Pouchitis
Conditions
Keywords
Pouchitis, Antibiotics, Probiotics, Tryptophan, Metabolites
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTTryptophan 25mg/kg bodyweight
Tryptophan is supplemented during the treatment of chronic pouchitis with pro- and antibiotics
OTHERPlacebo
standard treatment of chronic pouchitis using pro- and antibiotics.
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
care providers, Investigators and Outcome Assessors are blinded.
Intervention model description
Interventional, double-blind, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pouchitis (PDAI \>= 7) * indication for the application of antibiotics and probiotics * Age \>=18 years * Informed consent
Exclusion criteria
* major surgery planned druing the intervention * high risk for malnutrition (NRS 2002 \>=3/ BMI \<18,5 kg/m\^2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase of the proportion of FoxP3+ CD4+ T cells in gut biopsies | from enrollent to end of treatment at 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increase of the frequency of Lactobacilli and Bifidobacilli in the gut microbiota | from enrollent to end of treatment at 12 weeks | 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. |
| Increase of 3-IPA-levels in blood and stool | from enrollent to end of treatment at 12 weeks | 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. |
| Higher rates of therapeutic response defined by PDAI | from enrollent to end of treatment at 12 weeks | 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. |
| Decreased number of prescribed antibiotics druing follow-up | from enrollent to end of observation at 52 weeks | 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. |
Contacts
Primary ContactFranziska J Stallbaum, Dr. med.
Backup ContactZehra Oguz-Cöloglu
Outcome results
None listed