Gastroesophageal Reflux DiseaseNCT04255693
Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence
A study testing diet adherence, No diet adherence and Change in physical activity in people with Gastroesophageal Reflux Disease and GERD, run by Federal State Budgetary Scientific Institution at 1 site in Russia.
Trial summary
This study is aimed to investigate the role of long-term diet adherence on manifestations of gastroesophageal reflux disease Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, GERD, Gastroesophageal Erosion
- What is being tested?
- diet adherence, No diet adherence and Change in physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 31 Jan 2020to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- willingness to participate (based on the signed informed consent form);
- presence of gastroesophageal reflux disease, based on the following: a) typical symptoms, like heartburn and/or regurgitation (for primary selection, symptoms should be present at least weekly, be actual for at least 3 months prior to the enrolment, and the patient should report the history of symptoms which lasts for at least 6 months); b) previous response to the intake of proton pump inhibitors; c) data of 24-hours oesophageal pH-impedance monitoring with detected pathological gastroesophageal reflux according to the Lyon consensus definitions;
Who cannot join
- pregnant or breast-feeding females;
- abdominal or chest surgery (except appendectomy or cholecystectomy in case they are not followed by adhesive disease of the abdominal organs);
- constant use of non-steroidal anti-inflammatory agents (NSAIDs), sporadic use of NSAIDs will be allowed in case the course of treatment was discontinued at least 2 weeks prior to the enrolment, in case that constant use of NSAIDs happen to be necessary after the enrolment, the patients may continue in the study but doses, frequency and duration of treatment should be carefully documented;
- history or current evidence of cancer of any aetiology and location besides skin cancer in situ successfully treated before the enrolment;
- severe patient's conditions which may lead to misinterpretation of data, or in case of patient's enrolment may put him at risk of exacerbation of co-morbid conditions, or in cases when on discretion of the investigator patient's condition would not allow him to complete the course of the observation. These conditions include, but not limited to: heart failure (class III-IV by NYHA), uncontrolled hypertension, severe neurological disorders, decompensated liver cirrhosis (Child-Pugh B or C), severe depression or other psychological disorders;
- the patient may stop his participation in the study at any time by informing the site personal about his/her decision to withdraw the consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Moscow, 115446
Sergey Morozov, MD, PhD, +79104681801, morosoffsv@mail.ru
Vasily Kropochev, +74997943572, followkropochev@yandex.ru
About this study
This study is aimed to investigate the role of long-term diet adherence on manifestations of gastroesophageal reflux disease
Read the detailed description
The role of diet in the treatment of gastroesophageal reflux disease (GERD) is still under discussion. Some studies support the evidence that specific components of food plays a role in triggering symptoms or may have an impact on reflux oesophagitis. Still, only limited data are present on the long-term real-life effects of diet and behaviour on the disease manifestations and outcomes. This specific study aims to investigate the role of diet in real-life cohort of patients in whom diagnosis of GERD is initially confirmed with the use of modern techniques (questionnaires, endoscopy, oesophageal pH-impedance recordings). To make the study possible, it is planned to form a cohort of patients with different manifestations of gastroesophageal reflux disease: non-erosive GERD (NERD), reflux-oesophagitis (EE), hypersensitive oesophagus. Each form of GERD is to be established in accordance to modern concept of GERD (i.e. Lyon consensus). In addition to standard-of-care examinations, diet assessment will be performed with the use of computer-based food frequency questionnaire (FFQ), which allows to analyse frequently used foods, food products in terms of frequency of consumption and sizes of the portions. Assessment of diet will be performed at the enrolment and than with a period of three months during three years. Based on the results, it would be possible to assess the effect of long-term adherence to diet, change of the composition of it, and perform a multifactorial statistical analysis with the consideration of other confounders: change in BMI, physical activity, smoking, concomitant medications, etc.
