Glutamine Supplementation in Cystic Fibrosis

Study Overview
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Brief Summary
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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.

Official Title
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Glutamine Supplementation and Immunity in Adults With Cystic Fibrosis

Conditions
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Cystic Fibrosis, Immune Function

Intervention / Treatment
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* Dietary Supplement: Glutamine
* Dietary Supplement: L-alanine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glutamine<br>Patients randomized to the glutamine arm will receive 0.7g/kg of oral glutamine powder per day | Dietary Supplement: Glutamine<br>* Oral glutamine powder<br>|
| Placebo Comparator: Placebo<br>Patients randomized to the placebo arm will receive 0.7g/kg of oral isonitrogenous L-alanine powder per day | Dietary Supplement: L-alanine<br>* L-alanine oral powder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12. |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glutamine