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The main goal of this randomized controlled clinical study is to evaluate the efficacy of an individual Ayurvedic nutritional counseling (according to tradition) compared to an individual conventional dietary advice (according to the German Nutrition Society - DGE) in patients with irritable bowel syndrome. It is to be investigated whether nutritional therapy elements, which patients can self-implement independently in the home environment, can achieve sustainable therapy effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ayurvedic nutritional counseling | Active Comparator | Patients will receive three Ayurvedic nutritional counselings (according to tradition) after 1, 3 and 8 weeks after Baseline. |
|
| Conventional nutritional counseling | Active Comparator | Patients will receive three conventional nutritional counselings (according to German Nutrition Society - DGE) after 1, 3 and 8 weeks after Baseline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ayurvedic nutritional counseling | Behavioral |
| ||
| Conventional nutritional counseling |
| Measure | Description | Time Frame |
|---|---|---|
| Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change | Change from IBS-SSS Baseline at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cohen Perceived Stress Scale (CPSS) - Change | Change from CPSS Baseline at 4 weeks, 12 weeks and 6 months | |
| Hospital Anxiety and Depression Scale (HADS-D) - Change | Change from HADS-D Baseline at 4 weeks, 12 weeks and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stool analysis: Intestinal microbiome by sequencing 16S rRNA | Baseline, 4 weeks | |
| Qualitative interviews in focus groups | Baseline, 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Michalsen, Prof. Dr. | Charité University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kliniken Essen-Mitte | Essen | Am Deimelsberg 34 A | 45276 | Germany | ||
| Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34552937 | Derived | Jeitler M, Wottke T, Schumann D, Puerto Valencia LM, Michalsen A, Steckhan N, Mittwede M, Stapelfeldt E, Koppold-Liebscher D, Cramer H, Wischnewsky M, Murthy V, Kessler CS. Ayurvedic vs. Conventional Nutritional Therapy Including Low-FODMAP Diet for Patients With Irritable Bowel Syndrome-A Randomized Controlled Trial. Front Med (Lausanne). 2021 Sep 6;8:622029. doi: 10.3389/fmed.2021.622029. eCollection 2021. |
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| Behavioral |
|
| Irritable bowel Syndrome - Quality of life (IBS-QOL) - Change | Change from IBS-QOL Baseline at 4 weeks, 12 weeks and 6 months |
| VAS: Pain, Sleep, General bothersomeness, Expectation - Change | Change from VAS Baseline at 4 weeks, 12 weeks and 6 months |
| Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) - Change | Change from IBS-SSS Baseline at 4 weeks and 6 months |
| Berlin |
| 14109 |
| Germany |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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