Mediterranean Diet and Gut Health in Children with Cystic Fibrosis
Tests a Mediterranean diet for gut health in children with cystic fibrosis.
Key facts
- Who runs it
- Dartmouth-Hitchcock Medical Center
- Where
- Lebanon and Manchester, United StatesSee the 2 sites
- Trial code
- Registry title
- Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet
- Status
- Recruiting
- People taking part
- 20 people, planned
- Started
- 1 Sept 2026
- Expected to end
- Jun 2027
- Type of study
- Interventional
- Treatments tested
- Mediterranean diet
- Record updated
- 2 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children with cystic fibrosis who eat a full diet of solid foods. Families must be willing to follow a Mediterranean style diet for 6 months.
- Age
- 3 to 18 years
- Sex
- Boys and girls
- Disease stage
- Confirmed cystic fibrosis: 2 CF-causing mutations on genetic testing, or sweat chloride greater than 60 mEq/L. Children with or without pancreatic insufficiency can join.
- Earlier treatment
- Children with pancreatic insufficiency must be on PERT. Children with pancreatic sufficiency must not be on PERT.
- Biomarker or test result
- BMI Z-score of at least -1 or above. 2 CF-causing mutations on genetic testing, or sweat chloride greater than 60 mEq/L.
Main reasons for not taking part
- Malnutrition
- Needs feeding through any type of feeding tube
- Poorly controlled CF lung disease
- Advanced CF liver disease
- Another gut disease such as celiac disease or Crohn's disease, or significant food allergies
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Children with malnutrition
- Children who require nutritional supplementation via any type of feeding tube
- Family is unwilling to adhere to prescribed dietary intervention
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 3 and 18 years old?
Where in United States
- Dartmouth Hitchcock Medical CenterLebanon, United StatesContact: Julie L Sanville, DONot yet recruiting
- Dartmouth Health Children'sManchester, United StatesContact: Julie Sanville L PI, DOTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- med dietTreatment being tested
Mediterranean diet
Treatment: Mediterranean diet
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet
- Plain-language title
- Mediterranean Diet and Gut Health in Children with Cystic FibrosisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07223255, who can take part
- Record updated
- 2 July 2026