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Completed

NCT Number: NCT01051999

Glutamine Supplementation in Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Immune Function Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emory University

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glutamine

Dietary Supplement

Oral glutamine powder

L-alanine

Dietary Supplement

L-alanine oral powder

Primary outcomes

  1. Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12.

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Emmaus Medical, Inc.

Registry information

Official study title

Glutamine Supplementation and Immunity in Adults With Cystic Fibrosis

Acronym: CFG

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 20, 2010
Registry last updated
Jan 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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