About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Mediterranean diet
Other interventionPatients enrolled in this study will follow a Mediterranean diet for a 6 month period.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Fecal calprotectin
Fecal calprotectin as a marker of intestinal inflammation. Patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) for symptom reporting.
Sponsors and contacts
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Dartmouth-Hitchcock Medical Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator