Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-18
SponsorDartmouth-Hitchcock Medical Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Mediterranean diet

    Other intervention

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: med dietExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

Fecal calprotectin

Fecal calprotectin as a marker of intestinal inflammation. Patient assessment of upper gastrointestinal symptom severity index (PAGI-SYM) for symptom reporting.

Time frame
6 months

Other outcomes

Sponsors and contacts

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Dartmouth-Hitchcock Medical Center

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator