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Vedolizumab for the Treatment of Collagenous Gastritis

Vedolizumab for the Treatment of Collagenous Gastritis

Recruiting
14 years and older
All
Phase 2

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Overview

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

Description

Eligible participants will receive vedolizumab through an IV ("infusion") at week 0, then week 2, then week 6. Participants who respond well to the treatment after the first 3 infusions and are interested in continuing will receive vedolizumab every 8 weeks for about 1 year. At each visit, participants will be asked about their collagenous gastritis symptoms and any changes in their health or medications.

Blood samples will be collected from participants at every vedolizumab infusion. Some of these samples will be collected for safety purposes, some will be collected to monitor CG progression, and some will be collected for research purposes.

During the screening period and a few months after beginning treatment, the study doctor will perform an upper endoscopy to help determine whether vedolizumab has improved each participant's CG. An upper endoscopy is a procedure where the doctor inserts a small tube with a camera through the mouth and down the throat to look at the upper gastrointestinal tract (the esophagus, stomach, and part of the small intestine). During the procedure, biopsies will be collected to monitor CG and for research purposes. All participants will be given medication to make them comfortable throughout the duration of the procedure, which lasts approximately 10 to 30 minutes.

Eligibility

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

Study details
    Collagenous Gastritis

NCT06317220

Massachusetts General Hospital

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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