Brain Injuries, TraumaticEarly Phase 1NCT05569993
Glutamine and Traumatic Brain Injury
A Early Phase 1 study testing Glutamine and Placcebo in people with Brain Injuries, Traumatic, run by Assiut University.
Trial summary
Glutamate is an important neurotransmitter present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system. Glutamate is a non-essential amino acid with restricted passage to the brain from the blood. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Injuries, Traumatic
- What is being tested?
- Glutamine and Placcebo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2022to 30 Dec 2023
- Phase
- Early Phase 1
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 60 years old
- mild to moderate head trauma
Who cannot join
- patients with concurrent cns dysfunction
- Renal failure patient
- diabetic patients with neuropathy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does Glutamine Therapy Have a Positive Effect on Traumatic Brain Injury Patients?Double Blinded Randomized Clinical Trial
Glutamate is an important neurotransmitter present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system.
Glutamate is a non-essential amino acid with restricted passage to the brain from the blood. In the CNS, glutamate is synthesised in neurons as part of the glutamate-glutamine cycle.5,6 so it plays an essential role in normal brain functioning and can improve situations related to impaired cognitive,motor and emotional functions and can be used to improve traumatic brain injury patient general health status
Read the detailed description
The term "brain injury" covers a wide range of conditions and injuries relating to the brain, skull, and scalp. A traumatic brain injury (TBI) usually results when the head or body suffers from a violent blow or jolt that results in swelling, bruising, bleeding, or tearing of the brain tissue which any damage to it has the potential to change the way your body operates.
Now ,(TBI) is considered one of the major causes of disability and deaths ,As It contributes more than 30% Of deaths worldwide . Those who survive a TBI can face effects that last a few days, or the rest of their lives. Effects of TBI can include impaired motor, cognitive and emotional functioning. These issues not only affect individuals but can have lasting effects on families and communities.TBI can also cause some inflammatory mediators to be released in circulation that affect brain and systemic organs such as cortisol,IL6 and TNF etc. A lot of modialities have been introduced to help in decreasing these side effects.
Glutamine,a non-essential amino acid present abundantly throughout the body and is involved in many metabolic processes. It is synthesized from glutamic acid and ammonia. It is the principal carrier of nitrogen in the body and is an important energy source for many cells.glutamine has a restricted passage to the brain from blood but it is synthesised in the brain as a part of the glutamate-glutamine cycle.5,6 so it present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system,maintaining normal brain function and can improve situations related to impaired cognitive,motor and emotional functions.
Hypothesis of this study; Does glutamine therapy have a positive effect on traumatic brain injury patients ?
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Glutamine, Placcebo
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutamineDrug
.3 mg/kg of glutamine
PlacceboOther
Patients will recieve placcebo
| Study group | Role | What they receive |
|---|---|---|
| Glutamine group | Active comparator | 30 patients will recieve .3 mg/kg of glutamine for first 7 days in ICU Receives: Drug: Glutamine |
| Placcebo group | Placebo comparator | 30 patients will recieve placcebo for first 7 days in ICU Receives: Other: Placcebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of ICU stay
The duration of ICU stay after glutamine adiminstration
Measured: First 30 days
Secondary outcomes (2)
Consiousness level by Glagow coma scale
Glasgow coma scale improvement
Measured: 30 days
The incidence of Convulsions
Convulsions controled by glutamine
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start30 Oct 2022 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups will recieve glutamine ,the other will be placcebo group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engy Raafat Youssif, Assiut University
- Investigators
- Mohamed Hassan Bakri, Professor, Study chair, Assiut UniversityEmad Zarief Kamel, Assistant professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569993
- Sponsor's protocol ID
- Traumatic brain injury
- Status last verified
- Oct 2022
- First submitted
- 30 Sep 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Glutamine Therapy Have a Positive Effect on Traumatic Brain Injury Patients?Double Blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05569993
- Acronym / sponsor ID
- Traumatic brain injury
- Conditions
- Brain Injuries, Traumatic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Oct 2022 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 6 Oct 2022 (actual)
- 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.
Glutamate is an important neurotransmitter present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system.
Glutamate is a non-essential amino acid with restricted passage to the brain from the blood. In the CNS, glutamate is synthesised in neurons as part of the glutamate-glutamine cycle.5,6 so it plays an essential role in normal brain functioning and can improve situations related to impaired cognitive,motor and emotional functions and can be used to improve traumatic brain injury patient general health status
Detailed description
The term "brain injury" covers a wide range of conditions and injuries relating to the brain, skull, and scalp. A traumatic brain injury (TBI) usually results when the head or body suffers from a violent blow or jolt that results in swelling, bruising, bleeding, or tearing of the brain tissue which any damage to it has the potential to change the way your body operates.
Now ,(TBI) is considered one of the major causes of disability and deaths ,As It contributes more than 30% Of deaths worldwide . Those who survive a TBI can face effects that last a few days, or the rest of their lives. Effects of TBI can include impaired motor, cognitive and emotional functioning. These issues not only affect individuals but can have lasting effects on families and communities.TBI can also cause some inflammatory mediators to be released in circulation that affect brain and systemic organs such as cortisol,IL6 and TNF etc. A lot of modialities have been introduced to help in decreasing these side effects.
Glutamine,a non-essential amino acid present abundantly throughout the body and is involved in many metabolic processes. It is synthesized from glutamic acid and ammonia. It is the principal carrier of nitrogen in the body and is an important energy source for many cells.glutamine has a restricted passage to the brain from blood but it is synthesised in the brain as a part of the glutamate-glutamine cycle.5,6 so it present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system,maintaining normal brain function and can improve situations related to impaired cognitive,motor and emotional functions.
Hypothesis of this study; Does glutamine therapy have a positive effect on traumatic brain injury patients ?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups will recieve glutamine ,the other will be placcebo group
| Arm | Type | Receives |
|---|---|---|
| Glutamine group | Active comparator | Drug: Glutamine30 patients will recieve .3 mg/kg of glutamine for first 7 days in ICU |
| Placcebo group | Placebo comparator | Other: Placcebo30 patients will recieve placcebo for first 7 days in ICU |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 to 60 years old
- mild to moderate head trauma
Key exclusion criteria (3 listed)
- patients with concurrent cns dysfunction
- Renal failure patient
- diabetic patients with neuropathy
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 |
|---|---|---|
| Glutamine.3 mg/kg of glutamine | Drug | Glutamine group |
| PlacceboPatients will recieve placcebo | Other | Placcebo group |
Primary outcome
The duration of ICU stay
Time frame: First 30 days
The duration of ICU stay after glutamine adiminstration
2 secondary outcomes
Consiousness level by Glagow coma scale
Time frame: 30 days
The incidence of Convulsions
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- https://www.google.com/url?sa=t\&source=web\&rct=j\&url=https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4133642/\&ved=2ahUKEwj6lYmLpb36AhV0hv0HHXvCBlYQFnoECEIQAQ\&usg=AOvVaw1\_kGwGwx5h2G2svqnAp1SJLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed Hassan Bakri, Professor study chair
Assiut University
Emad Zarief Kamel, Assistant professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Glutamine and Placcebo in people with Brain Injuries, Traumatic, run by Assiut University.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Engy Raafat Youssif, Master student (01226016909, Engiraafat95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of ICU stay (time frame: First 30 days). 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 6 Oct 2022.