Non-antibiotic Management in Acute Uncomplicated Diverticulitis

Conditions

• Acute Uncomplicated Diverticulitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Symptomatic treatment (ibuprofen and acetaminophen) — DRUG
  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.
• Amoxicillin-clavulanate — DRUG
  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.
• Ciprofloxacin plus metronidazole — DRUG
  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.

Study Details

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 Dates

Start date

Jul 1, 2026

Status verified

May 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

556 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: No-Antibiotic Group
  Participants randomized to this arm will be discharged from the Emergency Department with symptomatic treatment only, without antibiotics. The regimen consists of oral ibuprofen 400 mg every 8 hours and/or oral acetaminophen 1 g every 8 hours for symptom control, a liquid diet advancing as tolerated, and standardized return precautions. Participants will receive a patient handout with medication instructions, follow-up schedule, and a dedicated contact number for questions or adverse events.
• Active Comparator: Standard Antibiotic Therapy
  Participants randomized to this arm will be discharged from the Emergency Department with standard outpatient antibiotic therapy in addition to symptomatic treatment. The regimen consists of oral amoxicillin/clavulanate 875/125 mg every 12 hours for 7 days, plus oral ibuprofen 400 mg every 8 hours and/or oral acetaminophen 1 g every 8 hours for symptom control, a liquid diet advancing as tolerated, and standardized return precautions. Participants with a documented or self-reported penicillin or beta-lactam allergy will receive oral ciprofloxacin 500 mg every 12 hours plus oral metronidazole 500 mg every 8 hours for 7 days instead of amoxicillin/ clavulanate. Participants will receive a patient handout with medication instructions, follow-up schedule, and a dedicated contact number for questions or adverse events.

Primary Outcome Measure

Diverticulitis-related hospitalization rate [ Time Frame: Up to 6 months after enrollment ]

Central Contacts

• Yeisson Rivero Moreno, MD
  19178075141
  [email protected]

Locations (1)

Find similar trials in The Bronx, NY

Related Studies

• APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
  PHASE2 · Not Yet Recruiting · Vanderbilt University Medical Center · Nashville, Tennessee