Exploring the Influence of Trptophan on the Treatment of Pouchitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tryptophan 25mg/kg bodyweight, Placebo.
- Who it may be relevant to
- Registry conditions: Pouchitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Untersuchung Des Einflusses Einer Tryptophanreichen Diät Auf Das Therapeutische Potential Von Probiotika Nach Antibiotischer Therapie Bei Chronischer Pouchitis (Try Pro Pouch). Eine Prospektive Randomisierte Kontrollierte Doppelblinde Interventionsstudie
Overview
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 supplement Tryptophan 25mg/kg bodyweight
Tryptophan is supplemented during the treatment of chronic pouchitis with pro- and antibiotics - Other Placebo
standard treatment of chronic pouchitis using pro- and antibiotics.
Primary outcome measures
- Increase of the proportion of FoxP3+ CD4+ T cells in gut biopsies [Time frame: from enrollent to end of treatment at 12 weeks]
Secondary outcome measures (4)
- Increase of the frequency of Lactobacilli and Bifidobacilli in the gut microbiota [Time frame: from enrollent to end of treatment at 12 weeks]
- Increase of 3-IPA-levels in blood and stool [Time frame: from enrollent to end of treatment at 12 weeks]
- Higher rates of therapeutic response defined by PDAI [Time frame: from enrollent to end of treatment at 12 weeks]
- Decreased number of prescribed antibiotics druing follow-up [Time frame: from enrollent to end of observation at 52 weeks]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06861140 · 2025-101427-BO-ff · Intramural funding