Non-Alcoholic Fatty Liver DiseaseICE BATNCT04969744
Impact of Cold Exposure on Metabolic Regulation in Children With Non Alcoholic Fatty Liver Disease (NAFLD)
A study testing ICE in people with Non-Alcoholic Fatty Liver Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this project is to generate pilot data for a grant proposal to evaluate the impact of intermittent cold exposure (ICE) on brown and white adipose tissue (BAT/WAT) function in children with non-alcoholic fatty liver disease (NAFLD). Read more about this study
- Who is it for?
- Ages 8 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- ICE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2021to Dec 2024
- Phase
- Interventional
- 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 8 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Stage 1: Young Adult 16-26 year olds
- Individual must be aged 16-26 years
- Individual who has voluntarily signed informed consent
- Stage 2: Children 8-16 year olds
- Child aged 8-16 years old with NAFLD attending the paediatric clinic at Kings College Hospital
- A control group of children with a BMI z score <1.5 and no diagnosis of liver disease
- Individual willing to participate in the study with informed consent. If the participant is under 16, the parent should provide informed consent.
Who cannot join
- Stage 1: Young Adult 16-26 year olds
- Individual who is thought to be too unwell to participate by the study team, e.g. if participant has a fever or infection requiring treatment with antibiotics.
- Individual who has a medical condition that requires treatment with a drug that could alter BAT function, e.g. thyroid disease (thyroxine, carbimazole, propylthiouracil, beta- blockers), liver disease (ursodeoxycholic acid), any condition requiring treatment with peroxisome proliferator-activated receptor gamma (PPAR-γ) agonists or 4 beta 3 adrenoceptor (β3-AR) agonists.
- Individual has smoked/vaped 5 days before participating in the study.
- Stage 2: Children 8-16 year olds
- Participant who is thought to be too unwell to participate by the study team, e.g. if participant has a fever or infection requiring treatment with antibiotics.
- Individual who has a medical condition that requires treatment with a drug that could alter BAT function, e.g. thyroid disease (thyroxine, carbimazole, propylthiouracil, beta- blockers), liver disease (ursodeoxycholic acid), any condition requiring treatment with peroxisome proliferator-activated receptor gamma (PPAR-γ) agonists or 4 beta 3 adrenoceptor (β3-AR) agonists
- Individual has smoked/vaped 5 days before participating in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Caroline Ovadia, Doctor, 02078486202, caroline.ovadia@kcl.ac.uk
Caroline Ovadia, Doctor
About this study
The aim of this project is to generate pilot data for a grant proposal to evaluate the impact of intermittent cold exposure (ICE) on brown and white adipose tissue (BAT/WAT) function in children with non-alcoholic fatty liver disease (NAFLD). The condition NAFLD is the most common liver disease in both adults and children. There are many emerging drug therapies for NAFLD but at considerable cost in terms of potential side effects. In a mouse model of diet-induced obesity, ICE was shown to help activate BAT, which may help NAFLD and other obesity associated health risks. Given that children have more BAT than adults, we hypothesise that intermittent cold exposure via a cooling vest in children with NAFLD will increase BAT stores or function. We will investigate whether intermittent cold exposure via a cooling vest device will stimulate BAT and also establish whether the cooling vest is acceptable to children and young people. If it is acceptable and has an impact on BAT function this could be a new treatment to reduce the severity of metabolic disorders associated with obesity, particularly fatty liver, e.g. hepatic steatosis. In stage 1, we will investigate the impact of intermittent cold exposure (ICE) on brown and white adipose tissue (BAT/WAT) function in young people aged 16 to 26 years old, as a feasibility study to optimise the cooling process. In stage 2, we will investigate the impact of ICE on BAT and WAT function in 8-16 year olds with non-alcoholic fatty liver disease (NAFLD) and matched controls. Participants will have thermal imaging, MRI scans and provide samples before and after wearing the cooling vest.
Read the detailed description
ICE BAT is a single centre pilot study.
