Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate if low-FODMAP (Fermented Oligo-, Di-, Monosaccharides And Polyols) rye bread is better tolerated in irritable bowel syndrome than commonly available traditional rye bread higher in FODMAP carbohydrates. The study also aims to investigate patients' compliance to rye bread regimen, potential changes is gut microbiota and hydrogen production during the test periods (a marker of large bowel fermentation of poorly absorbed carbohydrates).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional rye bread | Active Comparator | As part of habitual diet participants are expected to consume 100-200 grams of traditional Finnish rye bread daily |
|
| Low-FODMAP rye bread | Experimental | As part of habitual diet participants are expected to consume 100-200 grams of low-FODMAP rye bread daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional Finnish rye bread | Other |
| ||
| Low FODMAP rye bread |
| Measure | Description | Time Frame |
|---|---|---|
| Change is IBS symptoms by using IBS-SSS questionaire | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| IBS quality of life by using IBS QoL questionnaire | 4 weeks | |
| Changes in specific IBS symptoms measured by 100 mm VAS scale | 4 weeks | |
| Changes is intestinal microbiota evaluated by fecal samples |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aava Medical Centre | Helsinki | Helsinki | 00100 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32153925 | Derived | Laatikainen R, Jalanka J, Loponen J, Hongisto SM, Hillila M, Koskenpato J, Korpela R, Salonen A. Randomised clinical trial: effect of low-FODMAP rye bread versus regular rye bread on the intestinal microbiota of irritable bowel syndrome patients: association with individual symptom variation. BMC Nutr. 2019 Mar 6;5:12. doi: 10.1186/s40795-019-0278-7. eCollection 2019. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 26, 2016 | |
| Reset | Nov 14, 2016 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 26, 2016 | Nov 14, 2016 |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D053560 | Ichthyosis Bullosa of Siemens |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
| 4 weeks |
| Changes in hydrogen excretion evaluated by 6 hours breath test after standard rye bread breakfast | 4 weeks |
| D007057 | Ichthyosis |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D007232 | Infant, Newborn, Diseases |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |