Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06861140

Exploring the Influence of Trptophan on the Treatment of Pouchitis

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pouchitis Digestive System Diseases Enteritis Gastroenteritis Gastrointestinal Diseases Ileal Diseases Ileitis Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tryptophan 25mg/kg bodyweight

Dietary Supplement

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

Placebo

Other

standard treatment of chronic pouchitis using pro- and antibiotics.

Primary outcomes

  1. Increase of the proportion of FoxP3+ CD4+ T cells in gut biopsies

    Time frame: 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 outcomes

  1. Increase of the frequency of Lactobacilli and Bifidobacilli in the gut microbiota

    Time frame: 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.

  2. Increase of 3-IPA-levels in blood and stool

    Time frame: 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.

  3. Higher rates of therapeutic response defined by PDAI

    Time frame: 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.

  4. Decreased number of prescribed antibiotics druing follow-up

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Franziska J Stallbaum, Dr. med.

CONTACT

[email protected]

040741053863

Zehra Oguz-Cöloglu

CONTACT

[email protected]

0049741053910

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study 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

Acronym: TryProPouch

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.