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

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

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

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Lactobacillus plantarum 299v
* Drug: Placebo comparator
* Other: Run in period
* Other: Wash - out period


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus plantarum 299v<br>Lactobacillus plantarum 299v capsules | Drug: Lactobacillus plantarum 299v<br>* two capsules of 5 X 10 ^9 c.f.u each<br>* Other names: Lp 299v;Other: Run in period<br>* Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo<br>* Other names: Run in period to baseline;Other: Wash - out period<br>* Wash - out period following treatment phase of eight weeks<br>* Other names: Wash - out following treatment phase of eight weeks;|
| Placebo Comparator: Crytalline cellulose powder<br>Placebo capsule, filled with micro-crystalline cellulose powder | Drug: Placebo comparator<br>* Micro-crystalline cellulose powder, identical taste, texture and appearance<br>Other: Run in period<br>* Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo<br>* Other names: Run in period to baseline;Other: Wash - out period<br>* Wash - out period following treatment phase of eight weeks<br>* Other names: Wash - out following treatment phase of eight weeks;|
| No Intervention: Run in period<br>Run in period of one to two weeks, no treatment. At baseline randomization and treatment commenced. | |
| No Intervention: Wash out period<br>Wash out period of two weeks, no treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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only constipation and diarrhea predominant, no mixed or alternating types