Non-antibiotic Management in Acute Uncomplicated Diverticulitis
Summary
Diverticulitis is a common condition that causes swelling and pain in part of the colon (the large intestine). Doctors classify it as "mild" when there are no serious complications. For many years, doctors in the United States have treated mild diverticulitis with antibiotics. New studies from Europe suggest that many people with mild diverticulitis may not need antibiotics and can get better with just pain medicines. But this approach has not been tested in the United States, where antibiotics are still the standard treatment. The goal of this clinical trial is to find out if people with mild diverticulitis can be safely treated at home without antibiotics. The main questions it aims to answer are: * Are people treated without antibiotics admitted to the hospital more often than people treated with antibiotics? * Do people treated without antibiotics have more emergency room visits, worsening of their disease, or need for surgery? Researchers will compare two groups of people who come to the emergency department with mild diverticulitis to see if treatment without antibiotics is as safe as treatment with antibiotics. Participants will: * Be sent home with pain medicines (ibuprofen and acetaminophen) only, or with pain medicines plus an antibiotic taken by mouth for 7 days * Follow a liquid diet and slowly return to normal food as they feel better * Come back to clinic for a check-up at 1 to 2 weeks * Answer phone calls about their health at 4 weeks, 3 months, and 6 months
Timeline
- Start
- 2026-07-01
- Primary completion
- 2028-06-30
- Completion
- 2028-06-30
Publications
- Background van Dijk ST, Daniels L, Unlu C, de Korte N, van Dieren S, Stockmann HB, Vrouenraets BC, Consten EC, van der Hoeven JA, Eijsbouts QA, Faneyte IF, Bemelman WA, Dijkgraaf MG, Boermeester MA; Dutch Diverticular Disease (3D) Collaborative Study Group. Long-Term Effects of Omitting Antibiotics in Uncomplicated Acute Diverticulitis. Am J Gastroenterol. 2018 Jul;113(7):1045-1052. doi: 10.1038/s41395-018-0030-y. Epub 2018 May 11.
- Background Hall J, Hardiman K, Lee S, Lightner A, Stocchi L, Paquette IM, Steele SR, Feingold DL; Prepared on behalf of the Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Treatment of Left-Sided Colonic Diverticulitis. Dis Colon Rectum. 2020 Jun;63(6):728-747. doi: 10.1097/DCR.0000000000001679. No abstract available.
- Background Peery AF, Shaukat A, Strate LL. AGA Clinical Practice Update on Medical Management of Colonic Diverticulitis: Expert Review. Gastroenterology. 2021 Feb;160(3):906-911.e1. doi: 10.1053/j.gastro.2020.09.059. Epub 2020 Dec 3.
- Background Stollman N, Smalley W, Hirano I; AGA Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on the Management of Acute Diverticulitis. Gastroenterology. 2015 Dec;149(7):1944-9. doi: 10.1053/j.gastro.2015.10.003. Epub 2015 Oct 8. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amoxicillin | Other / unclassified | — | Oral |
| Comparator | Ciprofloxacin | Small molecule | 500 mg | Oral |
| Comparator | Metronidazole | Small molecule | 500 mg | Oral |
| Background | Acetaminophen | Small molecule | 1 g | Oral |
| Background | Ibuprofen | Small molecule | 400 mg | Oral |