Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet

Recruiting now · Not applicable

Conditions studied: Cystic Fibrosis (CF), Cystic Fibrosis Gastrointestinal Disease

In brief

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.

Key facts

Study ID

NCT07223255

Run by

Dartmouth-Hitchcock Medical Center

People needed

20

Starts

2026-09-01

Expected to finish

2027-06-01

Last updated by the study team

2026-07-02

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dartmouth Health Children's — Manchester, New Hampshire, United States (enrolling)
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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