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NCT07625267 · ClinicalTrials.gov registry record · Phase 4
Non-antibiotic Management in Acute Uncomplicated Diverticulitis
A Phase 4 study, sponsored by Montefiore Medical Center.
- Not yet
- Registry status
- Phase 4
- Development phase
- 556
- Enrollment target
NCT07625267 is a Phase 4 study that has not yet begun recruiting, run by Montefiore Medical Center. The registered enrollment target is 556 participants.
The verdict
NCT07625267, a Phase 4 study, has not yet begun recruiting, sponsored by Montefiore Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 556 participants
- Enrollment target
Study 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
Interventions
- DRUG Amoxicillin-clavulanate
- DRUG Symptomatic treatment (ibuprofen and acetaminophen)
- DRUG Ciprofloxacin plus metronidazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 556 participants |
| Start Date | 2026-07-01 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07625267
The ClinicalTrials.gov registry entry for NCT07625267 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 556 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Montefiore Medical Center, which has 345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Amoxicillin-clavulanate is the first listed.
NCT07625267 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07625267 about?
NCT07625267 is a clinical study titled "Non-antibiotic Management in Acute Uncomplicated Diverticulitis". 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 Euro...
What is the current status of trial NCT07625267?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 556 participants. The study started on 2026-07-01. Estimated completion is 2028-06-30.
What interventions are being tested in trial NCT07625267?
The interventions under investigation include: Amoxicillin-clavulanate (DRUG), Symptomatic treatment (ibuprofen and acetaminophen) (DRUG), Ciprofloxacin plus metronidazole (DRUG).
Who is sponsoring clinical trial NCT07625267?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
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