HealthyNCT05949411
Development of Non-invasive Methods to Study Gut Microbiome - Nutrition - Host Interactions
A study testing Screening visit, Lactulose test and Administration of standardized meals with characterized dietary fiber content in people with Healthy, run by Université Catholique de Louvain at 3 sites in Belgium.
Trial summary
The aim of this study is to develop and validate an adequate protocol of volatolome (volatile metabolites) measurement in breath of human volunteers (18-65 years) to study gut microbiome - nutrition - host interactions in a general healthy population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Screening visit, Lactulose test and Administration of standardized meals with characterized dietary fiber content
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 Jul 2023to 31 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Woman or man, aged of 18 to 65 years;
- Body mass index (BMI) between 18 and 30 kg/m2;
- Non-smoker;
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Speaking French.
Who cannot join
- Subject with severe systemic disease (renal or hepatic failure, cancer, pancreatic cancer, chronic pancreatitis, asthma …)
- Subject with a history or current chronic/severe gastrointestinal disorder such as duodenal ulcer, chronic colitis, or chronic inflammatory disease of the digestive tract disease (Crohn's disease, ulcerative colitis), celiac disease or irritable bowel syndrome;
- Subjects with a history of digestive tract surgery (except appendectomy);
- Subject who had surgery within the two months prior to the study
- Subjects with psychiatric problems and/or using antipsychotics
- Current or recent (< 4 weeks) intake of antibiotics, fiber supplement, and/or any products modulating gut transit (laxative, anti-diarrheal, ...) or gut microbiota composition; these products will also be avoided for the duration of the study;
Show all 13Show fewer
- Chronic intake of drugs, except contraceptive drug;
- Subject following a low-calorie diet and followed by a doctor or dietician in progress or recently (< 6 weeks);
- Women of childbearing age who are pregnant or breastfeeding or who wish to become pregnant within the next 6 weeks or who are not using an adequate method of contraception (e.g. oral contraception, intrauterine device (IUD), abstinence, ...);
- Subjects who drink more than 3 glasses of alcohol per day (> 30 g of alcohol per day);
- Subjects having participated to another clinical trial two weeks before the screening test visit;
- Subjects who practice an intense sport activity (more than 10 hours per week of intense activity);
- Language barrier, mental or legal incapacity, unwillingness or inability to understand or not being able to participate to the study.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites, 3 recruiting
- Not yet recruiting
Center of Investigation in Clinical Nutrition (CICN), UCLouvain/CICN
Ottignies-Louvain-la-Neuve, Brabant Wallon, 1348
Louise Deldicque, Prof.
- Recruiting
Metabolism and Nutrition research group (MNUT), Louvain Drug Research Institute (LDRI), UCLouvain
Woluwe-Saint-Lambert, Brussels Capital, 1200
Nathalie Delzenne, Prof.
- Recruiting
Testing rooms of Institute of Neuroscience (IONS), UCLouvain/IONS
Woluwe-Saint-Lambert, Brussels Capital, 1200
Louise Deldicque, Prof.
About this study
The aim of this study is to develop and validate an adequate protocol of volatolome (volatile metabolites) measurement in breath of human volunteers (18-65 years) to study gut microbiome - nutrition - host interactions in a general healthy population. For this purpose, breath volatile metabolites (BVM) will be analyzed throughout test days in fasting state and after standardized meals using selected ion flow tube mass spectrometry (SIFT-MS). In addition, gut microbial functions linked notably to hydrogen/methane production, carbohydrates utilization (CAZymes), and in the production of other volatile metabolites of interest (i.e. indole, fatty acid derivatives, ...) will be unraveled through microbiome sequencing data analysis (in silico), metabolomic analyses and measurement of enzymatic activities from saliva, urine and/or fecal samples.
- Conditions
- Healthy
- Being tested
- Screening visit, Lactulose test, Administration of standardized meals with characterized dietary fiber content
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening visitOther
Subjects will be invited to perform the screening visit to sign the informed consent and then to ensure that they are able to participate in this study.
Lactulose testOther
Fasted subjects (at least 10 hours) will receive on oral load of 10 g of lactulose. Then, exhaled H2 will be measured every 30 minutes during 4 hours.
