Post-Acute COVID19 SyndromeFMT-PACSNCT05556733
FMT for Post-acute COVID-19 Syndrome
A study testing Faecal Microbiota Transplantation in people with Post-Acute COVID19 Syndrome and COVID-19, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
In recovered COVID-19 patients, emerging global data have reported the presence of long COVID, that is, at least one symptom that an alternative diagnosis cannot explain has been persistent for four or more weeks after the initial infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Acute COVID19 Syndrome, COVID-19
- What is being tested?
- Faecal Microbiota Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Sep 2022to 30 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 and above
- Subjects who were recovered cases of COVID-19 confirmed by RT-PCR or rapid antigen test (RAT)
- Subjects who had insomnia symptoms of post-acute COVID-19 syndrome at screening visit
Who cannot join
- Confirmed current active malignancy
- Had abdominal surgery
- Known history of severe organ failure (including decompensated cirrhosis), renal failure on dialysis, suffering from human immunodeficiency virus infection;
- Known pregnancy
- Mental retardation or inability to provide informed consent
- Contraindications to upper GI endoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Faecal Microbiota Transplantation for Post-acute COVID-19 Syndrome: a Pilot Open-label Study
In recovered COVID-19 patients, emerging global data have reported the presence of long COVID, that is, at least one symptom that an alternative diagnosis cannot explain has been persistent for four or more weeks after the initial infection. We demonstrated previously that almost 80% of recovered COVID-19 patients in Hong Kong suffer from Long COVID for more than 6 months, affecting multiple body systems.
In a recent study, the five most common Long COVID symptoms were fatigue, memory problem, difficulty sleeping, anxiety and hair loss. One promising hypothesis is the involvement of the gut microbiota, a collection of the trillions of gut microorganisms that play important immunomodulatory roles against infections.
Faecal microbiota transplantation (FMT), which is the infusion of processed faeces from healthy donors to the gut of affected subjects, has shown impressive therapeutic effects for recurrent Clostridioides difficile infection and other emerging indications. Gut microorganisms together with the metabolites in the donated faeces could potentially modulate the gut microbiota of the recipient and treat the dysbiosis associated with pathological health conditions. To date, no study has yet to assess the therapeutic effects of FMT in post-COVID-19 neuropsychiatric conditions.
Read the detailed description
Coronavirus Disease 2019 (COVID-19) is the disease caused by a novel coronavirus SARS- CoV-2. In recovered COVID-19 patients, emerging global data have reported the presence of Long COVID, a condition where at least one symptom that cannot be explained by alternative diagnosis has been persistent for four or more weeks after the initial infection. We demonstrated previously that almost 80% of recovered COVID-19 patients in Hong Kong suffer from Long COVID for more than 6 months, affecting multiple body systems.
In a recent study, the five most common Long COVID symptoms were fatigue, memory problem, difficulty sleeping, anxiety and hair loss. Current treatment for Long COVID only involves symptomatic care, as the exact mechanisms underlying the pathogenesis are still largely unknown. One promising hypothesis is the involvement of the gut microbiota, a collection of the trillions of gut microorganisms that play important immunomodulatory roles against infections. Our recently published findings have shown that patients with Long COVID had a less diverse gut microbiota with significantly fewer health-associated commensal bacteria than those without Long COVID. Previous studies have also proved the association between the gut microbiota and insomnia, circadian disturbance and affective disorders. Thus, gut microbiota modulation could be a novel therapeutic strategy for these neuropsychiatric conditions.
Faecal microbiota transplantation (FMT), which is the infusion of faeces from healthy donors to the gut of affected subjects, has shown impressive therapeutic effects for various diseases. To date, no study has yet to assess the therapeutic effects of FMT in post-COVID-19 neuropsychiatric conditions. In this pilot open-label study, we aim to explore the efficacy of FMT in improving neuropsychiatric symptoms including but not limited to insomnia severity, sleep quality, anxiety and fatigue in recovered COVID-19 patients. FMT will be administrated via Oesophago-gastro-duodenoscopy (OGD) and Flexible Sigmoidoscopy (FS). Two arms will be recruited in a 1:1 ratio. The intervention group will receive FMT while the control group will not receive FMT. Both groups will have the same assessments. Subjects will receive FMT via OGD at week 0, week 2, week 4 and week 8, and via FS at week 0. Final follow-up will be scheduled at weeks 8 and 12 for clinical assessment. To assess the efficacy of FMT in improving neuropsychiatric symptoms, subjects will have to fill in study questionnaires at baseline, week 8 and week 12. Subjects will also be asked to fill in a sleep diary daily until week 12.
