Analysis of the Role of the Microbiota in Diverticular Disease

A single-center, prospective observational cohort study conducted at the University Hospital of Navarra. The primary objective is to expand knowledge of diverticular disease and its pathological variants, as well as the influence of the microbiota in our environment, both clinically and molecularly; to describe the clinical and pathological characteristics of patients with diverticulosis and acute diverticulitis; to analyze any differences in the microbiota; and to identify the risk factors and groups associated with diverticular disease in order to establish the best strategies for prevention and treatment.

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Key information

Conditions

Diverticular Disease of Colon Acute Diverticulitis Colonic Diseases Digestive System Diseases Diverticulosis, Colonic Gastrointestinal Diseases Gut Microbiota Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario de Navarra

Pamplona, Navarre, 310013, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 or older.
Signing of the informed consent form.
Assignment to one of the study groups mentioned above.

Exclusion criteria

An episode of acute diverticulitis located in the right colon or transverse colon.
Antibiotic treatment within the six weeks prior to the episode (except for antibiotics started in the emergency department or within 24 hours prior to sample collection).
Mechanical bowel preparation within the three weeks prior to sample collection.
Diagnosis of colorectal cancer.
Diagnosis of inflammatory bowel disease.
Failure to sign the informed consent form.

Treatment and study plan

Primary outcomes

To investigate the microbiota influences the development of diverticulosis

Time frame: From the diagnosis until two years

To investigate whether the microbiota influences the development of diverticulosis and a first episode of acute diverticulitis.

Secondary outcomes

To investigate how the microbiota affects the therapeutic response in patients presenting with a first episode of acute diverticulitis.

Time frame: From the diagnosis until 8 weeks

To investigate how the microbiota affects the therapeutic response in patients presenting with a first episode of acute diverticulitis.
To investigate how the microbiota is affected in patients treated with anti-inflammatory drugs versus antibiotic therapy.

Time frame: From the diagnosis until 8 weeks

To investigate how the microbiota is affected in patients treated with anti-inflammatory drugs versus antibiotic therapy.
To analyze the microbiota of patients who experience a recurrence of acute diverticulitis following a first episode compared to those who do not experience a recurrence within the first two years after the episode of acute diverticulitis.

Time frame: From the diagnosis until 2 years

To analyze the microbiota of patients who experience a recurrence of acute diverticulitis following a first episode compared to those who do not experience a recurrence within the first two years after the episode of acute diverticulitis.

Sponsors and collaborators

Lead sponsor

Hospital of Navarra

Other

Registry information

Official study title

Analysis of the Role of the Microbiota in Diverticular Disease.

Important dates

Study start: 2027
Primary completion: 2031
Study completion: 2032
First posted: Jul 2, 2026
Registry last updated: Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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