Actively Recruiting
Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet
Led by Dartmouth-Hitchcock Medical Center · Updated on 2026-05-05
20
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
Sponsors
D
Dartmouth-Hitchcock Medical Center
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female pediatric patients with cystic fibrosis age 3 and older
- Nutritional status defined as a BMI Z-score of at least -1 or above
- Confirmed diagnosis of CF by 2 CF-causing mutations on genetic testing or sweat chloride greater than 60 mEq/L
- Children with pancreatic insufficient CF on pancreatic enzyme replacement therapy (PERT)
- Children with pancreatic sufficient CF not on PERT
- Child must be on a full, solids-based diet
- Family willing to have child adhere to an exclusive Mediterranean style diet for 6 months
- Child must be able to follow up at regular CF clinic visits and attend additional study visits if necessary
You will not qualify if you...
- Children with malnutrition
- Children who require nutritional supplementation via any feeding tube
- Children with poorly controlled CF lung disease
- Children with advanced CF liver disease
- Children with comorbid gastrointestinal diseases such as celiac disease, Crohn's disease, or other malabsorptive conditions
- Children with significant food allergies or gastrointestinal allergies
- Family unwilling to adhere to the prescribed dietary intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Not Yet Recruiting
2
Dartmouth Health Children's
Manchester, New Hampshire, United States, 03104
Actively Recruiting
Research Team
J
Julie L Sanville, MD
CONTACT
S
Sarah P Winslow, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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