Clinical Trial

Vitamin C With Steroids for Gastrointestinal GVHD

Not Yet Recruiting Early Phase 1
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Summary
After a transplant from another donor, one risk is graft versus host disease (GVHD) that happens because of differences between the donated cells (graft) and the patient's body cells (host). The new cells from the donor might see the body's cells as different and attack them. GVHD can be very serious and cause death. The standard first treatment for GVHD is corticosteroids but not all patients respond and in cases where they don't, they need to go onto other treatments that may or may not be effective. In addition, when GHVD involves the gut it can damage the cells of the gastrointestinal track causing long term problems such as abdominal pain and bowel disturbance. In laboratory studies giving a vitamin C has been able to protect the gastrointestinal cells and help them recover. In this trial the investigators would like to see if vitamin C can do the same thing when given with steroids in patients with GVHD. The standard first treatment for acute GVHD is corticosteroids but not all patients respond and in cases where they don't, they need to go onto other treatments that may or may not be effective. In addition, when GHVD involves the gut it can damage the cells of the gastrointestinal track causing long term problems such as abdominal pain and bowel disturbance. In the laboratory vitamin C has been able to protect gut stem cells and help them recover and the investigators would like to learn if this happens in people too. Vitamin C is a readily available supplement. Vitamin C has NOT been approved by the FDA for the treatment of acute GVHD.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-09-26; most recent amendment 2026-03-03.
Trial Details
NCT Number NCT07197749
Lead Sponsor Baylor College of Medicine
Collaborators: The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions Graft-versus-host-disease (GVHD), Gastrointestinal
Enrollment 35 participants
Start Date 2026-06
Primary Completion 2028-10 (estimated)
Study Completion 2029-10 (estimated)
Updated on ClinicalTrials.gov 2026-03-04