Glutamine Supplementation in Cystic Fibrosis

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis, Immune Function

In brief

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.

Key facts

Study ID

NCT01051999

Run by

Emory University

People needed

17

Starts

2010-02-01

Expected to finish

2011-02-01

Last updated by the study team

2015-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emory University — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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