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Mediterranean Diet for Pediatric Cystic Fibrosis Gastrointestinal Health

This study is looking at how a Mediterranean diet affects children with cystic fibrosis (CF). Doctors want to understand if this diet can help with gut health in children aged 3 to 18 who have CF. Currently, there isn't much guidance on specific diets for CF patients, and doctors are seeing more questions about healthy eating as CF patients live longer. This study aims to provide better advice for families. You might be able to join if you have CF, are between 3 and 18 years old, and meet certain nutritional and diagnostic criteria. The main way they will measure success is by looking at changes in your gut bacteria (metagenomic sequencing) after 6 months on the diet.

Study design
This is an interventional study, meaning participants will follow a specific plan. It aims to enroll 20 children with cystic fibrosis.
What's involved
If you join, you will follow a Mediterranean diet for a 6-month period. Your gut bacteria will be measured at the end of this period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months, which is when the primary endpoint (metagenomic sequencing) is measured.

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NCT07223255

Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet

Recruiting
NAAges 3–18InterventionalSupportive care
Dartmouth-Hitchcock Medical Center
~20 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Mediterranean diet

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Metagenomic sequencing
Measured over 6 months

Conditions

Cystic Fibrosis (CF)
Cystic Fibrosis Gastrointestinal Disease

Explore related trials

Cystic Fibrosis

Where it's being run

2 sites across 1 states
New Hampshire2

Who to contact

Julie L Sanville, MD
[email protected]
603-653-9666
Email the study team

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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

What this trial measures

  • Metagenomic sequencing6 months

    Subjects will adhere to 6 months of exclusive Mediterranean Diet and have post diet intervention analysis of 16s and metagenomic sequencing, cytokine and metabolomic analysis for microbiome assessment.