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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 4
Locations
South Africa
Study Type
Interventional
Intervention
Lactobacillus plantarum 299v
Placebo comparator
Run in period
Wash - out period
Sponsored by
University of Stellenbosch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring only constipation and diarrhea predominant, no mixed or alternating types

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Netcare Greenacres Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

No Intervention

No Intervention

Arm Label

Lactobacillus plantarum 299v

Crytalline cellulose powder

Run in period

Wash out period

Arm Description

Lactobacillus plantarum 299v capsules

Placebo capsule, filled with micro-crystalline cellulose powder

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

Wash out period of two weeks, no treatment.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 18, 2013
Last Updated
September 24, 2014
Sponsor
University of Stellenbosch
Collaborators
Nestlè Nutrition Institute Africa, National Research Foundation (NRF) (RSA)
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1. Study Identification

Unique Protocol Identification Number
NCT01886781
Brief Title
Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
Official Title
Randomised Controlled Trial: Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Stellenbosch
Collaborators
Nestlè Nutrition Institute Africa, National Research Foundation (NRF) (RSA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
Detailed Description
Conduct a study on nutrient intakes gastrointestinal microbiota and the effect of a probiotic, Lactobacillus plantarum 299v in irritable bowel syndrome patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
only constipation and diarrhea predominant, no mixed or alternating types

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus plantarum 299v
Arm Type
Experimental
Arm Description
Lactobacillus plantarum 299v capsules
Arm Title
Crytalline cellulose powder
Arm Type
Placebo Comparator
Arm Description
Placebo capsule, filled with micro-crystalline cellulose powder
Arm Title
Run in period
Arm Type
No Intervention
Arm Description
Run in period of one to two weeks, no treatment. At baseline randomization and treatment commenced.
Arm Title
Wash out period
Arm Type
No Intervention
Arm Description
Wash out period of two weeks, no treatment.
Intervention Type
Drug
Intervention Name(s)
Lactobacillus plantarum 299v
Other Intervention Name(s)
Lp 299v
Intervention Description
two capsules of 5 X 10 ^9 c.f.u each
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Intervention Description
Micro-crystalline cellulose powder, identical taste, texture and appearance
Intervention Type
Other
Intervention Name(s)
Run in period
Other Intervention Name(s)
Run in period to baseline
Intervention Description
Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo
Intervention Type
Other
Intervention Name(s)
Wash - out period
Other Intervention Name(s)
Wash - out following treatment phase of eight weeks
Intervention Description
Wash - out period following treatment phase of eight weeks
Primary Outcome Measure Information:
Title
A Change in Abdominal Pain Severity
Description
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
Time Frame
Total trial period 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Stevenson, M.Sc
Organizational Affiliation
Univeristy of Stellenbosch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Netcare Greenacres Hospital
City
Port Elizabeth
State/Province
Eastern Cape
ZIP/Postal Code
6001
Country
South Africa

12. IPD Sharing Statement

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

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