- Conditions
- Gastroesophageal Reflux Disease, GERD, Gastroesophageal Erosion, Erosive Esophagitis, Non-erosive Reflux Disease, Non-Erosive Gastro-Esophageal Reflux Disease
- Being tested
- diet adherence, No diet adherence, Change in physical activity, No change in physical activity, Use of antisecretory agents
- Keywords
- GERD, NERD, erosive esophagitis, diet, food, adherence, influence
- Medical subject headings
- Gastroesophageal Reflux, Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet adherenceBehavioural
This type of "intervention" is to be established in a-posteriori analysis by the assessment of a fact whether a subject kept to use his "usual" diet or it contained substantial changes.
No diet adherenceBehavioural
A-posteriori established "intervention" based on the examinations at the end-point
Change in physical activityBehavioural
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data
No change in physical activityBehavioural
The changes in physical activity will be assessed a-posteriori based on the examination at the end-point and comparison to the baseline data
Use of antisecretory agentsBehavioural
This "intervention" will be established a-posteriori, based on the examination at the end-point and compared to the baseline data. The need for the use of anti-secretory agents depends on the form of GERD and will be on the treating physician discretion. It is principal to account the use of anti-secretory agents (H2-histamine receptors blockers, proton pump inhibitors) as a major factors that may influence the outcomes.
No use of antisecretory agentsBehavioural
This "intervention" will be established a-posteriori, based on the examination at the end-point and compared to the baseline data.
| Study group | Role | What they receive |
|---|---|---|
| Change in disease manifestations | Experimental | The data of all the patients will be assessed from the viewpoint of changes in the disease flow (severity and frequency of symptoms, grade of oesophagitis). They will be compared to the changes of the major factors that could influence the disease flow: adherence to anti-secretory agents, presence of concomitant medications and their doses, adherence to diet, change in physical activity. These will be compared to the initial data. Thus, it would be possible to make a multivariate comparison and try to establish the influence (and, possibly, weight) of each of the con-founder on the disease flow. Receives: Behavioral: diet adherence; Behavioral: No diet adherence; Behavioral: Change in physical activity; Behavioral: No change in physical activity; Behavioral: Use of antisecretory agents; Behavioral: No use of antisecretory agents |
| No change in disease flow | Active comparator | To this arm patients with no change in the disease manifestations will be assigned, based on the end-point evaluation. The same as in the "experimental" groups factors will be analysed to establish the difference. Receives: Behavioral: diet adherence; Behavioral: No diet adherence; Behavioral: Change in physical activity; Behavioral: No change in physical activity; Behavioral: Use of antisecretory agents; Behavioral: No use of antisecretory agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heartburn frequency
Number of days a week when the symptom is present
Measured: a week
Heartburn severity
Subjective description reported by the patient, assessed with the use of visual analogue scale, from 0 to 5, where 0 is "not at all severe" and 5 is "very severe"
Measured: a day
Grade of erosive oesophagitis
Grade of oesophagitis will be assessed according to the Los-Angeles classification
Measured: at the end-point, 2 years after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start31 Jan 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- According to the initial assessment, the patients will be allocated to the following subgroups: NERD, Erosive oesophagitis, hypersensitive oesophagus. Each patient will be provided with the standard recommendations on the diet and physical activity according to the initial assessment (calculated energy expenditures, physical activity, physical status and body composition) in addition to the standard drug treatment. Repeated examinations will be performed to assess the disease status and change (if any) of diet.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sergey Morozov, Federal State Budgetary Scientific Institution
- Investigators
- Sergey Morozov, MD, PhD, Principal investigator, Federal State Budgetary Scientific Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255693
- Sponsor's protocol ID
- RLS-GERD
- Status last verified
- Aug 2025
- First submitted
- 2 Feb 2020
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participants data may be shared by request. Patients personal data (name, contacts, etc) will be blinded beforehand, according to the law.
Publications
Gyawali CP, Kahrilas PJ, Savarino E, Zerbib F, Mion F, Smout AJPM, Vaezi M, Sifrim D, Fox MR, Vela MF, Tutuian R, Tack J, Bredenoord AJ, Pandolfino J, Roman S. Modern diagnosis of GERD: the Lyon Consensus. Gut. 2018 Jul;67(7):1351-1362. doi: 10.1136/gutjnl-2017-314722. Epub 2018 Feb 3.
