Actively Recruiting
Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet
Led by Dartmouth-Hitchcock Medical Center · Updated on 2026-05-05
20
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Dartmouth-Hitchcock Medical Center
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of a Mediterranean diet on children with cystic fibrosis (CF), particularly focusing on gastrointestinal health. The study addresses the changing nutritional needs of pediatric CF patients in the context of advanced therapies, moving away from traditional high-fat, high-calorie diets. Researchers seek to provide clearer dietary guidance for long-term health, given the increased life expectancy and evolving care landscape for children with CF. Participants will follow a Mediterranean diet exclusively for six months. The study will collect fecal samples before and after the diet to analyze changes in the gut microbiome, inflammation markers, and metabolic profiles. Researchers will also assess symptoms using a gastrointestinal symptom tracker and monitor nutritional status through measurements like weight, height, BMI Z score, and mid-upper arm circumference. Throughout the study, children will attend regular cystic fibrosis clinic visits and any additional study appointments. Researchers will measure primary outcomes using metagenomic sequencing after six months on the diet, alongside secondary outcomes such as fecal calprotectin levels and gastrointestinal symptom scores. The study aims to understand the diet's impact on gut health, inflammation, and nutritional status over the six-month period.
CONDITIONS
Brief Title
Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female pediatric patients with cystic fibrosis aged 3 years and older
- Nutritional status with a BMI Z-score of at least -1 or above
- Confirmed diagnosis of cystic fibrosis by two CF-causing genetic mutations or sweat chloride greater than 60 mEq/L
- Children with pancreatic insufficient CF on pancreatic enzyme replacement therapy (PERT)
- Children with pancreatic sufficient CF not on PERT
- Child must be on a full, solids-based diet
- Family willing to have child adhere to an exclusive Mediterranean diet for 6 months
- Child must be able to attend regular CF clinic visits and any additional study visits if needed
You will not qualify if you...
- Children with malnutrition
- Children requiring nutritional supplementation via any feeding tube
- Children with poorly controlled CF lung disease
- Children with advanced CF liver disease
- Children with comorbid gastrointestinal diseases such as celiac disease, Crohn's disease, or other malabsorptive disorders
- Children with significant food or gastrointestinal allergies
- Family unwilling to adhere to the prescribed dietary intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants follow an exclusive Mediterranean diet to assess its effects on gastrointestinal microbiome, inflammation, symptoms, and nutritional status.
Regular visits during routine CF clinic appointments with additional study visits as needed
Trial Site Locations
Total: 2 locations
1
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Not Yet Recruiting
2
Dartmouth Health Children's
Manchester, New Hampshire, United States, 03104
Actively Recruiting
Research Team
J
Julie L Sanville, MD
S
Sarah P Winslow, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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