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Protocol violations
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The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome.
The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on symptoms of irritable bowel syndrome (IBS). Fulfillment of Rome III criteria will be used as inclusion criterion. Subjective assessment of bowel symptoms, IBS-related quality of life and adequate relief will be assessed as outcome measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic low | Active Comparator | Lower dose of probiotic supplement |
|
| Placebo | Placebo Comparator |
| |
| Probiotic high | Active Comparator | Higher dose of probiotic supplement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic supplement | Dietary Supplement | A single strain probiotic supplement given at two doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in functional bowel symptoms | Validated questionnaire | 0 weeks, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | Validated questionnaire | 0 weeks, 6 weeks, 12 weeks |
| Adequate relief | Weekly question | Weekly over 3 month intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Ouwehand, PhD | Danisco | Study Chair |
| Anna Lyra, PhD | Danisco | Study Director |
| Lea Veijola, MD | Helsinki Health Centre | Principal Investigator |
| Sampo Lahtinen, PhD | Danisco | Study Chair |
| Anneli Tarpila, PhD | Danisco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herttoniemi Hospital | Helsinki | Helsinki | 00800 | Finland |
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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 |
|---|---|
| C100843 | Lacteol |
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|
| Change in faecal microbiota | Quantification of selected microbes and the intervention strain from faecal samples | 0 weeks, 6 weeks, 12 weeks |
| D004066 | Digestive System Diseases |