Home › Cystic Fibrosis › NCT07223255

Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet

Who can join

Ages 3 to 18 · All sexes

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

About the study

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.

What is being tested

• Mediterranean diet (other)

Sponsor: Dartmouth-Hitchcock Medical Center · Participants: 20 · Started: Sep 1, 2026

Contact the study team

• Julie L Sanville, MD · Phone: 603-653-9666
• Sarah P Winslow, RN · Phone: 603-629-1849

Official record on ClinicalTrials.gov — NCT07223255

Locations in the U.S.

Conditions

• Cystic Fibrosis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.