Status:
NOT_YET_RECRUITING
Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Cystic Fibrosis (CF)
Cystic Fibrosis Gastrointestinal Disease
Eligibility:
All Genders
3-18 years
Phase:
NA
Brief 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 we, as C...
Detailed Description
The dietary needs of children with Cystic Fibrosis continue to change. With the advent of highly effective modulator therapy, these needs are profoundly shifting away from the standard advice of high ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07223255
Start Date
January 1 2026
End Date
June 1 2027
Last Update
October 31 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
2
Dartmouth Health Children's
Manchester, New Hampshire, United States, 03104