Analysis of the Role of the Microbiota in Diverticular Disease

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07681505

Enrollment

285

Registered

2026-07-02

Start date

2027-06-01

Completion date

2032-01-01

Last updated

2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Diverticulitis, Diverticular Disease of Colon, Gut Microbiota

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
To investigate the microbiota influences the development of diverticulosis	From the diagnosis until two years	To investigate whether the microbiota influences the development of diverticulosis and a first episode of acute diverticulitis.

Secondary

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

Countries

Spain

Outcome results