Investigation of Medical Management to Prevent Episodes of Diverticulitis Trial
Completed · Not applicable
Conditions studied: Diverticulitis
In brief
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.
Key facts
- Study ID
- NCT05681559
- Run by
- University of Washington
- People needed
- 71
- Starts
- 2023-01-01
- Expected to finish
- 2026-02-17
- Last updated by the study team
- 2026-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Harborview Medical Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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