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Completed
NCT05681559
Investigation of Medical Management to Prevent Episodes of Diverticulitis Trial
Conditions: Diverticulitis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 71
Sponsor: University of Washington
Location: Harborview Medical Center Seattle Washington
Summary
This is a randomized trial (n=75) of a Mediterranean style Food Pattern and versus standardized guidance on fiber intake for patients with diverticulitis to evaluate the feasibility of this dietary intervention including willingness to randomize and adherence to a Med-style dietary pattern. The investigators will employ state-of-the-art behavioral interventions in the form of electronic feedback to improve health-related behaviors and support dietary customization based on participants' budget, dietary preferences, and restrictions. The investigators will also examine plasma inflammatory biomarkers (interleukin-6, interleukin-10, and interleukin-1β) and fecal calprotectin at baseline, 6, and 12 months.
Eligibility Criteria
Inclusion Criteria:
* Adult ≥18 years;
* Patients presenting (or recently presented) to gastroenterologist or surgeons or accessing study website after recovery from an episode of diverticulitis (within the prior 18 months), either the index episode or recurrent.
* Ability to provide written informed consent in English.
Exclusion Criteria:
* Unable or unwilling to return for specimen collection visits or be contacted for and/or complete research surveys;
* Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
* Last episode of acute diverticulitis currently unresolved (i.e., on antibiotics for diverticulitis; drain in place);
* Intolerance/allergy to the main components of the Med-style food pattern;
* Surgery for diverticulitis within past 6 months without an episode of diverticulitis post-surgery;
* Planned elective surgery in next 6 months
Source: ClinicalTrials.gov (NCT05681559). StuddyBuddy aggregates publicly available trial information.