- Conditions
- Post-Acute COVID19 Syndrome, COVID-19
- Being tested
- Faecal Microbiota Transplantation
- Keywords
- Faecal Microbiota Transplantation
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal Microbiota TransplantationProcedure or surgery
FMT at baseline, week 2, week 4, week 8
| Study group | Role | What they receive |
|---|---|---|
| Faecal Microbiota Transplantation | Experimental | Subjects will receive Faecal Microbiota Transplantation Receives: Procedure: Faecal Microbiota Transplantation |
| Control | No intervention | The control subjects will not receive FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insomnia severity
Severity of insomnia will be measured by a 7-item Insomnia Severity Index (ISI). ISI is a self-report questionnaire used to evaluate the nature, severity and impact of insomnia. Total score ranges from 0 to 28. Higher score indicates more severe insomnia.
Measured: 12 weeks
Secondary outcomes (11)
Change in sleep quality
Quality of sleep will be measured by a 19-item Pittsburgh Sleep Quality Index (PSQI). PSQI is a self-report questionnaire used to evaluate sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Total score ranges from 0 to 21. Lower score indicates healthier sleep quality.
Measured: 12 weeks
Change in anxiety symptoms
Anxiety symptoms will be assessed by a 7-item Generalised Anxiety Disorder-7 scale (GAD-7). GAD-7 is a widely used diagnostic self-report scale for the screening, diagnosis and severity assessment of anxiety disorder. Total score ranges from 0 to 21. Higher score indicates more severe anxiety.
Measured: 12 weeks
Change in daytime sleepiness
Daytime sleepiness will be measured by a 8-item Epworth Sleepiness Scale (ESS). ESS is a widely used self-report questionnaire used to evaluate daytime sleepiness in the field of sleep medicine. Total score ranges from 0 to 24. Higher score indicates more daytime sleepiness.
Measured: 12 weeks
Change in fatigue symptoms
Fatigue symptoms will be assessed by a 20-item Multidimensional Fatigue Inventory (MFI). MFI is a self-report questionnaire used to evaluate five dimensions of fatigue, including general fatigue, physical fatigue, mental fatigue, reduced motivation and reduced activity. Each dimension has four items. Total score of each dimension ranges from 4 to 20. Higher score indicates more severe fatigue for that dimension.
Measured: 12 weeks
Change in sleep diary parameters
Consensus Sleep Diary (CSD) will be used to record sleep time, wake time and subjective sleeping quality daily. Parameters including sleep onset latency, time awake after sleep onset, total wake time, total sleep time and sleep efficiency will be calculated.
Measured: 12 weeks
Change in gut microbiota composition
Relative abundance of gut bacteria at species level will be assessed by metagenomic analysis.
Measured: 12 weeks
Change in gut microbiota diversity and richness
Species diversity (Shannon index) and richness (number of observed species) will be calculated based on the relative abundance of gut bacteria.
Measured: 12 weeks
Similarity of gut microbiota composition to donor
Engraftment of donor species after intervention will be assessed by the similarity of gut microbiota composition to the donor.
Measured: 12 weeks
Change in blood cytokine profile
Change in blood cytokine profile will be assessed, including levels of interferon gamma, interleukins, leptin, vascular endothelial growth factor, membrane-bound immunoglobulin, and tumour necrosis factor-α etc.
Measured: 12 weeks
Change in blood cortisol
Change in blood cortisol will be assessed
Measured: 12 weeks
Change in Melatonin level
Change in blood melatonin will be assessed
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 posted27 Sep 2022
- Study start28 Sep 2022
- Primary completion13 Sep 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Post-Acute COVID19 SyndromeStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group will receive FMT while the control group will not receive FMT.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siew Chien NG, Chinese University of Hong Kong
- Investigators
- Siew Chien Ng, PhD, FRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556733
- Sponsor's protocol ID
- FMT-PACS
- Acronym
- FMT-PACS
- Status last verified
- Oct 2023
- First submitted
- 18 Aug 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10.
