New hope for kids with pouchitis: drug trial targets inflammation

NCT ID NCT06443502

Recruiting now Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Aug 04, 2026 · Updated 2 times

Summary

This study tests whether vedolizumab (Entyvio) can improve symptoms and reduce inflammation in children with chronic pouchitis, a condition where an internal pouch becomes inflamed after bowel surgery. About 30 children will receive up to 12 infusions over 82 weeks. The main goal is to see if symptoms and pouch inflammation improve by week 14.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: vedolizumab (Entyvio)
What this could lead to: If successful, this could provide a new treatment option for children with chronic pouchitis, helping control inflammation and improve quality of life.
What could go wrong: This is a small, single-arm study with no placebo group, so results may be less reliable. Side effects of vedolizumab include infusion reactions and increased infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

pouchitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

POUCHITIS

Contacts and locations

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Study contacts

Contact

Email: •••••@•••••

Locations

AOU dell'Universita degli Studi della Campania Luigi Vanvitelli
RECRUITING

Naples, 80138, Italy
Azienda Ospedaliero Universitaria, Policlinico Gaetano Martino
RECRUITING

Messina, 98124, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I
RECRUITING

Rome, 00161, Italy
Children's Hospital Zagreb
RECRUITING

Zagreb, 10000, Croatia
Fakultni nemocnice v Motole, Pediatricka klinika 2
RECRUITING

Prague, 150 06, Czechia
Hospital Sant Joan de Deu
RECRUITING

Esplugues de Llobregat, Barcelona, 8950, Spain
Hospital Universitari I Politecnic La Fe de Valencia
RECRUITING

Valencia, 46026, Spain
IRCCS Materno Infantile Burlo Garofolo
RECRUITING

Trieste, 34137, Italy
Instytut Pomnik-/Centrum Zdrowia dziecka
RECRUITING

Warsaw, 04-730, Poland
Istituto G Gaslini Ospedale Pediatrico IRCCS
RECRUITING

Genova, 16147, Italy
Schneider Children's Medical Center of Israel
RECRUITING

Petah Tikva, 4920235, Israel
Shaare Zedek Medical Center
RECRUITING

Jerusalem, 9103102, Israel
Sotiria Thoracic Diseases Hospital, Dpt. of Gastroenterology, Building Z
RECRUITING

Athens, Attica, 115 27, Greece
UZ Leuven
RECRUITING

Leuven, Vlaams-Brabant, 3000, Belgium

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