Exploring the Influence of Trptophan on the Treatment of Pouchitis

NCT ID: NCT06861140

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pouchitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional, double-blind, placebo-controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
care providers, Investigators and Outcome Assessors are blinded.

Study Groups

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Placebo

regular treatment of pouchitis with consecutive application of antibiotics and probiotics, followed by placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

standard treatment of chronic pouchitis using pro- and antibiotics.

Intervention

regular treatment of pouchitis with consecutive application of antibiotics and probiotics, additional supplementation of tryptophan (25mg/kg bodyweight)

Group Type EXPERIMENTAL

Tryptophan 25mg/kg bodyweight

Intervention Type DIETARY_SUPPLEMENT

Tryptophan is supplemented during the treatment of chronic pouchitis with pro- and antibiotics

Interventions

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Tryptophan 25mg/kg bodyweight

Tryptophan is supplemented during the treatment of chronic pouchitis with pro- and antibiotics

Intervention Type DIETARY_SUPPLEMENT

Placebo

standard treatment of chronic pouchitis using pro- and antibiotics.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samuel Huber, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinkum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik

Central Contacts

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Franziska J Stallbaum, Dr. med.

Role: CONTACT

040741053863

Zehra Oguz-Cöloglu

Role: CONTACT

0049741053910

Other Identifiers

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Intramural funding

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025-101427-BO-ff

Identifier Type: -

Identifier Source: org_study_id

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