Non-antibiotic Management in Acute Uncomplicated Diverticulitis

Starting soon · Phase 4

Conditions studied: Acute Uncomplicated Diverticulitis

In brief

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

Key facts

Study ID

NCT07625267

Run by

Montefiore Medical Center

People needed

556

Starts

2026-07-01

Expected to finish

2028-06-30

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Left-sided diverticulitis, primary or recurrent
• Signs of diverticulitis on CT-confirmed Hinchey (0 or 1a based on CT final report)
• White Blood Cell (WBC) count <15,000mm\^3
• Controlled symptoms in the ED (i.e., Pain score <5 on VAS scale, tolerating PO intake, no fever)

You may not qualify if…

• Signs of complicated diverticulitis on CT with abscess, fistula, free air, Micro perforation, or signs of other diagnosis on CT Abdomen and pelvis
• Inflammatory bowel disease
• American Society for Anesthesiologists (ASA) physical status classification of >=3
• Immunocompromised patient; (i.e., haematological malignancies, AIDS patients with low CD4+ counts, transplantation, chemotherapy, splenectomy, long-term corticosteroid use and genetic disorders such as severe combined immunodeficiency
• Pregnancy
• Ongoing antibiotic therapy or in the previous 2 weeks
• High fever, affected general condition, peritonitis or sepsis
• Subjects who do not have the capacity to consent

Where it is running

• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.