Non-antibiotic Management in Acute Uncomplicated Diverticulitis

NCT07625267 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 2025-17516
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diverticulitis, Colonic; Anti-Bacterial Agents; Outpatients; Watchful Waiting; Acute Disease

Outcome Measures

Primary Outcomes (1)

• Diverticulitis-related hospitalization rate

  Diverticulitis-related hospitalization rate will be summarized as a frequency measure. The number/percentage of participants requiring hospital admission for any cause related to acute diverticulitis or its complications, including disease progression, intractable pain, intolerance to oral intake, abscess formation, perforation, or need for surgical intervention will be summarized by study arm. Hospitalizations unrelated to diverticulitis will not be counted.

  Up to 6 months after enrollment

Secondary Outcomes (4)

• Emergency Department revisit rate

  Up to 6 months after enrollment

• Progression to complicated diverticulitis

  Up to 6 months after enrollment

• Need for surgery

  Up to 6 months after enrollment

• Recurrence of acute diverticulitis

  Up to 6 months after enrollment

Other Outcomes (3)

• Pain control assessed by Visual Analog Scale

  At 1-2 weeks, 4 weeks, 3 months, and 6 months after enrollment

• Treatment-related adverse events

  At 1-2 weeks, 4 weeks, 3 months, and 6 months after enrollment

• Medication adherence

  At 4 weeks after enrollment

Study Arms (2)

No-Antibiotic Group

EXPERIMENTAL

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.

Drug: Symptomatic treatment (ibuprofen and acetaminophen)

Standard Antibiotic Therapy

ACTIVE COMPARATOR

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.

Drug: Symptomatic treatment (ibuprofen and acetaminophen); Drug: Amoxicillin-clavulanate; Drug: Ciprofloxacin plus metronidazole

Interventions

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.

Also known as: Augmentin

Standard Antibiotic Therapy

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.

Also known as: Cipro plus Flagyl

Standard Antibiotic Therapy

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.

Also known as: Pain control regimen

No-Antibiotic Group; Standard Antibiotic Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (4)

• 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.

  PMID: 29700480 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.

  PMID: 32384404 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.

  PMID: 33279517 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.

  PMID: 26453777 BACKGROUND

MeSH Terms

Conditions

Diverticulitis, Colonic; Acute Disease

Interventions

Ibuprofen; Acetaminophen; Amoxicillin-Potassium Clavulanate Combination; Ciprofloxacin; Metronidazole

Condition Hierarchy (Ancestors)

Diverticulitis; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Diverticulosis, Colonic; Colonic Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• James Taylor, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeisson Rivero Moreno, MD

CONTACT

19178075141; yriveromor@montefiore.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)