Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet (NCT07223255) | Clinical Trial Compass
RecruitingNot Applicable
Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet
United States20 participantsStarted 2026-09-01
Plain-language summary
There is no study to date that has evaluated the impact or effect of a Mediterranean diet in children with CF. The goal of this study would be to help provide better guidance around questions the investigators, as CF care providers continue to receive from patients and families about how to best promote overall health in pediatric cystic fibrosis from a dietary perspective. Currently, the updated nutritional recommendations are variable and broad. Parents continue to search for more concrete guidance about how best to promote long-term health given the ever-increasing life expectancy of cystic fibrosis patients in this new area of advanced therapeutics. Given the changing landscape of the CF care in general, children are less likely to struggle with early life malnutrition, and it is becoming increasingly clear that high fat, high calorie diets are not beneficial nor are necessary for all children with CF.
Who can participate
Age range
3 Years – 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:
* Male and female pediatric patient with cystic fibrosis age 3 and older
* Nutritional status defined as a BMI Z-score of at least -1 or above
* Confirm diagnosis of CF defined by 2 CF causing mutations on genetic testing or sweat chloride greater than 60 mEq/L
* Children with pancreatic insufficient CF and on PERT
* Children with pancreatic sufficient CF not on PERT
* Child must be on a full, solids based diet
* Family willing to child adhere to an exclusive Mediterranean style diet for a period of 6 months
* Child must be able to follow-up at regular CF clinic visits and attend any additional study visits if necessary
Exclusion Criteria:
* Children with malnutrition
* Children who require nutritional supplementation via any type of feeding tube
* Children with poorly controlled CF lung disease
* Children with advanced CF liver disease
* Children with a comorbid gastrointestinal disease such as celiac disease, Crohn's disease or other malabsorptive process to be reviewed by PI
* Children with significant food allergies or other gastrointestinal allergy
* Family is unwilling to adhere to prescribed dietary intervention
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.