Status:
COMPLETED
Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
Lead Sponsor:
University of Stellenbosch
Collaborating Sponsors:
Nestlè Nutrition Institute Africa
National Research Foundation (NRF) (RSA)
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 inter...
Detailed Description
Conduct a study on nutrient intakes gastrointestinal microbiota and the effect of a probiotic, Lactobacillus plantarum 299v in irritable bowel syndrome patients.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01886781
Start Date
January 1 2011
End Date
June 1 2013
Last Update
September 29 2014
Active Locations (1)
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1
Netcare Greenacres Hospital
Port Elizabeth, Eastern Cape, South Africa, 6001