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NCT06861140 | NOT YET RECRUITING | Pouchitis


Exploring the Influence of Trptophan on the Treatment of Pouchitis
Sponsor:

University Hospital 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.

Condition or disease

Instigatis

Intervention/treatment

Tryptophan 25mg/kg bodyweight

Placebo

Phase

NA

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
Estimated Enrollment : 20 participants
Masking : TRIPLE
Masking Description : care providers, Investigators and Outcome Assessors are blinded.
Primary Purpose : TREATMENT
Official Title : Investigation of the influence of a diet -rich diet on the therapeutic potential of probiotics after antibiotic therapy for chronic pouchitis (Try Pro Pouch). A prospective randomized controlled double -blind intervention study
Actual Study Start Date : 2025-04-01
Estimated Primary Completion Date : 2027-04-30
Estimated Study Completion Date : 2027-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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)

Exploring the Influence of Trptophan on the Treatment of Pouchitis

Location Details

NCT06861140


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