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| Name | Class |
|---|---|
| Nestlè Nutrition Institute Africa | OTHER |
| National Research Foundation (NRF) (RSA) | UNKNOWN |
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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.
Conduct a study on nutrient intakes gastrointestinal microbiota and the effect of a probiotic, Lactobacillus plantarum 299v in irritable bowel syndrome patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus plantarum 299v | Experimental | Lactobacillus plantarum 299v capsules |
|
| Crytalline cellulose powder | Placebo Comparator | Placebo capsule, filled with micro-crystalline cellulose powder |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus plantarum 299v | Drug | two capsules of 5 X 10 ^9 c.f.u each |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cheryl Stevenson, M.Sc | Univeristy of Stellenbosch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netcare Greenacres Hospital | Port Elizabeth | Eastern Cape | 6001 | South Africa |
Run-in phase of 1-2 weeks, then an 8 week treatment phase followed by a 2 week wash out period.
Patients were recruited at a private gastroenterology clinic in Port Elizabeth, South Africa between January 2011- June 2013,
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| ID | Title | Description |
|---|---|---|
| FG000 | Lactobacillus Plantarum 299v | Treatment Lactobacillus plantarum 299v |
| FG001 | Placebo | Controls Crytalline cellulose powder |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lactobacillus Plantarum 299v | Treatment Lactobacillus plantarum 299v |
| BG001 | Placebo | Controls Crytalline cellulose powder |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Mean | Standard Deviation | units on a scale | Total trial period 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lactobacillus Plantarum 299v | Treatment Lactobacillus plantarum 299v |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe rash | Reproductive system and breast disorders | Non-systematic Assessment | Severe rash unrelated to test product |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cheryl Stevenson | University of Stellenbosch, South Africa | 0827514411 | cheryl@retaildc.co.za |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D007590 | Jogging |
| ID | Term |
|---|---|
| D012420 | Running |
| D008124 | Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
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| Placebo comparator | Drug | Micro-crystalline cellulose powder, identical taste, texture and appearance |
|
| Run in period | Other | Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo |
|
|
| Wash - out period | Other | Wash - out period following treatment phase of eight weeks |
|
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Worsening of symptoms |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Duration of IBS (years) | Mean | Standard Deviation | years |
|
|
|
|
| 1 |
| 54 |
| 0 |
| 54 |
| EG001 | Placebo | Controls Crytalline cellulose powder | 0 | 27 | 0 | 27 |
|
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| D004066 | Digestive System Diseases |
| D055687 |
| Musculoskeletal and Neural Physiological Phenomena |
| D015444 | Exercise |
| D009043 | Motor Activity |