Glutamine Supplementation in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— CFG  

Official title:

Glutamine Supplementation and Immunity in Adults With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051999
• Other study ID #: IRB00025564
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2010
• Last updated: January 13, 2015
• Start date: February 2010
• Est. completion date: February 2011

Study information

• Verified date: January 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Immune Function

Intervention

Dietary Supplement:
• Glutamine
Oral glutamine powder
• L-alanine
L-alanine oral powder

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Emmaus Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12.		12 weeks	No