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New treatment option for Cystic Fibrosis (CF)
Official title Gastrointestinal Response of Pediatric Cystic Fibrosis Patients on Mediterranean Diet
ClinicalTrials.gov ID: NCT07223255
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 18
You may be able to join 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
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lebanon, New Hampshire, United States
- Manchester, New Hampshire, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lebanon, New Hampshire, United States; Manchester, New Hampshire, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.