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

Universitätsklinikum Hamburg-Eppendorf

Status: Not yet enrolling

Conditions: Pouchitis

Treatments: Dietary Supplement: Tryptophan 25mg/kg bodyweight; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06861140

Intramural funding (Other Grant/Funding Number)

2025-101427-BO-ff

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Intervention

Experimental group

Description:

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

Treatment:

Dietary Supplement: Tryptophan 25mg/kg bodyweight