Irritable Bowel Syndrome
Conditions
Keywords
only constipation and diarrhea predominant, no mixed or alternating types
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.
Interventions
two capsules of 5 X 10 \^9 c.f.u each
DRUGPlacebo comparator
Micro-crystalline cellulose powder, identical taste, texture and appearance
OTHERRun 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
OTHERWash - out period
Wash - out period following treatment phase of eight weeks
Sponsors
Nestlè Nutrition Institute Africa
National Research Foundation (NRF) (RSA)
University of Stellenbosch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A Change in Abdominal Pain Severity | 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 |
Countries
South Africa
Participant flow
Recruitment details
Patients were recruited at a private gastroenterology clinic in Port Elizabeth, South Africa between January 2011- June 2013,
Pre-assignment details
Run-in phase of 1-2 weeks, then an 8 week treatment phase followed by a 2 week wash out period.
Participants by arm
| Arm | Count |
|---|---|
| Lactobacillus Plantarum 299v Treatment Lactobacillus plantarum 299v | 54 |
| Placebo Controls Crytalline cellulose powder | 27 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 0 |
| Overall Study | Protocol Violation | 5 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
| Overall Study | Worsening of symptoms | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | Lactobacillus Plantarum 299v |
|---|---|---|---|
| Age, Continuous | 47.27 years STANDARD_DEVIATION 12.15 | 47.86 years STANDARD_DEVIATION 13.03 | 48.15 years STANDARD_DEVIATION 13.48 |
| Body Mass Index | 28.88 kg/m^2 STANDARD_DEVIATION 7.74 | 28.85 kg/m^2 STANDARD_DEVIATION 7.32 | 28.83 kg/m^2 STANDARD_DEVIATION 7.12 |
| Duration of IBS (years) | 10.05 years STANDARD_DEVIATION 9.36 | 9.74 years STANDARD_DEVIATION 10 | 9.58 years STANDARD_DEVIATION 10.32 |
| Region of Enrollment South Africa | 27 participants | 81 participants | 54 participants |
| Sex: Female, Male Female | 27 Participants | 79 Participants | 52 Participants |
| Sex: Female, Male Male | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 27 |
| serious Total, serious adverse events | 1 / 54 | 0 / 27 |
Outcome results
Primary
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
Time frame: Total trial period 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lactobacillus Plantarum 299v | A Change in Abdominal Pain Severity | Baseline | 259.66 units on a scale | Standard Deviation 106.9 |
| Lactobacillus Plantarum 299v | A Change in Abdominal Pain Severity | End of treatment at week 8 | 199.13 units on a scale | Standard Deviation 119.7 |
| Lactobacillus Plantarum 299v | A Change in Abdominal Pain Severity | Change | 60.53 units on a scale | Standard Deviation 12.8 |
| Placebo | A Change in Abdominal Pain Severity | Baseline | 256.04 units on a scale | Standard Deviation 104.27 |
| Placebo | A Change in Abdominal Pain Severity | End of treatment at week 8 | 201.98 units on a scale | Standard Deviation 97.44 |
| Placebo | A Change in Abdominal Pain Severity | Change | 54.06 units on a scale | Standard Deviation 6.83 |
Comparison: An intention-to -treat (ITT) analysis was performed on all patients who underwent randomization (n = 81). The results of the ITT analysis are presented. Changes in Severity Score was examined using the mixed model for analysis of variance to account for missing data. This model used group (treatment vs control) \& time as factors.p-value: <0.05Mixed Models Analysis