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

• ClinicalTrials.gov Identifier: NCT01886781
• Recruitment Status: Completed
• First Posted: June 26, 2013
• Results First Posted: September 29, 2014
• Last Update Posted: September 29, 2014
• Sponsor: University of Stellenbosch
• Collaborators: Nestlè Nutrition Institute Africa; National Research Foundation (NRF) (RSA)
• Information provided by (Responsible Party): Cheryl Stevenson, University of Stellenbosch

Study Description

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 intervention.

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome	Drug: Lactobacillus plantarum 299v; Drug: Placebo comparator; Other: Run in period; Other: Wash - out period	Phase 4

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomised Controlled Trial: Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
• Study Start Date: January 2011
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. A Change in Abdominal Pain Severity [ Time Frame: Total trial period 12 weeks ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

South Africa

Netcare Greenacres Hospital

Port Elizabeth, Eastern Cape, South Africa, 6001

Sponsors and Collaborators

University of Stellenbosch

Nestlè Nutrition Institute Africa

National Research Foundation (NRF) (RSA)

Investigators

• Principal Investigator: Cheryl Stevenson, M.Sc; Univeristy of Stellenbosch

More Information

• Responsible Party: Cheryl Stevenson, Mrs, University of Stellenbosch
• ClinicalTrials.gov Identifier: NCT01886781
• Other Study ID Numbers: N10-08-270
• First Posted: June 26, 2013
• Results First Posted: September 29, 2014
• Last Update Posted: September 29, 2014
• Last Verified: September 2014

Keywords provided by Cheryl Stevenson, University of Stellenbosch:

only constipation and diarrhea predominant; no mixed or alternating types

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Syndrome; Disease; Pathologic Processes; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases