Study of Celecoxib Alone Versus Celecoxib with Metformin to Prevent Polyps in Familial Adenomatous Polyposis Patients Aged 20 to 55

What this Trial Is About

Familial adenomatous polyposis FAP is a condition that causes the development of many polyps in the colon and sometimes the duodenum, which can lead to cancer. Researchers are studying chemopreventive approaches to delay polyp and cancer growth in FAP patients. This study focuses on comparing the effects of celecoxib alone versus a combination of celecoxib and metformin on polyps in these patients, aiming to find safer prevention methods with fewer side effects than current treatments. Participants will be randomly assigned to one of two groups one group will receive celecoxib alone at 400 mg twice daily, and the other group will receive celecoxib 400 mg twice daily combined with metformin 1 gram twice daily. Both treatments will be taken orally for six months. The study includes baseline and six-month endoscopic examinations of the colon, rectum, and upper gastrointestinal tract to assess the number, size, and overall extent of polyps, using photographs from marked areas. During the study, participants will undergo colonoscopy or sigmoidoscopy and upper gastrointestinal endoscopy at the start and end of treatment. Researchers will measure changes in polyp number and size as the primary outcome. They will also perform qualitative assessments of the overall polyposis extent. The study monitors participants for six months of treatment and includes careful evaluation of their response to the medications. The total duration of participation is about six months, with assessments focused on polyp changes and safety.

Chemopreventive Effect of Combination of Celecoxib and Metformin in Patients With Familial Adenomatous Polyposis