In stage 1, 12 to 24 young people aged 16-26 will be recruited into the study. Participants will use a cooling garment (for 1-2 hours). MRI scans and thermal imaging will be performed before and after ICE to evaluate BAT size and activation. Liver steatosis will be evaluated using MRI Proton Dense Fat Fraction (PDFF). Serum markers of BAT activation and glucose/lipid metabolism will be measured before and after ICE.
In stage 2,12 children with NAFLD and 12 age- and sex-matched controls will be enrolled in the study. In stage 2a, healthy controls will use a cooling garment (for 1-2 hours) and undergo MRI scan and thermal imaging before and after ICE to evaluate BAT size and activation. Liver steatosis will be evaluated using MRI PDFF. In stage 2b the NAFLD patients will be asked to attend for one day and if they are happy to continue, will use a cooling garment (for 1-2 hours/day for a further 4 days). MRI scans and thermal imaging will be performed before and after ICE on day 1 and day 5 to evaluate BAT size and activation. Liver steatosis will be evaluated using MRI PDFF. Serum markers of BAT activation and glucose/lipid metabolism will be measured on day 1 and day 5. Participants with NAFLD, will be asked to give a faecal sample for analysis of their gut microbiome before the study and after day 5 of ICE treatment.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- ICE
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICEDevice
Intermittent Cooling Exposure using cooling garment for 1-2 hours
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Cold Exposure (ICE) | Experimental | Stage 1- healthy volunteers aged 16-26 years will receive ICE for one day. stage 2a - controls aged 8-16 will receive ICE for one day. Stage 2b- NAFLD patients aged 8-16 years will receive ICE for one day or choose to continue for 5 days. Receives: Device: ICE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1: Effectiveness in participants aged 16-26
Assess the ability to deliver ICE via a cooling garment using a probe to measure skin temperature at regular intervals during ICE treatment.
Measured: One day
Stage 1: Acceptability in participants aged 16-26
Acceptability will be measured by the sum of participants' responses to questions 1-5 of the questionnaire. Responses to individual items will also be presented.
Measured: One day
Stage 2: Effectiveness for 8-16 year old participants.
Assess the ability of ICE to deliver cooling, using a probe to measure skin temperature at regular intervals during ICE treatment.
Measured: One to Five days
Stage 2: Acceptability for 8-16 year old participants.
Acceptability of the cooling jacket will be measured by the sum of participants' responses to questions 1-5 of the questionnaire. Responses to individual items will also be presented. Patients will be given the choice as to whether they are willing to attend for 5 days and undergo a further MRI, thermal imaging and blood sampling on day 5.
Measured: One to Five days
Secondary outcomes (23)
Stage 1: BAT dimensions: Measured using MRI before and after ICE.
Measurement of brown adipose tissue depots will be recorded using MRI scans before and after ICE.
Measured: One Day
Stage 1: BAT and WAT function: Assessed using MRI measurements before and after ICE.
Using measures of blood flow, fat fraction and water fraction taken during MRI, analysis analysis algorithms are used to distinguish between BAT and WAT, with blood flow measurements used as a surrogate marker of BAT function.
Measured: One Day
Stage1 : BAT activity: Measured using thermal imaging before and after ICE.
Thermal imaging will be analysed for average temperature of the BAT region of interest and the upper chest area before and after ICE treatment.
Measured: One Day
Stage 1: Acceptability of study protocol and cooling garment: Measured using an acceptability questionnaire at the end of the study.
As above
Measured: One Day
Stage 1: Autonomic function measured by the Empatica E4 device for the duration of the study.
As above
Measured: One Day
Stage 1: Dietary information: Assessed using a 24 hour dietary recall at the beginning of the study day 1.
As above
Measured: One Day
Stage1: Lipid profile: Measured through analysis of blood spot (collected before and after ICE, mandatory) by a secondary laboratory.
As above
Measured: One Day
Stage1: Glucose measured before and after ICE (mandatory).
Glucose measured (in mmol/l) before and after ICE.
Measured: One Day
Stage1: Metabolic hormone profile: Measured before and after ICE (optional).
Metabolic hormones measured before and after ICE, on serum samples by research laboratory.
Measured: One Day
Stage1: Serum lipids measured before and after ICE (optional).
Serum lipids measured before and after ICE (optional) through Viapath Laboratory, King's College Hospital.
