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Completed

NCT Number: NCT01886781

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Netcare Greenacres Hospital

Port Elizabeth, Eastern Cape, 6001, South Africa

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus plantarum 299v

Drug

two capsules of 5 X 10 ^9 c.f.u each

Other names: Lp 299v

placebo comparator

Drug

Micro-crystalline cellulose powder, identical taste, texture and appearance

Run in period

Other

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

Wash - out period

Other

Wash - out period following treatment phase of eight weeks

Other names: Wash - out following treatment phase of eight weeks

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Stellenbosch

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 26, 2013
Registry last updated
Sep 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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