Exploring the Influence of Trptophan on the Treatment of Pouchitis
ConditionPouchitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitätsklinikum Hamburg-Eppendorf
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pouchitis (PDAI >= 7)
indication for the application of antibiotics and probiotics
Age >=18 years
Informed consent
Disqualifiers
major surgery planned druing the intervention
high risk for malnutrition (NRS 2002 >=3/ BMI <18,5 kg/m²)
Trial design
Design model
Parallel
Treatments tested in this trial
Tryptophan 25mg/kg bodyweight
Dietary supplementTryptophan is supplemented during the treatment of chronic pouchitis with pro- and antibiotics
Placebo
Other interventionstandard treatment of chronic pouchitis using pro- and antibiotics.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
from enrollent to end of treatment at 12 weeksSecondary outcomes
1
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.
Time frame
from enrollent to end of treatment at 12 weeks2
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.
Time frame
from enrollent to end of treatment at 12 weeks3
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.
Time frame
from enrollent to end of treatment at 12 weeks4
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.
Time frame
from enrollent to end of observation at 52 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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