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

Stellenbosch University (SU)

Status and phase: Completed; Phase 4

Conditions: Irritable Bowel Syndrome

Treatments: Other: Wash - out period; Drug: Placebo comparator; Other: Run in period; Drug: Lactobacillus plantarum 299v

Study type: Interventional

Funder types: Other

Identifiers

NCT01886781

N10-08-270

Details and patient eligibility

About

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.

Full description

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

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 4 patient groups, including a placebo group

Lactobacillus plantarum 299v

Experimental group

Description:

Lactobacillus plantarum 299v capsules

Treatment:

Other: Run in period

Drug: Lactobacillus plantarum 299v

Other: Wash - out period

Crytalline cellulose powder

Placebo Comparator group

Description:

Placebo capsule, filled with micro-crystalline cellulose powder

Treatment:

Other: Run in period

Other: Wash - out period

Drug: Placebo comparator

Run in period

No Intervention group

Description:

Run in period of one to two weeks, no treatment. At baseline randomization and treatment commenced.

Wash out period

No Intervention group

Description:

Wash out period of two weeks, no treatment.