PubMed 29437910Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
PubMed 16928254Savarino E, Bredenoord AJ, Fox M, Pandolfino JE, Roman S, Gyawali CP; International Working Group for Disorders of Gastrointestinal Motility and Function. Expert consensus document: Advances in the physiological assessment and diagnosis of GERD. Nat Rev Gastroenterol Hepatol. 2017 Nov;14(11):665-676. doi: 10.1038/nrgastro.2017.130. Epub 2017 Sep 27.
PubMed 28951582Roman S, Gyawali CP, Savarino E, Yadlapati R, Zerbib F, Wu J, Vela M, Tutuian R, Tatum R, Sifrim D, Keller J, Fox M, Pandolfino JE, Bredenoord AJ; GERD consensus group. Ambulatory reflux monitoring for diagnosis of gastro-esophageal reflux disease: Update of the Porto consensus and recommendations from an international consensus group. Neurogastroenterol Motil. 2017 Oct;29(10):1-15. doi: 10.1111/nmo.13067. Epub 2017 Mar 31.
PubMed 28370768Commisso A, Lim F. Lifestyle Modifications in Adults and Older Adults With Chronic Gastroesophageal Reflux Disease (GERD). Crit Care Nurs Q. 2019 Jan/Mar;42(1):64-74. doi: 10.1097/CNQ.0000000000000239.
PubMed 30507666Martinucci I, Natilli M, Lorenzoni V, Pappalardo L, Monreale A, Turchetti G, Pedreschi D, Marchi S, Barale R, de Bortoli N. Gastroesophageal reflux symptoms among Italian university students: epidemiology and dietary correlates using automatically recorded transactions. BMC Gastroenterol. 2018 Jul 17;18(1):116. doi: 10.1186/s12876-018-0832-9.
PubMed 30016938
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Study of Changes of Gastroesophageal Reflux Disease Manifestations Due to Behavioural and Diet Adherence
- ClinicalTrials.gov ID
- NCT04255693
- Acronym / sponsor ID
- RLS-GERD
- Conditions
- Gastroesophageal Reflux Disease, GERD, Gastroesophageal Erosion, Erosive Esophagitis, Non-erosive Reflux Disease, Non-Erosive Gastro-Esophageal Reflux Disease
- Keywords
- GERD, NERD, erosive esophagitis, diet, food, adherence, influence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Federal State Budgetary Scientific InstitutionOther government
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Feb 2020 (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.
This study is aimed to investigate the role of long-term diet adherence on manifestations of gastroesophageal reflux disease
Detailed description
The role of diet in the treatment of gastroesophageal reflux disease (GERD) is still under discussion. Some studies support the evidence that specific components of food plays a role in triggering symptoms or may have an impact on reflux oesophagitis. Still, only limited data are present on the long-term real-life effects of diet and behaviour on the disease manifestations and outcomes. This specific study aims to investigate the role of diet in real-life cohort of patients in whom diagnosis of GERD is initially confirmed with the use of modern techniques (questionnaires, endoscopy, oesophageal pH-impedance recordings). To make the study possible, it is planned to form a cohort of patients with different manifestations of gastroesophageal reflux disease: non-erosive GERD (NERD), reflux-oesophagitis (EE), hypersensitive oesophagus. Each form of GERD is to be established in accordance to modern concept of GERD (i.e. Lyon consensus). In addition to standard-of-care examinations, diet assessment will be performed with the use of computer-based food frequency questionnaire (FFQ), which allows to analyse frequently used foods, food products in terms of frequency of consumption and sizes of the portions. Assessment of diet will be performed at the enrolment and than with a period of three months during three years. Based on the results, it would be possible to assess the effect of long-term adherence to diet, change of the composition of it, and perform a multifactorial statistical analysis with the consideration of other confounders: change in BMI, physical activity, smoking, concomitant medications, etc.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- According to the initial assessment, the patients will be allocated to the following subgroups: NERD, Erosive oesophagitis, hypersensitive oesophagus. Each patient will be provided with the standard recommendations on the diet and physical activity according to the initial assessment (calculated energy expenditures, physical activity, physical status and body composition) in addition to the standard drug treatment. Repeated examinations will be performed to assess the disease status and change (if any) of diet.
