Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet

NCT07223255 | Recruiting

• 2 other identifiers: 02003100P30DK117469
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystic Fibrosis (CF); Cystic Fibrosis Gastrointestinal Disease

Keywords

cfmed; meddiet; meddiet cf; mediterannean diet; cystic fibrosis; CF with Mediterranean diet

Outcome Measures

Primary Outcomes (1)

• Metagenomic sequencing

  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.

  6 months

Secondary Outcomes (1)

• Fecal calprotectin

  6 months

Study Arms (1)

med diet

EXPERIMENTAL

Mediterranean diet

Other: Mediterranean diet

Interventions

Mediterranean diet OTHER

Patients enrolled in this study will follow a Mediterranean diet for a 6 month period.

med diet

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

NOT YET RECRUITING

Dartmouth Health Children's

Manchester, New Hampshire, 03104, United States

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Julie L Sanville, MD

CONTACT

603-653-9666; Julie.L.Sanville@hitchcock.org

Sarah P Winslow, RN

CONTACT

603-629-1849; Sarah.P.Winslow@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: October 31, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)