Exploring the Influence of Trptophan on the Treatment of Pouchitis

NCT06861140 | Not Yet Recruiting

• 2 other identifiers: 2025-101427-BO-ffIntramural funding
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pouchitis

Keywords

Pouchitis; Antibiotics; Probiotics; Tryptophan; Metabolites

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Increase of the frequency of Lactobacilli and Bifidobacilli in the gut microbiota

  from enrollent to end of treatment at 12 weeks

• Increase of 3-IPA-levels in blood and stool

  from enrollent to end of treatment at 12 weeks

• Higher rates of therapeutic response defined by PDAI

  from enrollent to end of treatment at 12 weeks

• Decreased number of prescribed antibiotics druing follow-up

  from enrollent to end of observation at 52 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Intervention

EXPERIMENTAL

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

Dietary Supplement: Tryptophan 25mg/kg bodyweight

Interventions

Tryptophan 25mg/kg bodyweight DIETARY_SUPPLEMENT

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

Intervention

Placebo OTHER

standard treatment of chronic pouchitis using pro- and antibiotics.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pouchitis (PDAI \>= 7)
• indication for the application of antibiotics and probiotics
• Age \>=18 years
• Informed consent

You may not qualify if:

• major surgery planned druing the intervention
• high risk for malnutrition (NRS 2002 \>=3/ BMI \<18,5 kg/m\^2)

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

MeSH Terms

Conditions

Pouchitis

Interventions

Tryptophan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Samuel Huber, Prof. Dr. med.

  Universitätsklinkum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Franziska J Stallbaum, Dr. med.

CONTACT

040741053863; f.stallbaum@uke.de

Zehra Oguz-Cöloglu

CONTACT

0049741053910; z.oguz-coeloglu@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: care providers, Investigators and Outcome Assessors are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, double-blind, placebo-controlled

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 6, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share