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

Phase 4

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Lactobacillus plantarum 299v; Drug: Placebo comparator; Other: Run in period; Other: Wash - out period

• Registration Number: NCT01886781
• Lead Sponsor: University of Stellenbosch

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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-26
• Status Verified: 2014-09
• Results First Submitted: 2014-09-15
• Results First Submitted QC: 2014-09-24
• Last Update Submitted: 2014-09-24
• Results First Posted: 2014-09-29
• Last Update Posted: 2014-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus plantarum 299v	Lactobacillus plantarum 299v	Lactobacillus plantarum 299v capsules
Crytalline cellulose powder	Wash - out period	Placebo capsule, filled with micro-crystalline cellulose powder
Lactobacillus plantarum 299v	Run in period	Lactobacillus plantarum 299v capsules
Lactobacillus plantarum 299v	Wash - out period	Lactobacillus plantarum 299v capsules
Crytalline cellulose powder	Run in period	Placebo capsule, filled with micro-crystalline cellulose powder
Crytalline cellulose powder	Placebo comparator	Placebo capsule, filled with micro-crystalline cellulose powder

Primary Outcome Measures

Name	Time	Method
A Change in Abdominal Pain Severity	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

Trial Locations

Locations (1)

Netcare Greenacres Hospital; 🇿🇦 Port Elizabeth, Eastern Cape, South Africa