PubMed 33692530Whitaker M, Elliott J, Chadeau-Hyam M, Riley S, Darzi A, Cooke G, Ward H, Elliott P. Persistent COVID-19 symptoms in a community study of 606,434 people in England. Nat Commun. 2022 Apr 12;13(1):1957. doi: 10.1038/s41467-022-29521-z.
PubMed 35413949Tran VT, Porcher R, Pane I, Ravaud P. Course of post COVID-19 disease symptoms over time in the ComPaRe long COVID prospective e-cohort. Nat Commun. 2022 Apr 5;13(1):1812. doi: 10.1038/s41467-022-29513-z.
PubMed 35383197Liu Q, Mak JWY, Su Q, Yeoh YK, Lui GC, Ng SSS, Zhang F, Li AYL, Lu W, Hui DS, Chan PK, Chan FKL, Ng SC. Gut microbiota dynamics in a prospective cohort of patients with post-acute COVID-19 syndrome. Gut. 2022 Mar;71(3):544-552. doi: 10.1136/gutjnl-2021-325989. Epub 2022 Jan 26.
PubMed 35082169Li Y, Hao Y, Fan F, Zhang B. The Role of Microbiome in Insomnia, Circadian Disturbance and Depression. Front Psychiatry. 2018 Dec 5;9:669. doi: 10.3389/fpsyt.2018.00669. eCollection 2018.
PubMed 30568608Allegretti JR, Mullish BH, Kelly C, Fischer M. The evolution of the use of faecal microbiota transplantation and emerging therapeutic indications. Lancet. 2019 Aug 3;394(10196):420-431. doi: 10.1016/S0140-6736(19)31266-8.
PubMed 31379333Khoruts A, Sadowsky MJ. Understanding the mechanisms of faecal microbiota transplantation. Nat Rev Gastroenterol Hepatol. 2016 Sep;13(9):508-16. doi: 10.1038/nrgastro.2016.98. Epub 2016 Jun 22.
PubMed 27329806Lau RI, Su Q, Ching JYL, Lui RN, Chan TT, Wong MTL, Lau LHS, Wing YK, Chan RNY, Kwok HYH, Ho AHY, Tse YK, Cheung CP, Li MKT, Siu WY, Liu C, Lu W, Wang Y, Chiu EOL, Cheong PK, Chan FKL, Ng SC. Fecal Microbiota Transplantation for Sleep Disturbance in Post-acute COVID-19 Syndrome. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2487-2496.e6. doi: 10.1016/j.cgh.2024.06.004. Epub 2024 Jun 20.
PubMed 38908733
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Microbiota Transplantation for Post-acute COVID-19 Syndrome: a Pilot Open-label Study
- ClinicalTrials.gov ID
- NCT05556733
- Acronym / sponsor ID
- FMT-PACS / FMT-PACS
- Conditions
- Post-Acute COVID19 Syndrome, COVID-19
- Keywords
- Faecal Microbiota Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 27 Sep 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.
In recovered COVID-19 patients, emerging global data have reported the presence of long COVID, that is, at least one symptom that an alternative diagnosis cannot explain has been persistent for four or more weeks after the initial infection. We demonstrated previously that almost 80% of recovered COVID-19 patients in Hong Kong suffer from Long COVID for more than 6 months, affecting multiple body systems.
In a recent study, the five most common Long COVID symptoms were fatigue, memory problem, difficulty sleeping, anxiety and hair loss. One promising hypothesis is the involvement of the gut microbiota, a collection of the trillions of gut microorganisms that play important immunomodulatory roles against infections.
Faecal microbiota transplantation (FMT), which is the infusion of processed faeces from healthy donors to the gut of affected subjects, has shown impressive therapeutic effects for recurrent Clostridioides difficile infection and other emerging indications. Gut microorganisms together with the metabolites in the donated faeces could potentially modulate the gut microbiota of the recipient and treat the dysbiosis associated with pathological health conditions. To date, no study has yet to assess the therapeutic effects of FMT in post-COVID-19 neuropsychiatric conditions.
