Glutamine Supplementation in Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01051999
• Date of registration: 15/01/2010
• Prospective Registration: Yes
• Primary sponsor: Emory University
• Public title: Glutamine Supplementation in Cystic Fibrosis CFG
• Scientific title: Glutamine Supplementation and Immunity in Adults With Cystic Fibrosis
• Date of first enrolment: February 2010
• Target sample size: 17
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01051999
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Immune Function

Cystic Fibrosis

Intervention(s)

Dietary Supplement: L-alanine

Dietary Supplement: Glutamine

Primary Outcome(s)

Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12. [Time Frame: 12 weeks]

Secondary ID(s)

IRB00025564

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Emmaus Medical, Inc.