PouchitisTryProPouchNCT06861140
Exploring the Influence of Trptophan on the Treatment of Pouchitis
A study testing Tryptophan 25mg/kg bodyweight in people with Pouchitis, run by Universitätsklinikum Hamburg-Eppendorf.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pouchitis
- What is being tested?
- Tryptophan 25mg/kg bodyweight
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 30 Apr 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pouchitis (PDAI >= 7)
- indication for the application of antibiotics and probiotics
- Age >=18 years
- Informed consent
Who cannot join
- major surgery planned druing the intervention
- high risk for malnutrition (NRS 2002 >=3/ BMI <18,5 kg/m^2)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read the 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.
- Conditions
- Pouchitis
- Being tested
- Tryptophan 25mg/kg bodyweight, Placebo
- Keywords
- Pouchitis, Antibiotics, Probiotics, Tryptophan, Metabolites
- Medical subject headings
- Pouchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tryptophan 25mg/kg bodyweightDietary supplement
Tryptophan is supplemented during the treatment of chronic pouchitis with pro- and antibiotics
PlaceboOther
standard treatment of chronic pouchitis using pro- and antibiotics.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | regular treatment of pouchitis with consecutive application of antibiotics and probiotics, followed by placebo. Receives: Other: Placebo |
| Intervention | Experimental | regular treatment of pouchitis with consecutive application of antibiotics and probiotics, additional supplementation of tryptophan (25mg/kg bodyweight) Receives: Dietary Supplement: Tryptophan 25mg/kg bodyweight |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrollent to end of treatment at 12 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from enrollent to end of observation at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PouchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional, double-blind, placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel Huber, Prof. Dr. med., Principal investigator, Universitätsklinkum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861140
- Sponsor's protocol ID
- 2025-101427-BO-ff
- Other IDs
- Intramural funding, 2025
- Acronym
- TryProPouch
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be shared without resonable request. If, after publication, researches ask for IPD for further analysis, anonymized data will shared.