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| Name | Class |
|---|---|
| Clinical Trials Unit University of Bern | UNKNOWN |
| University of Bern | OTHER |
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In this study the intestinal microbiome and metabolic profiles of patients with inflammatory bowel disease will be determined upon probiotic intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | 8 week probiotic supplementation, followed by 6 weeks wash-out and 8 weeks oberservation |
|
| Observation | Other | 8 week observation, followed by 6 weeks washout and 8 week probiotic supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Formula | Other | multi-strain probiotics |
| |
| Observation |
| Measure | Description | Time Frame |
|---|---|---|
| abundance of specific bacteria | operational taxonomic units (OTC) presence of total counts at T0, T1,T2,T3 | 22 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| microbiome analysis | diversity (Shannon Index) and composition (beta diversity metrics (Bray-Curtis dissimilarity)) at T0,T1,T2,T3 | 22 weeks |
| clinical response | clinical activity scores: ΔPUCAI for UC, ΔPCDAI for CD at T0,T1,T2,T3 |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life in 9 -17 years of age | Impact III score at T0,T1,T2,T3 | 22 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christiane Sokollik, Prof | Contact | +41 31 632 21 11 | christiane.sokollik@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Christiane Sokollik, Prof | Division of Paediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics, Inselspital, Bern University Hospital, University of Bern, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inselspital, Universitätsspital Bern Kinderklinik | Recruiting | Bern | Switzerland |
Individual participant data that underlie the results reported, after deidentification
Immediately following publication, ending 36 months following article publication
Investigators whose proposed use of the data has been approved by an independent review committe identified for this purpose
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| Other |
Observation |
|
| 22 weeks |
| laboratory response - local | fecal calprotection at T0,T1,T2,T3 | 22 weeks |
| laboratory response - systemic | Composite assessment of C-reactive protein, thrombocytes and ESR at T0,T1,T2,T3 | 22 weeks |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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