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

Conditions

• Acute Uncomplicated Diverticulitis

Interventions

DRUG

Symptomatic treatment (ibuprofen and acetaminophen)

Oral ibuprofen 400 mg every 8 hours and/or oral acetaminophen 1 g every 8 hours, taken as needed for pain control for up to 7 days, combined with a liquid diet advancing as tolerated and standardized return precautions. This symptomatic regimen is administered to participants in both study arms.

DRUG

Amoxicillin-clavulanate

Oral amoxicillin/clavulanate 875/125 mg every 12 hours for 7 days, administered to participants in the antibiotic arm who do not have a documented or self-reported penicillin or beta-lactam allergy. Administered in addition to the symptomatic treatment regimen.

DRUG

Ciprofloxacin plus metronidazole

Oral ciprofloxacin 500 mg every 12 hours plus oral metronidazole 500 mg every 8 hours for 7 days, administered to participants in the antibiotic arm who have a documented or self-reported penicillin or beta-lactam allergy. Administered in addition to the symptomatic treatment regimen as an alternative to amoxicillin/clavulanate.

Sponsors & Collaborators

• Montefiore Medical Center

  lead OTHER

Principal Investigators

• James Taylor, MD · Montefiore Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2028-06-30

Completion

2028-06-30

FDA Drug

Yes