Analysis of the Role of the Microbiota in Diverticular Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital of Navarra
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older.
Signing of the informed consent form.
Assignment to one of the study groups mentioned above.
Disqualifiers
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.
Trial population
Patients attended in outpatient clinics, the gastrointestinal endoscopy unit, and the emergency department at the University Hospital of Navarra
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
285 Participants
are grouped into 4 trial groupsGroup A: healthy patient
Group B: Patients with asymptomatic diverticulosis
Group C: Patients with a first episode of acute diverticulitis
Group D: Patients with recurrent acute diverticulitis
Trial outcomes
Primary outcomes
1
To investigate the microbiota influences the development of diverticulosis
To investigate whether the microbiota influences the development of diverticulosis and a first episode of acute diverticulitis.
Time frame
From the diagnosis until two yearsSecondary outcomes
1
To investigate how the microbiota affects the therapeutic response in patients presenting with a first episode of acute diverticulitis.
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 weeks2
To investigate how the microbiota is affected in patients treated with anti-inflammatory drugs versus antibiotic therapy.
To investigate how the microbiota is affected in patients treated with anti-inflammatory drugs versus antibiotic therapy.
Time frame
From the diagnosis until 8 weeks3
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.
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 yearsSponsors and contacts
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Source ClinicalTrials.gov
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