Cystic FibrosisPhase 2CFGNCT01051999
Glutamine Supplementation in Cystic Fibrosis
A Phase 2 study testing Glutamine and L-alanine in people with Cystic Fibrosis and Immune Function, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Immune Function
- What is being tested?
- Glutamine and L-alanine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Feb 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glutamine Supplementation and Immunity in Adults With 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.
- Conditions
- Cystic Fibrosis, Immune Function
- Being tested
- Glutamine, L-alanine
- Keywords
- Glutamine
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDietary supplement
Oral glutamine powder
L-alanineDietary supplement
L-alanine oral powder
| Study group | Role | What they receive |
|---|---|---|
| Glutamine | Experimental | Patients randomized to the glutamine arm will receive 0.7g/kg of oral glutamine powder per day Receives: Dietary Supplement: Glutamine |
| Placebo | Placebo comparator | Patients randomized to the placebo arm will receive 0.7g/kg of oral isonitrogenous L-alanine powder per day Receives: Dietary Supplement: L-alanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Emmaus Medical, Inc.
- Responsible party
- Principal investigator, Thomas R. Ziegler, MD, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051999
- Sponsor's protocol ID
- IRB00025564
- Acronym
- CFG
- Status last verified
- Jan 2015
- First submitted
- 15 Jan 2010
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutamine Supplementation and Immunity in Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01051999
- Acronym / sponsor ID
- CFG / IRB00025564
- Conditions
- Cystic Fibrosis, Immune Function
- Keywords
- Glutamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Emmaus Medical, Inc.
- Study start
- Feb 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glutamine | Experimental | Dietary Supplement: GlutaminePatients randomized to the glutamine arm will receive 0.7g/kg of oral glutamine powder per day |
| Placebo | Placebo comparator | Dietary Supplement: L-alaninePatients randomized to the placebo arm will receive 0.7g/kg of oral isonitrogenous L-alanine powder per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlutamineOral glutamine powder | Dietary supplement | Glutamine |
| L-alanineL-alanine oral powder | Dietary supplement | Placebo |
Primary outcome
Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glutamine and L-alanine in people with Cystic Fibrosis and Immune Function, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent increase in plasma glutamine and glutathione redox levels measured at weeks 0, 4, 8, and 12. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2015; AzTrials last refreshed its copy on 6 Nov 2026.