Active — Not RecruitingPhase 2

Vedolizumab for the Treatment of Collagenous Gastritis

United States11 participantsStarted 2024-12-03

Plain-language summary

The goal of this clinical trial is to learn about how vedolizumab may affect patients with collagenous gastritis (CG). The main questions it aims to answer are: * Whether vedolizumab can reduce CG symptoms * Whether vedolizumab is safe to take for patients with CG Participants in this study will: * Receive vedolizumab through an IV ("infusion") * Complete a survey at each infusion visit * Have blood collected at each infusion visit * Undergo an endoscopy with biopsy at 2 timepoints

Who can participate

Age range14 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 14 or older * Weight of at least 40kg * Has a biopsy-confirmed diagnosis of collagenous gastritis * Agrees to all required study procedures * Presence of one or more collagenous gastritis symptom at a severity of Grade 1 or higher at the time of enrollment: abdominal pain, nausea, diarrhea, bloating, vomiting, flatulence, constipation, fatigue, headache, rash Exclusion Criteria: * Unable to independently provide informed consent or assent * Allergic to vedolizumab or any of its components

What they're measuring

Change in symtpoms

Timeframe: 12 Weeks

Trial details

NCT IDNCT06317220

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Collagenous Gastritis trials