Phase 4
N=81
Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01886781 ↗Enrolled (actual)
81
Serious AEs
1.2%
Results posted
Sep 2014
Primary outcome: Primary: A Change in Abdominal Pain Severity — 259.66; 256.04; 199.13; 201.98 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lactobacillus plantarum 299v (Drug); Placebo comparator (Drug); Run in period (Other); Wash - out period (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Stellenbosch
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY A Change in Abdominal Pain Severity |
259.66; 256.04; 199.13; 201.98; 60.53; 54.06 | <0.05 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01886781). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.