Exploring the Influence of Trptophan on the Treatment of Pouchitis (TryProPouch)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pouchitis
• Intervention / Treatment: Other: Placebo; Dietary supplement: Tryptophan 25mg/kg bodyweight

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Franziska J Stallbaum, Dr. med.; Phone Number: 040741053863; Email: f.stallbaum@uke.de
• Study Contact Backup: Name: Zehra Oguz-Cöloglu; Phone Number: 0049741053910; Email: z.oguz-coeloglu@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; regular treatment of pouchitis with consecutive application of antibiotics and probiotics, followed by placebo.	Other: Placebo; standard treatment of chronic pouchitis using pro- and antibiotics.
Experimental: Intervention; regular treatment of pouchitis with consecutive application of antibiotics and probiotics, additional supplementation of tryptophan (25mg/kg bodyweight)	Dietary supplement: Tryptophan 25mg/kg bodyweight; Tryptophan is supplemented during the treatment of chronic pouchitis with pro- and antibiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase of the frequency of Lactobacilli and Bifidobacilli in the gut microbiota	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.	from enrollent to end of treatment at 12 weeks
Increase of 3-IPA-levels in blood and stool	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.	from enrollent to end of treatment at 12 weeks
Higher rates of therapeutic response defined by PDAI	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.	from enrollent to end of treatment at 12 weeks
Decreased number of prescribed antibiotics druing follow-up	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.	from enrollent to end of observation at 52 weeks

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Samuel Huber, Prof. Dr. med., Universitätsklinkum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: February 23, 2025
• First Submitted That Met QC Criteria: March 1, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Probiotics; Antibiotics; Metabolites; Pouchitis; Tryptophan
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Enteritis; Ileitis; Ileal Diseases; Pouchitis; Psychotropic Drugs; Antidepressive Agents; Antidepressive Agents, Second-Generation; Tryptophan
• Other Study ID Numbers: 2025-101427-BO-ff; Intramural funding (Other Grant/Funding Number: I. Medizinische Klinik und Poliklinik, UKE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD will not be shared without resonable request. If, after publication, researches ask for IPD for further analysis, anonymized data will shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No