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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886781
• Other study ID #: N10-08-270
• Status: Completed
• Phase: Phase 4
• First received: June 18, 2013
• Last updated: September 24, 2014
• Start date: January 2011
• Est. completion date: June 2013

Study information

• Verified date: September 2014
• Source: University of Stellenbosch
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Health Research Ethics Committee, University of Stellenbosch
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Lactobacillus plantarum 299v
two capsules of 5 X 10 ^9 c.f.u each
• Placebo comparator
Micro-crystalline cellulose powder, identical taste, texture and appearance

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
• Wash - out period
Wash - out period following treatment phase of eight weeks

Locations

Country	Name	City	State
South Africa	Netcare Greenacres Hospital	Port Elizabeth	Eastern Cape

Sponsors (3)

Lead Sponsor	Collaborator
University of Stellenbosch	National Research Foundation (NRF) (RSA), Nestle Nutrition Institute Africa (NNIA)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A Change in Abdominal Pain Severity	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	Yes