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 range

14 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in symtpoms

Timeframe: 12 Weeks

Trial details

NCT IDNCT06317220

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-17

View on ClinicalTrials.gov More Collagenous Gastritis trials