Randomised Controlled Trial: Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
Overview
- Phase
- Phase 4
- Intervention
- Lactobacillus plantarum 299v
- Conditions
- Irritable Bowel Syndrome
- Sponsor
- University of Stellenbosch
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- A Change in Abdominal Pain Severity
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Detailed Description
Conduct a study on nutrient intakes gastrointestinal microbiota and the effect of a probiotic, Lactobacillus plantarum 299v in irritable bowel syndrome patients.
Investigators
Cheryl Stevenson
Mrs
University of Stellenbosch
Eligibility Criteria
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.
Arms & Interventions
Lactobacillus plantarum 299v
Lactobacillus plantarum 299v capsules
Intervention: Lactobacillus plantarum 299v
Lactobacillus plantarum 299v
Lactobacillus plantarum 299v capsules
Intervention: Run in period
Lactobacillus plantarum 299v
Lactobacillus plantarum 299v capsules
Intervention: Wash - out period
Crytalline cellulose powder
Placebo capsule, filled with micro-crystalline cellulose powder
Intervention: Placebo comparator
Crytalline cellulose powder
Placebo capsule, filled with micro-crystalline cellulose powder
Intervention: Run in period
Crytalline cellulose powder
Placebo capsule, filled with micro-crystalline cellulose powder
Intervention: Wash - out period
Outcomes
Primary Outcomes
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