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

University of Stellenbosch81 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

Lactobacillus plantarum 299vDRUG

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

Placebo comparatorDRUG

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

Run in periodOTHER

Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Netcare Greenacres Hospital

Port Elizabeth, Eastern Cape, South Africa

Outcomes

Primary Outcomes

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

Time frame: Total trial period 12 weeks

Data from ClinicalTrials.gov

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