Investigation of Medical Management to Prevent Episodes of Diverticulitis Trial (NCT05681559) | Clinical Trial Compass
CompletedNot Applicable
Investigation of Medical Management to Prevent Episodes of Diverticulitis Trial
United States71 participantsStarted 2023-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Willingness to enroll
Timeframe: through study completion, over a period of 2 years
2
Adherence to Med-Style Food Pattern
Timeframe: through study completion, over a period of 12 months
3
Participant retention
Timeframe: through study completion, over a period of 12 months
4
Engagement with nutrition services
Timeframe: Quarterly through study completion, over a period of 12 months
5
Interaction with online program
Timeframe: Bi-weekly through study completion, over a period of 12 months