Vedolizumab for the Treatment of Collagenous Gastritis
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
11 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Michael Dougan, MD, PhD; Keri Sullivan
Data sourced from clinicaltrials.gov
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