NCT07223255 Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet
| NCT ID | NCT07223255 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dartmouth-Hitchcock Medical Center |
| Condition | Cystic Fibrosis (CF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-02-01 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07223255 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 18 Years, studying Cystic Fibrosis (CF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07223255 currently recruiting?
Yes, NCT07223255 is actively recruiting participants. Contact the research team at Julie.L.Sanville@hitchcock.org for enrollment information.
Where is the NCT07223255 trial being conducted?
This trial is being conducted at Lebanon, United States, Manchester, United States.
Who is sponsoring the NCT07223255 clinical trial?
NCT07223255 is sponsored by Dartmouth-Hitchcock Medical Center. The trial plans to enroll 20 participants.