A Phase 2 interventional study of Glutamine and L-alanine in Cystic Fibrosis and Immune Function, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-14.
Sponsored by Emory University · Phase 2, Interventional, and Prevention
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 17 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized to the glutamine arm will receive 0.7g/kg of oral glutamine powder per day
Dietary Supplement: Glutamine
Patients randomized to the placebo arm will receive 0.7g/kg of oral isonitrogenous L-alanine powder per day
Dietary Supplement: L-alanine
Oral glutamine powder
L-alanine oral powder
Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12.
Time frame: 12 weeks
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Emory University