Measured: One Day
Stage 2: BAT dimensions measured using MRI before and after ICE.
Measurement of brown adipose tissue depots will be recorded using MRI scans before and after ICE, on day 1 for stage 2a and day 1 and day 5 for stage 2b participants.
Measured: One to Five days
Stage 2: BAT and WAT function assessed using MRI measurements before and after ICE.
Using measures of blood flow, fat fraction and water fraction taken during MRI, analysis analysis algorithms are used to distinguish between BAT and WAT, with blood flow measurements used as a surrogate marker of BAT function.
Measured: One to Five days
Stage 2: Liver fat fraction(proton dense fat fraction (PDFF)): Measured in percentage using MRI before ICE on day 1 for stage 2a and before ICE on day 1 and after ICE on day 5 for stage 2b (PDFF measured using MRI).
As above
Measured: One to Five days
Stage 2: BAT activity: Measured using thermal imaging before and after ICE on day 1 for stage 2a and day 1 and day 5 for stage 2b participants.
As above
Measured: One to Five days
Stage 2: Acceptability of study protocol and cooling garment.
Measure using an acceptability questionnaire at the end of the study. The willingness of the participants to attend for 5 days is also a reflection on the acceptability of the study.
Measured: One to Five days
Stage 2: Autonomic function measured by the Empatica E4 device.
As above
Measured: One to Five days
Stage 2: Activity measured using the Fitbit for NAFLD patients completing 5 days of ICE.
As above
Measured: One to Five days
Stage 2: Dietary information: Assessed using a 24 hour dietary recall, completed at the beginning of study day 1 (and on Day 5 for NAFLD patients who continue to five days).
As above
Measured: One to Five days
Stage 2: Lipid profile: Measured through analysis of blood spot (collected before and after ICE on day 1 for stage 2a and day 1 and day 5 for stage 2b, mandatory) by an external laboratory.
As above.
Measured: One to Five days
Stage 2: Serum lipid measurements before and after ICE (optional)
Serum lipids measured before and after ICE (optional) through Viapath Laboratory, King's College Hospital.
Measured: One to Five days
Stage 2: Metabolic hormone profile before and after ICE (optional).
Metabolic hormones measured before and after ICE, on serum samples by research laboratory.
Measured: One to Five days
Stage 2: Glucose measurements before and after ICE in stage 2 participants
Glucose measurements before and after ICE in mmol/l.
Measured: One to Five days
Stage 2: Gut microbiome evaluation in NAFLD participants (optional).
Bacterial DNA will be isolated from faecal samples to study 16S RNA sequencing.
Measured: One to Five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start23 Oct 2021
- Primary completionMay 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- ICE BAT study will be performed in two stages. In stage 1, we will recruit 12 to 24 healthy volunteers aged between 16-26 years. In stage 2, we will recruit 12 children aged between 8-16 years with NAFLD and 12 age- and sex-matched controls (healthy volunteers).
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Guts UK, Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Caroline Ovadia, Doctor, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969744
- Sponsor's protocol ID
- 278804
- Acronym
- ICE BAT
- Status last verified
- Jan 2024
- First submitted
- 23 Jun 2021
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/A - no plan to share identifiable patient data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cold Exposure on Metabolic Regulation in Children With Non Alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT04969744
- Acronym / sponsor ID
- ICE BAT / 278804
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- King's College London, Guts UK, Medical Research Council
- Study start
- 23 Oct 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Jul 2021 (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.