Administration of standardized meals with characterized dietary fiber contentOther
Subjects will receive standardized breakfasts and lunches characterized in terms of dietary fiber content. Urine, saliva, feces samples will be collected. Breath test and gastrointestinal symptoms will be followed during maximum 8h. Subjects will also complete SF36 questionnaire, food diary and stool/transit questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Screening | Other | D-42 to D-7 Receives: Other: Screening visit |
| Lactulose | Other | D0 Receives: Other: Lactulose test |
| Meal 1 | Other | D14+/-7 Receives: Other: Administration of standardized meals with characterized dietary fiber content |
| Meal 2 | Other | D16+/-7 Receives: Other: Administration of standardized meals with characterized dietary fiber content |
| Meal 3 | Other | D18+/-7 Receives: Other: Administration of standardized meals with characterized dietary fiber content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled volatile compounds
Selected Ion flow tube mass spectrometry (SIFT-MS) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Measured: Throughout the entire study, approximately during 24 months
Secondary outcomes (23)
Gut microbiota
Illumina sequencing of 16S ribosomal deoxyribonucleic acid (rDNA), quantitative polymerase chain reaction (PCR)
Measured: Throughout the entire study, approximately during 24 months
Salivary microbiota
Illumina sequencing of 16SrDNA, quantitative PCR
Measured: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - discomfort
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Measured: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - nausea
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Measured: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - bloating
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Measured: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - flatulences
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Measured: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - gastrointestinal reflux
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Measured: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - cramps
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Measured: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - rumbling
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom) - Area under the curve (calculated on 8 hours following breakfast ingestion)
Measured: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - burps
100 mm Visual analog scale (0 = no symptom, 100 = very severe symptom)
Measured: Throughout the entire study, approximately during 24 months
Gut microbiota metabolic capacity
Enzymatic analysis via in-vitro studies, incubation of fecal extracts
Measured: Throughout the entire study, approximately during 24 months
Exhaled hydrogen (H2)
Lactotest 202 - Area under the curve (calculated on 4 hours following lactulose ingestion)
Measured: Throughout the entire study, approximately during 24 months
Exhaled methane (CH4)
Lactotest 202 - Area under the curve (calculated on 8 hours following breakfast ingestion)
Measured: Throughout the entire study, approximately during 24 months
Exhaled carbon dioxide (CO2)
Lactotest 202 - Area under the curve (calculated on 4 hours following lactulose ingestion)
Measured: Throughout the entire study, approximately during 24 months
Carbohydrates utilization - Carbohydrate active enzymes (CAZymes)
Saliva enzymatic activities
Measured: Throughout the entire study, approximately during 24 months
Nutrient intake
Food diary (daily log of what the volunteer eats and drinks each day)
Measured: Throughout the entire study, approximately during 24 months
Dietary habits
Food frequency questionnaire (FFQ) (record the volunteers' usual diet and dietary habits)
Measured: Throughout the entire study, approximately during 24 months
Well-being
The short form (36) health survey (SF36) (0 = worse physical and mental health functioning, 100 = best physical and mental health functioning)
Measured: Throughout the entire study, approximately during 24 months
Transit - frequency
Questionnaire on stool frequency (record each defecation time)
Measured: Throughout the entire study, approximately during 24 months
Transit - type of stool
Bristol stools scale (BSS) (classify the form of feces into 7 categories; type 1 = severe constipation, type 2 = mild constipation, types 3 and 4 = normal, type 5 = lacking fiber, type 6 = mild diarrhea, type 7 = severe diarrhea)
Measured: Throughout the entire study, approximately during 24 months
Transit - ease of passage
5-point Likert's scale (1 = very difficult to defecate, 5 = very easy to defecate)
Measured: Throughout the entire study, approximately during 24 months
Transit - level of emergency
5-point Likert's scale (1 = very urgent need to defecate, 5 = very nonurgent need to defecate)
Measured: Throughout the entire study, approximately during 24 months
Transit - empty feeling
5-point Likert's scale (1 = very nonempty feeling after defecation, 5 = very empty feeling after defecation)
Measured: Throughout the entire study, approximately during 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Delzenne, Prof., Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949411
- Sponsor's protocol ID
- MICROBOOST
- Status last verified
- Jul 2023
- First submitted
- 17 Apr 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared by the partners from the Consortium agreement. * Gut and salivary microbiota composition; * Urinary, salivary and fecal metabolites; * Visual analogue scales data; * Gut microbial functions; * Nutrient intake and dietary habits; * Well-being; * Transit; * Concomitant medication; * Inclusion/exclusion criteria; * Adverse event. Data will be shared at the end of the study.