Detailed description
Coronavirus Disease 2019 (COVID-19) is the disease caused by a novel coronavirus SARS- CoV-2. In recovered COVID-19 patients, emerging global data have reported the presence of Long COVID, a condition where at least one symptom that cannot be explained by alternative diagnosis has been persistent for four or more weeks after the initial infection. We demonstrated previously that almost 80% of recovered COVID-19 patients in Hong Kong suffer from Long COVID for more than 6 months, affecting multiple body systems.
In a recent study, the five most common Long COVID symptoms were fatigue, memory problem, difficulty sleeping, anxiety and hair loss. Current treatment for Long COVID only involves symptomatic care, as the exact mechanisms underlying the pathogenesis are still largely unknown. One promising hypothesis is the involvement of the gut microbiota, a collection of the trillions of gut microorganisms that play important immunomodulatory roles against infections. Our recently published findings have shown that patients with Long COVID had a less diverse gut microbiota with significantly fewer health-associated commensal bacteria than those without Long COVID. Previous studies have also proved the association between the gut microbiota and insomnia, circadian disturbance and affective disorders. Thus, gut microbiota modulation could be a novel therapeutic strategy for these neuropsychiatric conditions.
Faecal microbiota transplantation (FMT), which is the infusion of faeces from healthy donors to the gut of affected subjects, has shown impressive therapeutic effects for various diseases. To date, no study has yet to assess the therapeutic effects of FMT in post-COVID-19 neuropsychiatric conditions. In this pilot open-label study, we aim to explore the efficacy of FMT in improving neuropsychiatric symptoms including but not limited to insomnia severity, sleep quality, anxiety and fatigue in recovered COVID-19 patients. FMT will be administrated via Oesophago-gastro-duodenoscopy (OGD) and Flexible Sigmoidoscopy (FS). Two arms will be recruited in a 1:1 ratio. The intervention group will receive FMT while the control group will not receive FMT. Both groups will have the same assessments. Subjects will receive FMT via OGD at week 0, week 2, week 4 and week 8, and via FS at week 0. Final follow-up will be scheduled at weeks 8 and 12 for clinical assessment. To assess the efficacy of FMT in improving neuropsychiatric symptoms, subjects will have to fill in study questionnaires at baseline, week 8 and week 12. Subjects will also be asked to fill in a sleep diary daily until week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group will receive FMT while the control group will not receive FMT.
| Arm | Type | Receives |
|---|---|---|
| Faecal Microbiota Transplantation | Experimental | Procedure: Faecal Microbiota TransplantationSubjects will receive Faecal Microbiota Transplantation |
| Control | No intervention | –The control subjects will not receive FMT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged 18 and above
- Subjects who were recovered cases of COVID-19 confirmed by RT-PCR or rapid antigen test (RAT)
- Subjects who had insomnia symptoms of post-acute COVID-19 syndrome at screening visit
Key exclusion criteria (6 listed)
- Confirmed current active malignancy
- Had abdominal surgery
- Known history of severe organ failure (including decompensated cirrhosis), renal failure on dialysis, suffering from human immunodeficiency virus infection;
- Known pregnancy
- Mental retardation or inability to provide informed consent
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 |
|---|---|---|
| Faecal Microbiota TransplantationFMT at baseline, week 2, week 4, week 8 | Procedure or surgery | Faecal Microbiota Transplantation |
Primary outcome
Change in insomnia severity
Time frame: 12 weeks
Severity of insomnia will be measured by a 7-item Insomnia Severity Index (ISI). ISI is a self-report questionnaire used to evaluate the nature, severity and impact of insomnia. Total score ranges from 0 to 28. Higher score indicates more severe insomnia.
