NCT07223255Recruiting
Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 29 Oct 2025
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Diseases
- Cystic fibrosis
- NCT number
- NCT07223255
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Sept 2026 to the primary completion date, 30 Jun 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Children with malnutrition
- Children who require nutritional supplementation via any type of feeding tube
- Family is unwilling to adhere to prescribed dietary intervention
Who the study is looking for
- 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
Age in the registry: 3 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Not yet recruiting |
| Dartmouth Health Children's Coordinator of this site? Confirm its status | Manchester | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.