of eight weeks
Other Names:
  • Wash - out following treatment phase of eight weeks
Drug: Placebo comparator
Micro-crystalline cellulose powder, identical taste, texture and appearance
NO_INTERVENTION: Run in period
Run in period of one to two weeks, no treatment. At baseline randomization and treatment commenced.
NO_INTERVENTION: Wash out period
Wash out period of two weeks, no treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A Change in Abdominal Pain Severity
Time Frame: Total trial period 12 weeks
The clinical severity of the IBS symptoms (pain and distension) was evaluated by the Francis Severity Score questionnaire (Francis 1997). The questionnaire is a validated tools for use in IBS. The severity score contained five questions, each given a value from 0 (no symptoms) to 100 (most severe) for measuring the severity and frequency of abdominal pain. The sum of scores of these questions was considered the severity score, with a maximum possible score of 500
Total trial period 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Stellenbosch

Collaborators

Nestlè Nutrition Institute Africa
National Research Foundation (NRF) (RSA)

Investigators

  • Principal Investigator: Cheryl Stevenson, M.Sc, Univeristy of Stellenbosch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (ESTIMATE)

June 26, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 29, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N10-08-270

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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