11 secondary outcomes
Change in sleep quality
Time frame: 12 weeks
Change in anxiety symptoms
Time frame: 12 weeks
Change in daytime sleepiness
Time frame: 12 weeks
Change in fatigue symptoms
Time frame: 12 weeks
Change in sleep diary parameters
Time frame: 12 weeks
Change in gut microbiota composition
Time frame: 12 weeks
Change in gut microbiota diversity and richness
Time frame: 12 weeks
Similarity of gut microbiota composition to donor
Time frame: 12 weeks
Change in blood cytokine profile
Time frame: 12 weeks
Change in blood cortisol
Time frame: 12 weeks
Change in Melatonin level
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 33692530Sudre CH, Murray B, Varsavsky T, Graham MS, Penfold RS, Bowyer RC, Pujol JC, Klaser K, Antonelli M, Canas LS, Molteni E, Modat M, Jorge Cardoso M, May A, Ganesh S, Davies R, Nguyen LH, Drew DA, Astley CM, Joshi AD, Merino J, Tsereteli N, Fall T, Gomez MF, Duncan EL, Menni C, Williams FMK, Franks PW, Chan AT, Wolf J, Ourselin S, Spector T, Steves CJ. Attributes and predictors of long COVID. Nat Med. 2021 Apr;27(4):626-631. doi: 10.1038/s41591-021-01292-y. Epub 2021 Mar 10.
- Background: PubMed 35413949Whitaker M, Elliott J, Chadeau-Hyam M, Riley S, Darzi A, Cooke G, Ward H, Elliott P. Persistent COVID-19 symptoms in a community study of 606,434 people in England. Nat Commun. 2022 Apr 12;13(1):1957. doi: 10.1038/s41467-022-29521-z.
- Background: PubMed 35383197Tran VT, Porcher R, Pane I, Ravaud P. Course of post COVID-19 disease symptoms over time in the ComPaRe long COVID prospective e-cohort. Nat Commun. 2022 Apr 5;13(1):1812. doi: 10.1038/s41467-022-29513-z.
- Background: PubMed 35082169Liu Q, Mak JWY, Su Q, Yeoh YK, Lui GC, Ng SSS, Zhang F, Li AYL, Lu W, Hui DS, Chan PK, Chan FKL, Ng SC. Gut microbiota dynamics in a prospective cohort of patients with post-acute COVID-19 syndrome. Gut. 2022 Mar;71(3):544-552. doi: 10.1136/gutjnl-2021-325989. Epub 2022 Jan 26.
- Background: PubMed 30568608Li Y, Hao Y, Fan F, Zhang B. The Role of Microbiome in Insomnia, Circadian Disturbance and Depression. Front Psychiatry. 2018 Dec 5;9:669. doi: 10.3389/fpsyt.2018.00669. eCollection 2018.
- Background: PubMed 31379333Allegretti JR, Mullish BH, Kelly C, Fischer M. The evolution of the use of faecal microbiota transplantation and emerging therapeutic indications. Lancet. 2019 Aug 3;394(10196):420-431. doi: 10.1016/S0140-6736(19)31266-8.
- Background: PubMed 27329806Khoruts A, Sadowsky MJ. Understanding the mechanisms of faecal microbiota transplantation. Nat Rev Gastroenterol Hepatol. 2016 Sep;13(9):508-16. doi: 10.1038/nrgastro.2016.98. Epub 2016 Jun 22.
- Derived from this study: PubMed 38908733Lau RI, Su Q, Ching JYL, Lui RN, Chan TT, Wong MTL, Lau LHS, Wing YK, Chan RNY, Kwok HYH, Ho AHY, Tse YK, Cheung CP, Li MKT, Siu WY, Liu C, Lu W, Wang Y, Chiu EOL, Cheong PK, Chan FKL, Ng SC. Fecal Microbiota Transplantation for Sleep Disturbance in Post-acute COVID-19 Syndrome. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2487-2496.e6. doi: 10.1016/j.cgh.2024.06.004. Epub 2024 Jun 20.
- Individual participant dataSharing planned: No
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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.
Siew Chien Ng, PhD, FRCP principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faecal Microbiota Transplantation in people with Post-Acute COVID19 Syndrome and COVID-19, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 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 31 Oct 2023. 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 Hong Kong. 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?
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?
Change in insomnia severity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05556733, which also lists 8 linked publications.
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 31 Oct 2023.