Exploring the Influence of Trptophan on the Treatment of Pouchitis

Not Applicable

Not yet recruiting

• Conditions: Pouchitis

• Registration Number: NCT06861140
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-23
• Study First Submitted QC: 2025-03-01
• Last Update Submitted: 2025-03-01
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Study Start: 2025-04-01
• Primary Completion: 2027-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.