Gut response to a Mediterranean diet in children with cystic fibrosis
Official title: Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet
Run by Dartmouth-Hitchcock Medical Center · NCT07223255 · Data updated 2026-11-12
This project will try a Mediterranean-style diet in children with cystic fibrosis to see if it lowers gut inflammation, shifts the gut microbiome toward healthier bacteria, and supports better nutrition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 3 Years to 18 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 2 sites (Lebanon, New Hampshire and 1 other locations) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | July 2, 2026 |
| Trial ID | NCT07223255 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 3 years or older with confirmed cystic fibrosis, a BMI Z-score ≥ -1, on a full solids diet (pancreatic insufficient children on PERT and pancreatic sufficient children not on PERT are eligible), whose families agree to follow an exclusive Mediterranean-style diet for six months and can attend regular clinic visits.
✕Probably not a fit
Children who are malnourished, require tube feeding, have poorly controlled CF lung disease, advanced CF liver disease, or comorbid malabsorptive gastrointestinal diseases (e.g., celiac disease, Crohn's) are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study enrolls children aged 3 and older with confirmed cystic fibrosis who have a BMI Z-score of -1 or higher and are on a solids-based diet. Families will follow an exclusive Mediterranean-style diet for six months while participants continue routine CF care and clinic follow-up. Investigators will monitor gastrointestinal inflammation markers, gut microbiome composition, and nutritional status before and after the intervention. The trial responds to changing nutritional needs in the era of highly effective modulators, when obesity and altered metabolism are increasingly observed in pediatric CF.
Why it matters
Potential benefit: If successful, the diet could provide concrete guidance to reduce gut inflammation, promote a healthier gut microbiome, and help maintain appropriate weight and overall health for children with CF.
How similar studies have gone: Mediterranean-style diets have shown anti-inflammatory effects and favorable microbiome shifts in metabolic and inflammatory bowel conditions, but this specific intervention is novel and largely untested in pediatric cystic fibrosis.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
Dartmouth Health Children's
Manchester, New Hampshire, United States Recruiting -
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States Not yet recruiting
Study contacts
- Study coordinator: Julie L Sanville, MD
- Email: Julie.L.Sanville@hitchcock.org
- Phone: 603-653-9666
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.