The aim of this project is to generate pilot data for a grant proposal to evaluate the impact of intermittent cold exposure (ICE) on brown and white adipose tissue (BAT/WAT) function in children with non-alcoholic fatty liver disease (NAFLD). The condition NAFLD is the most common liver disease in both adults and children. There are many emerging drug therapies for NAFLD but at considerable cost in terms of potential side effects. In a mouse model of diet-induced obesity, ICE was shown to help activate BAT, which may help NAFLD and other obesity associated health risks. Given that children have more BAT than adults, we hypothesise that intermittent cold exposure via a cooling vest in children with NAFLD will increase BAT stores or function. We will investigate whether intermittent cold exposure via a cooling vest device will stimulate BAT and also establish whether the cooling vest is acceptable to children and young people. If it is acceptable and has an impact on BAT function this could be a new treatment to reduce the severity of metabolic disorders associated with obesity, particularly fatty liver, e.g. hepatic steatosis. In stage 1, we will investigate the impact of intermittent cold exposure (ICE) on brown and white adipose tissue (BAT/WAT) function in young people aged 16 to 26 years old, as a feasibility study to optimise the cooling process. In stage 2, we will investigate the impact of ICE on BAT and WAT function in 8-16 year olds with non-alcoholic fatty liver disease (NAFLD) and matched controls. Participants will have thermal imaging, MRI scans and provide samples before and after wearing the cooling vest.
Detailed description
ICE BAT is a single centre pilot study.
In stage 1, 12 to 24 young people aged 16-26 will be recruited into the study. Participants will use a cooling garment (for 1-2 hours). MRI scans and thermal imaging will be performed before and after ICE to evaluate BAT size and activation. Liver steatosis will be evaluated using MRI Proton Dense Fat Fraction (PDFF). Serum markers of BAT activation and glucose/lipid metabolism will be measured before and after ICE.
In stage 2,12 children with NAFLD and 12 age- and sex-matched controls will be enrolled in the study. In stage 2a, healthy controls will use a cooling garment (for 1-2 hours) and undergo MRI scan and thermal imaging before and after ICE to evaluate BAT size and activation. Liver steatosis will be evaluated using MRI PDFF. In stage 2b the NAFLD patients will be asked to attend for one day and if they are happy to continue, will use a cooling garment (for 1-2 hours/day for a further 4 days). MRI scans and thermal imaging will be performed before and after ICE on day 1 and day 5 to evaluate BAT size and activation. Liver steatosis will be evaluated using MRI PDFF. Serum markers of BAT activation and glucose/lipid metabolism will be measured on day 1 and day 5. Participants with NAFLD, will be asked to give a faecal sample for analysis of their gut microbiome before the study and after day 5 of ICE treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ICE BAT study will be performed in two stages. In stage 1, we will recruit 12 to 24 healthy volunteers aged between 16-26 years. In stage 2, we will recruit 12 children aged between 8-16 years with NAFLD and 12 age- and sex-matched controls (healthy volunteers).
| Arm | Type | Receives |
|---|---|---|
| Intermittent Cold Exposure (ICE) | Experimental | Device: ICEStage 1- healthy volunteers aged 16-26 years will receive ICE for one day. stage 2a - controls aged 8-16 will receive ICE for one day. Stage 2b- NAFLD patients aged 8-16 years will receive ICE for one day or choose to continue for 5 days. |
Who may qualify
- Ages
- 8 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Stage 1: Young Adult 16-26 year olds
- Individual must be aged 16-26 years
- Individual who has voluntarily signed informed consent
- Stage 2: Children 8-16 year olds
- Child aged 8-16 years old with NAFLD attending the paediatric clinic at Kings College Hospital
Key exclusion criteria (8 listed)
- Stage 1: Young Adult 16-26 year olds
- Individual who is thought to be too unwell to participate by the study team, e.g. if participant has a fever or infection requiring treatment with antibiotics.
- Individual who has a medical condition that requires treatment with a drug that could alter BAT function, e.g. thyroid disease (thyroxine, carbimazole, propylthiouracil, beta- blockers), liver disease (ursodeoxycholic acid), any condition requiring treatment with peroxisome proliferator-activated receptor gamma (PPAR-γ) agonists or 4 beta 3 adrenoceptor (β3-AR) agonists.
- Individual has smoked/vaped 5 days before participating in the study.
- Stage 2: Children 8-16 year olds
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 |
|---|---|---|
| ICEIntermittent Cooling Exposure using cooling garment for 1-2 hours | Device | Intermittent Cold Exposure (ICE) |
Primary outcome
Stage 1: Effectiveness in participants aged 16-26
Time frame: One day
Assess the ability to deliver ICE via a cooling garment using a probe to measure skin temperature at regular intervals during ICE treatment.
