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| ID | Type | Description | Link |
|---|---|---|---|
| Intramural funding | Other Grant/Funding Number | I. Medizinische Klinik und Poliklinik, UKE |
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Patients with a pouch frequently suffer from chronic inflammation of the intestinal tract, called pouchitis. Pouchitis is routienly treated with repeated courses of antibiotics and probiotics, which does not stop the inflammation from recurring and exposes the patients to the risk of developing antibiotic -resistant pouchitis. Experimental data suggest that the effectiveness of the antibiotic and probiotic treatment can be prolonged by high consumption of trypotophan, an aminoacid present in everyday food. The Try Pro Pouch study aims to compare the consumption of high amounts of tryptophan against placebo in patients with pouchitis.
Participants with chronic pouchitis receive either a weight adapted supplement containing etiher trypotophan or a placebo after completing the standard treatment with antibiotics or probiotics for their pouchitis. Endoskopy will be performed, stool and blood will be sampled, symptoms will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | regular treatment of pouchitis with consecutive application of antibiotics and probiotics, followed by placebo. |
|
| Intervention | Experimental | regular treatment of pouchitis with consecutive application of antibiotics and probiotics, additional supplementation of tryptophan (25mg/kg bodyweight) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tryptophan 25mg/kg bodyweight | Dietary Supplement | Tryptophan is supplemented during the treatment of chronic pouchitis with pro- and antibiotics |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase of the proportion of FoxP3+ CD4+ T cells in gut biopsies | Biopsies of individuals receiving tryptophan or placebot will be analysed by Flow-Cytometry or sequencing. We aim to detect an lasting increase of the proportion of FoxP3+ CD4+ T cells in the mucosa of individuals receiving tryptophan, but not in those receiving placebo. | from enrollent to end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Increase of the frequency of Lactobacilli and Bifidobacilli in the gut microbiota | The microbiota composition will be analysed by 16sRNA sequencing. We aim to detect a relative increase of lactobacilli and bifidobacilli in all study participants following the consecutive treatment with anti- and probiotics. | from enrollent to end of treatment at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Franziska J Stallbaum, Dr. med. | Contact | 040741053863 | f.stallbaum@uke.de | |
| Zehra Oguz-Cöloglu | Contact | 0049741053910 | z.oguz-coeloglu@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Samuel Huber, Prof. Dr. med. | Universitätsklinkum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik | Principal Investigator |
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The IPD will not be shared without resonable request. If, after publication, researches ask for IPD for further analysis, anonymized data will shared.
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| ID | Term |
|---|---|
| D019449 | Pouchitis |
| ID | Term |
|---|---|
| D007079 | Ileitis |
| D004751 | Enteritis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D014364 | Tryptophan |
| ID | Term |
|---|---|
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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Interventional, double-blind, placebo-controlled
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care providers, Investigators and Outcome Assessors are blinded.
| Placebo | Other | standard treatment of chronic pouchitis using pro- and antibiotics. |
|
| Increase of 3-IPA-levels in blood and stool | 3-IPA will be measured by ELISA in in the blood and stool of participants receiving tryptophan or placebo. We expect greater increase of systemic 3-IPA in individuals receiving tryptophan. | from enrollent to end of treatment at 12 weeks |
| Higher rates of therapeutic response defined by PDAI | Endoscopy is performed before and after the intervention. We aim to reach better treatment response defined by lower PDAI, a histologic score of Pouchitis severity. | from enrollent to end of treatment at 12 weeks |
| Decreased number of prescribed antibiotics druing follow-up | The number of relapses, defined as repeated indication for antibiotics, during the observational follow-up will be counted. We aim to archive reduced number of antibiotic prescriptions indicated because of pouchitis in the intervention group during the one year follow-up. | from enrollent to end of observation at 52 weeks |
| D004066 |
| Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D007077 | Ileal Diseases |
| D000601 | Amino Acids, Essential |