Hospital Obispo Polanco
Teruel, Spain
RecruitingDiverticulitis
Outpatient Treatment Without Antibiotics or with Ciprofloxacin, Cefuroxime, Cefditoren Pivoxil, Amoxicillin/Clavulanic Acid, and Metronidazole in Adults with Acute Uncomplicated Diverticulitis
Verified siteRegistered drug
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is studying acute uncomplicated diverticulitis, a condition in which small pouches in the bowel become inflamed, without signs of a more serious infection. The purpose of the study is to compare outpatient treatment without antibiotics with outpatient treatment using antibiotics.
The treatments being studied are oral tablets of metronidazole, amoxicillin/clavulanic acid, cefditoren pivoxil, ciprofloxacin, and cefuroxime. These are medicines taken by mouth that are commonly used to treat bacterial infections. The study looks at whether people can be treated safely without antibiotics or whether antibiotic treatment works better in this condition.
People in the study receive outpatient care, meaning treatment without staying in the hospital. The course of the study includes starting treatment and then follow-up over time to see how the condition improves or returns. The study also checks for any later episodes of diverticulitis and how quickly normal daily activities are resumed. The trial is being carried out at several centers.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
6 criteria
- Be over 18 years old.
- Have a clinical diagnosis, meaning the doctor’s examination and symptoms show the condition, of uncomplicated acute diverticulitis in the sigmoid colon or descending colon on the left side of the abdomen.
- Have a radiological diagnosis, meaning the condition is confirmed by an imaging test, of acute uncomplicated diverticulitis on a CT scan (a detailed X-ray test that creates pictures of the inside of the body).
- Have a CT scan result that matches modified Hinchey classification 0-Ia, which means the inflammation is mild and there is no complicated infection.
- Have either a first episode of diverticulitis or a previous history of diverticulitis, whether it was complicated or uncomplicated, as long as at least 6 months have passed since the last episode before the current clinic visit.
- Be willing to sign the informed consent form, which means the patient agrees to take part after understanding the study.
Who cannot join the trial?
8 criteria
- Being older than 70 years.
- Having signs that make hospital treatment necessary instead of outpatient treatment, such as repeated vomiting, not being able to keep down food or drink, needing intravenous fluids (fluids given through a vein), needing close medical monitoring, having a temperature above 38°C, getting worse overall, or having a medical concern for sepsis (a serious body-wide reaction to infection).
- Having a serious illness that is not well controlled, called decompensated comorbidity, or being classified as ASA IV (this means a very severe general health condition).
- Having a weakened immune system, including blood-related causes, HIV with low CD4+ levels (a type of immune cell), treatment that suppresses the immune system, long-term corticosteroid use (steroid medicines), chemotherapy, having had an organ transplant, having had the spleen removed, or having certain genetic immune disorders such as severe combined immunodeficiency.
- Having taken antibiotics by mouth or through a vein in the 2 weeks before the symptoms started, for a different reason.
- Being pregnant.
- Having inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
- Not having enough social support to make outpatient treatment possible, meaning there is no practical help at home or in daily life to safely follow the treatment plan.
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Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Verified Verified Hospital Universitario De Getafe
Getafe, SpainVerified University Clinical Hospital Virgen De La Arrixaca
Murcia, Spain
Trial locations
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Investigated drugs
Metronidazole
is an antibiotic taken by mouth. In this trial, it is one of the medicines used to treat the infection and inflammation linked to uncomplicated acute diverticulitis.
Amoxicillin and clavulanic acid
is an antibiotic treatment taken by mouth. It combines two medicines that work together to fight bacteria, and it is used in this trial as one of the antibiotic treatment options for diverticulitis.
Cefditoren pivoxil
is an antibiotic taken by mouth. In this trial, it is used as another treatment option to help fight the bacteria involved in diverticulitis.
Ciprofloxacin
is an antibiotic taken by mouth. In this trial, it is used to treat the infection as part of the antibiotic treatment group for diverticulitis.
Cefuroxime
is an antibiotic taken by mouth. In this trial, it is used as one of the medicines chosen to treat diverticulitis in the antibiotic treatment group.
What is already known about the treatment
Metronidazole
Metronidazole is taken by mouth as a tablet and is used to treat certain infections caused by bacteria and some parasites. It is still an important medicine in medical practice and is well described in medical literature, especially for infections in the gut and other areas where germs do not need oxygen to grow. It works by entering the germ and damaging its genetic material, which stops the germ from multiplying. It belongs to the group of antibiotic and antiparasitic medicines called nitroimidazoles.
Amoxicillin/Clavulanic acid
This medicine is taken by mouth as a film-coated tablet, usually with water, and is commonly used at home for infections. It remains widely used in medicine and is well established in medical literature, especially for infections of the lungs, skin, urinary tract, and abdomen. Amoxicillin kills bacteria by blocking the formation of their cell wall, while clavulanic acid helps protect amoxicillin from being broken down by bacterial defenses. It belongs to the penicillin-type antibiotic group combined with a beta-lactamase inhibitor.
Cefditoren pivoxil
Cefditoren pivoxil is taken by mouth as a film-coated tablet and is used to treat bacterial infections. It is an accepted antibiotic in medical practice and appears in medical literature as a treatment option for selected respiratory and skin infections. After it is absorbed, it is converted into cefditoren, which stops bacteria from building a strong cell wall, leading to their death. It belongs to the cephalosporin antibiotic group.
Ciprofloxacin
Ciprofloxacin is taken by mouth as a coated tablet and is used to treat a range of bacterial infections. It remains an important antibiotic in medicine and is well known in the medical literature, although its use is often limited to cases where it is truly needed because of possible side effects. It works by blocking two bacterial enzymes needed for copying and repairing genetic material, which prevents the bacteria from growing. It belongs to the fluoroquinolone antibiotic group.
Cefuroxime
Cefuroxime is taken by mouth as a film-coated tablet and is used for bacterial infections. It is still used in medical practice and is well described in medical literature, especially for infections of the throat, lungs, skin, and urinary tract. It works by stopping bacteria from making a proper cell wall, which weakens and kills them. It belongs to the cephalosporin antibiotic group.
Investigated diseases
Diverticular disease of the intestine - Diverticular disease of the intestine is a condition in which small pouches form in the wall of the intestine, most often in the large intestine. It may remain mild for long periods or progress to inflammation when one or more pouches become irritated or infected, causing acute diverticulitis. Over time, some people have repeated episodes, and the condition can sometimes become more severe with ongoing inflammation.
Ongoing clinical trials in Diverticulitis
Other trials in this disease – keep exploring while you decide
Recruiting
Diverticulitis
RecruitingRegistered drug
Study on MBK-01 and Drug Combination for Treating Patients with Recurrent Diverticulitis
Registered drug
- Disease:Diverticulitis
- Substances:AmoxicillinFosfomycin+2
Countries:Spain
Spain- Participants:18–64 years · 65+ years
- Substances:Amoxicillin
- Sponsor:Mikrobiomik Healthcare Company S.L.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523121-17-00Protocol codeIMIB-ADI-2025-01Estimated enrolment282 patientsSponsorFundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia
sourced from the EU Clinical Trials Register and site verification
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