| Arm | Type | Receives |
|---|---|---|
| Change in disease manifestations | Experimental | Behavioral: diet adherence, Behavioral: No diet adherence, Behavioral: Change in physical activity, Behavioral: No change in physical activity, Behavioral: Use of antisecretory agents, Behavioral: No use of antisecretory agentsThe data of all the patients will be assessed from the viewpoint of changes in the disease flow (severity and frequency of symptoms, grade of oesophagitis). They will be compared to the changes of the major factors that could influence the disease flow: adherence to anti-secretory agents, presence of concomitant medications and their doses, adherence to diet, change in physical activity. These will be compared to the initial data. Thus, it would be possible to make a multivariate comparison and try to establish the influence (and, possibly, weight) of each of the con-founder on the disease flow. |
| No change in disease flow | Active comparator | Behavioral: diet adherence, Behavioral: No diet adherence, Behavioral: Change in physical activity, Behavioral: No change in physical activity, Behavioral: Use of antisecretory agents, Behavioral: No use of antisecretory agentsTo this arm patients with no change in the disease manifestations will be assigned, based on the end-point evaluation. The same as in the "experimental" groups factors will be analysed to establish the difference. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- willingness to participate (based on the signed informed consent form);
- presence of gastroesophageal reflux disease, based on the following: a) typical symptoms, like heartburn and/or regurgitation (for primary selection, symptoms should be present at least weekly, be actual for at least 3 months prior to the enrolment, and the patient should report the history of symptoms which lasts for at least 6 months); b) previous response to the intake of proton pump inhibitors; c) data of 24-hours oesophageal pH-impedance monitoring with detected pathological gastroesophageal reflux according to the Lyon consensus definitions;
Key exclusion criteria (6 listed)
- pregnant or breast-feeding females;
- abdominal or chest surgery (except appendectomy or cholecystectomy in case they are not followed by adhesive disease of the abdominal organs);
- constant use of non-steroidal anti-inflammatory agents (NSAIDs), sporadic use of NSAIDs will be allowed in case the course of treatment was discontinued at least 2 weeks prior to the enrolment, in case that constant use of NSAIDs happen to be necessary after the enrolment, the patients may continue in the study but doses, frequency and duration of treatment should be carefully documented;
- history or current evidence of cancer of any aetiology and location besides skin cancer in situ successfully treated before the enrolment;
- severe patient's conditions which may lead to misinterpretation of data, or in case of patient's enrolment may put him at risk of exacerbation of co-morbid conditions, or in cases when on discretion of the investigator patient's condition would not allow him to complete the course of the observation. These conditions include, but not limited to: heart failure (class III-IV by NYHA), uncontrolled hypertension, severe neurological disorders, decompensated liver cirrhosis (Child-Pugh B or C), severe depression or other psychological disorders;
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 |
|---|---|---|
| diet adherenceThis type of "intervention" is to be established in a-posteriori analysis by the assessment of a fact whether a subject kept to use his "usual" diet or it contained substantial changes. | Behavioural | Change in disease manifestations, No change in disease flow |
| No diet adherenceA-posteriori established "intervention" based on the examinations at the end-point | Behavioural | Change in disease manifestations, No change in disease flow |
| Change in physical activityThe changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data | Behavioural | Change in disease manifestations, No change in disease flow |
| No change in physical activityThe changes in physical activity will be assessed a-posteriori based on the examination at the end-point and comparison to the baseline data | Behavioural | Change in disease manifestations, No change in disease flow |
