Antibiotics or placebo for acute uncomplicated diverticulitis in diverse US patients
Official title: Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis
Run by Vanderbilt University Medical Center · NCT07492134 · Data updated 2026-11-12
This study tests whether antibiotics help people with acute uncomplicated diverticulitis, compared with a placebo, in diverse patients treated in US emergency departments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Status | Recruiting |
| Started | July 7, 2026 |
| Main results expected | April 1, 2028 |
| Study ends | October 1, 2028 |
| Registry record updated | September 21, 2026 |
| Trial ID | NCT07492134 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–90 with radiologically confirmed left-sided moderate AUD, access to a smartphone, and no contraindications to the study medications.
✕Probably not a fit
Patients with complicated diverticulitis, other colonic diseases, recent antibiotic use, or conditions that increase infection risk may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2 trial compares antibiotics to placebo for acute uncomplicated diverticulitis (AUD) in adults presenting to the emergency department. Participants are randomized to receive either antibiotics or a matching placebo for 10 days, along with standard supportive care and daily pill-adherence checks via photos. The study also focuses on recruitment and outcomes across racial and ethnic subgroups to see if treatment effects differ by race/ethnicity. Primary aims include feasibility for a larger definitive trial and the safety and efficacy signals of antibiotics versus placebo. The trial is conducted at Vanderbilt University Medical Center with collaboration from NIDDK, enrolling adults aged 18 to 90 with radiologically confirmed moderate AUD and no complicating factors.
Why it matters
Potential benefit: If successful, the trial could support managing AUD without routine antibiotics, potentially reducing antibiotic use and resistance.
How similar studies have gone: Previous studies in similar areas have explored antibiotic vs. placebo strategies, but this trial emphasizes diversity and feasibility for a larger definitive study.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients presenting to the emergency department with left-sided uncomplicated diverticulitis * Radiologic score (moderate diverticulitis per Ambrosetti classification) * Age 18-90 * Access to a smartphone with internet access. Exclusion Criteria: * Complicated diverticulitis (abscess, free air, peritonitis)- severe diverticulitis by Ambrosetti classification * Diverticulitis other than left colon * Contraindication to use of study medication (ie advanced renal failure or allergy to all antibiotics used in the study) * Concurrent cancer diagnosis * Concurrent IBD Diagnosis * Any other disease process with life expectancy \< 6 months * Concurrent chronic pain diagnosis. * Women in pregnancy or breastfeeding * Antibiotic treatment for any reason in the last 3 weeks * Diagnosis of prior episode of acute diverticulitis in the past 3 months * Significant comorbidities: diabetes mellitus with organic involvement (retinopathy, angiopathy, nephropathy), emergency assistance for a cardiogenic event in the last 3 months (acute myocardial infarction, angina, heart failure), decompensation of chronic liver disease in the last 3 months (Child ≥ B) and end-stage renal disease. * Immunodepression: the absence, and immunodepression is the presence, of any of the following: active neoplastic disease, hematologic malignancy, human immunodeficiency virus long-term corticosteroid treatment, immunosuppressant therapy (20mg pred (or equivalent) for \>2 weeks), transplant, splenectomy and genetic immunodeficiency * Previous colectomy * Patients with dementia, memory disorders or other cognitive impairment that would impact their ability to provide informed consent or otherwise participate in the trial
Where it's running
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Vanderbilt University Medical Center Emergency Department
Nashville, Tennessee, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.