Diverticular Disease Clinical Trials

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Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to determine whether antibiotics improve recovery from acute uncomplicated diverticulitis (AUD) in racially and ethnically diverse United States clinical practice. The main questions it seeks to answer are: * What is the feasibility for completing a subsequent definitive efficacy trial of antibiotics vs. placebo to treat AUD? * What are the needs for successful recruitment of racial and ethnic subgroups? * What are the effects of a placebo compared to antibiotics for AUD on a range of key patient-centric efficacy and safety endpoints? * How do such effects differ by race and ethnicity? Researchers will compare a placebo to antibiotics to see if AUD can be treated without using antibiotics. Participants will: * Take two antibiotics or a matching placebo every day for 10 days * Receive analgesia, gastric protection, diet modifications, and a follow-up * Submit daily photos of pills to the study team to verify adherence

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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.

Locations
United States
Tennessee
Vanderbilt University Medical Center Emergency Department
RECRUITING
Nashville
Time Frame
Start Date: 2026-07-07
Estimated Completion Date: 2028-10-01
Participants
Target number of participants: 100
Treatments
Active_comparator: Antibiotic
The primary antibiotic choice will be amoxicillin-clavulanate (1 tablet \[875 mg amoxicillin; 125 mg clavulanic acid\] every 8 hours). If the subject has an allergy or contraindication to the primary antibiotic, we will administer cefuroxime \[500 mg\] every 12 hours plus metronidazole \[500 mg\] every 12 hours.
Experimental: Placebo
A placebo matching the antibiotic arm's treatment regimen will be administered for 10 days
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov

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