| Use of antisecretory agentsThis "intervention" will be established a-posteriori, based on the examination at the end-point and compared to the baseline data. The need for the use of anti-secretory agents depends on the form of GERD and will be on the treating physician discretion. It is principal to account the use of anti-secretory agents (H2-histamine receptors blockers, proton pump inhibitors) as a major factors that may influence the outcomes. | Behavioural | Change in disease manifestations, No change in disease flow |
| No use of antisecretory agentsThis "intervention" will be established a-posteriori, based on the examination at the end-point and compared to the baseline data. | Behavioural | Change in disease manifestations, No change in disease flow |
Primary outcome
Heartburn frequency
Time frame: a week
Number of days a week when the symptom is present
Heartburn severity
Time frame: a day
Subjective description reported by the patient, assessed with the use of visual analogue scale, from 0 to 5, where 0 is "not at all severe" and 5 is "very severe"
Grade of erosive oesophagitis
Time frame: at the end-point, 2 years after enrolment
Grade of oesophagitis will be assessed according to the Los-Angeles classification
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Background: PubMed 29437910Gyawali CP, Kahrilas PJ, Savarino E, Zerbib F, Mion F, Smout AJPM, Vaezi M, Sifrim D, Fox MR, Vela MF, Tutuian R, Tack J, Bredenoord AJ, Pandolfino J, Roman S. Modern diagnosis of GERD: the Lyon Consensus. Gut. 2018 Jul;67(7):1351-1362. doi: 10.1136/gutjnl-2017-314722. Epub 2018 Feb 3.
- Background: PubMed 16928254Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
- Background: PubMed 28951582Savarino E, Bredenoord AJ, Fox M, Pandolfino JE, Roman S, Gyawali CP; International Working Group for Disorders of Gastrointestinal Motility and Function. Expert consensus document: Advances in the physiological assessment and diagnosis of GERD. Nat Rev Gastroenterol Hepatol. 2017 Nov;14(11):665-676. doi: 10.1038/nrgastro.2017.130. Epub 2017 Sep 27.
- Background: PubMed 28370768Roman S, Gyawali CP, Savarino E, Yadlapati R, Zerbib F, Wu J, Vela M, Tutuian R, Tatum R, Sifrim D, Keller J, Fox M, Pandolfino JE, Bredenoord AJ; GERD consensus group. Ambulatory reflux monitoring for diagnosis of gastro-esophageal reflux disease: Update of the Porto consensus and recommendations from an international consensus group. Neurogastroenterol Motil. 2017 Oct;29(10):1-15. doi: 10.1111/nmo.13067. Epub 2017 Mar 31.
- Background: PubMed 30507666Commisso A, Lim F. Lifestyle Modifications in Adults and Older Adults With Chronic Gastroesophageal Reflux Disease (GERD). Crit Care Nurs Q. 2019 Jan/Mar;42(1):64-74. doi: 10.1097/CNQ.0000000000000239.
- Background: PubMed 30016938Martinucci I, Natilli M, Lorenzoni V, Pappalardo L, Monreale A, Turchetti G, Pedreschi D, Marchi S, Barale R, de Bortoli N. Gastroesophageal reflux symptoms among Italian university students: epidemiology and dietary correlates using automatically recorded transactions. BMC Gastroenterol. 2018 Jul 17;18(1):116. doi: 10.1186/s12876-018-0832-9.
- Individual participant dataSharing planned: Yes. Deidentified individual participants data may be shared by request. Patients personal data (name, contacts, etc) will be blinded beforehand, according to the law.
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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.
Sergey Morozov, MD, PhD principal investigator
Federal State Budgetary Scientific Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet adherence, No diet adherence and Change in physical activity in people with Gastroesophageal Reflux Disease and GERD, run by Federal State Budgetary Scientific Institution at 1 site in Russia.
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 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: looking for participants now, as of the sponsor's last update on 3 Aug 2025. 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 Russia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergey Morozov, MD, PhD (+74996131091, morosoffsv@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heartburn frequency (time frame: a week). The study lists 3 primary outcomes in all. 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 NCT04255693, which also lists 6 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 3 Aug 2025.