NCT01886781

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 29, 2014

Completed
Last Updated

September 29, 2014

Status Verified

September 1, 2014

Enrollment Period

2.4 years

First QC Date

June 18, 2013

Results QC Date

September 15, 2014

Last Update Submit

September 24, 2014

Conditions

Irritable Bowel Syndrome

Keywords

only constipation and diarrhea predominantno mixed or alternating types

Outcome Measures

Primary Outcomes (1)

  • 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

    Total trial period 12 weeks

Study Arms (4)

Lactobacillus plantarum 299v

EXPERIMENTAL

Lactobacillus plantarum 299v capsules

Drug: Lactobacillus plantarum 299vOther: Run in periodOther: Wash - out period

Crytalline cellulose powder

PLACEBO COMPARATOR

Placebo capsule, filled with micro-crystalline cellulose powder

Drug: Placebo comparatorOther: Run in periodOther: Wash - out period

Run in period

NO INTERVENTION

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

Wash out period

NO INTERVENTION

Wash out period of two weeks, no treatment.

Interventions

Lactobacillus plantarum 299vDRUG

two capsules of 5 X 10 \^9 c.f.u each

Also known as: Lp 299v
Lactobacillus plantarum 299v
Placebo comparatorDRUG

Micro-crystalline cellulose powder, identical taste, texture and appearance

Crytalline cellulose powder
Run in periodOTHER

Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo

Also known as: Run in period to baseline
Crytalline cellulose powderLactobacillus plantarum 299v
Wash - out periodOTHER

Wash - out period following treatment phase of eight weeks

Also known as: Wash - out following treatment phase of eight weeks
Crytalline cellulose powderLactobacillus plantarum 299v

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netcare Greenacres Hospital

Port Elizabeth, Eastern Cape, 6001, South Africa

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Jogging

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

RunningLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Results Point of Contact

Title
Cheryl Stevenson
Organization
University of Stellenbosch, South Africa
cheryl@retaildc.co.za
0827514411

Study Officials

  • Cheryl Stevenson, M.Sc

    Univeristy of Stellenbosch

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mrs

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 26, 2013

Study Start

January 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 29, 2014

Results First Posted

September 29, 2014

Record last verified: 2014-09

Locations

ZA(1)