Stage 1: Acceptability in participants aged 16-26
Time frame: One day
Acceptability will be measured by the sum of participants' responses to questions 1-5 of the questionnaire. Responses to individual items will also be presented.
Stage 2: Effectiveness for 8-16 year old participants.
Time frame: One to Five days
Assess the ability of ICE to deliver cooling, using a probe to measure skin temperature at regular intervals during ICE treatment.
Stage 2: Acceptability for 8-16 year old participants.
Time frame: One to Five days
Acceptability of the cooling jacket will be measured by the sum of participants' responses to questions 1-5 of the questionnaire. Responses to individual items will also be presented. Patients will be given the choice as to whether they are willing to attend for 5 days and undergo a further MRI, thermal imaging and blood sampling on day 5.
23 secondary outcomes
Stage 1: BAT dimensions: Measured using MRI before and after ICE.
Time frame: One Day
Stage 1: BAT and WAT function: Assessed using MRI measurements before and after ICE.
Time frame: One Day
Stage1 : BAT activity: Measured using thermal imaging before and after ICE.
Time frame: One Day
Stage 1: Acceptability of study protocol and cooling garment: Measured using an acceptability questionnaire at the end of the study.
Time frame: One Day
Stage 1: Autonomic function measured by the Empatica E4 device for the duration of the study.
Time frame: One Day
Stage 1: Dietary information: Assessed using a 24 hour dietary recall at the beginning of the study day 1.
Time frame: One Day
Stage1: Lipid profile: Measured through analysis of blood spot (collected before and after ICE, mandatory) by a secondary laboratory.
Time frame: One Day
Stage1: Glucose measured before and after ICE (mandatory).
Time frame: One Day
Stage1: Metabolic hormone profile: Measured before and after ICE (optional).
Time frame: One Day
Stage1: Serum lipids measured before and after ICE (optional).
Time frame: One Day
Stage 2: BAT dimensions measured using MRI before and after ICE.
Time frame: One to Five days
Stage 2: BAT and WAT function assessed using MRI measurements before and after ICE.
Time frame: One to Five days
Stage 2: Liver fat fraction(proton dense fat fraction (PDFF)): Measured in percentage using MRI before ICE on day 1 for stage 2a and before ICE on day 1 and after ICE on day 5 for stage 2b (PDFF measured using MRI).
Time frame: One to Five days
Stage 2: BAT activity: Measured using thermal imaging before and after ICE on day 1 for stage 2a and day 1 and day 5 for stage 2b participants.
Time frame: One to Five days
Stage 2: Acceptability of study protocol and cooling garment.
Time frame: One to Five days
Stage 2: Autonomic function measured by the Empatica E4 device.
Time frame: One to Five days
Stage 2: Activity measured using the Fitbit for NAFLD patients completing 5 days of ICE.
Time frame: One to Five days
Stage 2: Dietary information: Assessed using a 24 hour dietary recall, completed at the beginning of study day 1 (and on Day 5 for NAFLD patients who continue to five days).
Time frame: One to Five days
Stage 2: Lipid profile: Measured through analysis of blood spot (collected before and after ICE on day 1 for stage 2a and day 1 and day 5 for stage 2b, mandatory) by an external laboratory.
Time frame: One to Five days
Stage 2: Serum lipid measurements before and after ICE (optional)
Time frame: One to Five days
Stage 2: Metabolic hormone profile before and after ICE (optional).
Time frame: One to Five days
Stage 2: Glucose measurements before and after ICE in stage 2 participants
Time frame: One to Five days
Stage 2: Gut microbiome evaluation in NAFLD participants (optional).
Time frame: One to Five days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No. N/A - no plan to share identifiable patient data with other researchers.
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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.
Caroline Ovadia, Doctor principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICE in people with Non-Alcoholic Fatty Liver Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 7 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: status not confirmed, as of the sponsor's last update on 1 Feb 2024. 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 Kingdom. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Caroline Ovadia, Doctor (02078486202, caroline.ovadia@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage 1: Effectiveness in participants aged 16-26 (time frame: One day). The study lists 4 primary outcomes in all. 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 1 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.