Cystic Fibrosis, Immune Function
Conditions
Keywords
Glutamine
Brief summary
Patients with cystic fibrosis develop frequent and potentially life-threatening lung infections. Recent studies suggest that the nutrient glutamine may help the body fight off infection. Glutamine is an amino acid; a type of nutrient the body requires to build muscle. It is one of the building blocks of protein. During an illness, blood levels of glutamine tend to be lower than normal. Also, many patients with cystic fibrosis have difficulty getting normal levels of nutrients from food. The aim of this study is to see if patients with cystic fibrosis have low levels of glutamine when they experience an infection, and whether a dietary glutamine supplement taken daily for three months can raise these levels. We also want to see if this supplement can improve other blood markers of immunity (the body's ability to defend itself from infection). We hope to enroll 40 people with cystic fibrosis who experience a lung infection, over a one year period, into this study.
Interventions
DIETARY_SUPPLEMENTGlutamine
Oral glutamine powder
DIETARY_SUPPLEMENTL-alanine
L-alanine oral powder
Sponsors
Emmaus Medical, Inc.
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥ 18 years of age) with cystic fibrosis who give informed consent * Patients must have a clinically diagnosed pulmonary exacerbation at time of enrollment, characterized by clinical requirement for oral or intravenous antibiotics associated with pulmonary symptoms such as increased cough or decreased forced expiratory volumes (FEV1) * Participants must agree to provide phlebotomy samples and complete all study protocol at presentation and at return visits
Exclusion criteria
* Any patients taking specific glutamine supplements within 30 days of enrollment * Pregnant or lactating women * Patients involved in any other research protocol involving intake of a study drug, in the last 60 days. * Patients who are chronically immunosuppressed due to drugs or immunosuppressive illness other than CF (e.g. HIV/AIDS, chronic autoimmune disease) * Patients receiving hemodialysis or with creatinine \>2.5mg/dL * Patients with liver failure from any cause * Patients with a history of cancer within the past 12 months or currently receiving anti-neoplastic therapy. * Patients with a history of seizures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12. | 12 weeks |
Countries
United States
Outcome results
None listed