Publications
Neyrinck AM, Rodriguez J, Zhang Z, Nazare JA, Bindels LB, Cani PD, Maquet V, Laville M, Bischoff SC, Walter J, Delzenne NM. Breath volatile metabolome reveals the impact of dietary fibres on the gut microbiota: Proof of concept in healthy volunteers. EBioMedicine. 2022 Jun;80:104051. doi: 10.1016/j.ebiom.2022.104051. Epub 2022 May 10.
PubMed 35561452Neyrinck AM, Rodriguez J, Zhang Z, Seethaler B, Mailleux F, Vercammen J, Bindels LB, Cani PD, Nazare JA, Maquet V, Laville M, Bischoff SC, Walter J, Delzenne NM. Noninvasive monitoring of fibre fermentation in healthy volunteers by analyzing breath volatile metabolites: lessons from the FiberTAG intervention study. Gut Microbes. 2021 Jan-Dec;13(1):1-16. doi: 10.1080/19490976.2020.1862028.
PubMed 33461385Autuori M, Lengele L, Rombaux M, Dormal V, Deldicque L, Cani PD, Bindels LB, Neyrinck AM, Delzenne NM. Distinction of meal quality and interaction with the gut microbiota by breath volatilome analysis in humans. Gut Microbes. 2026 Dec 31;18(1):2740921. doi: 10.1080/19490976.2026.2740921. Epub 2026 Oct 8.
PubMed 42850732Lengele L, Autuori M, Bosteels E, Neyrinck AM, Rombaux M, Cani PD, Dormal V, Deldicque L, Bindels LB, Delzenne NM. Link between ultra-processed foods and drinks intake, gut microbiota and inflammation: an exploratory analysis in adult volunteers. Nutr J. 2026 May 22;25(1):88. doi: 10.1186/s12937-026-01340-8.
PubMed 42174564
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Non-invasive Methods to Study Gut Microbiome - Nutrition - Host Interactions
- ClinicalTrials.gov ID
- NCT05949411
- Acronym / sponsor ID
- MICROBOOST
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jul 2023 (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 study is to develop and validate an adequate protocol of volatolome (volatile metabolites) measurement in breath of human volunteers (18-65 years) to study gut microbiome - nutrition - host interactions in a general healthy population. For this purpose, breath volatile metabolites (BVM) will be analyzed throughout test days in fasting state and after standardized meals using selected ion flow tube mass spectrometry (SIFT-MS). In addition, gut microbial functions linked notably to hydrogen/methane production, carbohydrates utilization (CAZymes), and in the production of other volatile metabolites of interest (i.e. indole, fatty acid derivatives, ...) will be unraveled through microbiome sequencing data analysis (in silico), metabolomic analyses and measurement of enzymatic activities from saliva, urine and/or fecal samples.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Screening | Other | Other: Screening visitD-42 to D-7 |
| Lactulose | Other | Other: Lactulose testD0 |
| Meal 1 | Other | Other: Administration of standardized meals with characterized dietary fiber contentD14+/-7 |
| Meal 2 | Other | Other: Administration of standardized meals with characterized dietary fiber contentD16+/-7 |
| Meal 3 | Other | Other: Administration of standardized meals with characterized dietary fiber contentD18+/-7 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Woman or man, aged of 18 to 65 years;
- Body mass index (BMI) between 18 and 30 kg/m2;
- Non-smoker;
- Provision of signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
Key exclusion criteria (13 listed)
- Subject with severe systemic disease (renal or hepatic failure, cancer, pancreatic cancer, chronic pancreatitis, asthma …)
- Subject with a history or current chronic/severe gastrointestinal disorder such as duodenal ulcer, chronic colitis, or chronic inflammatory disease of the digestive tract disease (Crohn's disease, ulcerative colitis), celiac disease or irritable bowel syndrome;
- Subjects with a history of digestive tract surgery (except appendectomy);
- Subject who had surgery within the two months prior to the study
- Subjects with psychiatric problems and/or using antipsychotics
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 |
|---|---|---|
| Screening visitSubjects will be invited to perform the screening visit to sign the informed consent and then to ensure that they are able to participate in this study. | Other | Screening |
| Lactulose testFasted subjects (at least 10 hours) will receive on oral load of 10 g of lactulose. Then, exhaled H2 will be measured every 30 minutes during 4 hours. | Other | Lactulose |
| Administration of standardized meals with characterized dietary fiber contentSubjects will receive standardized breakfasts and lunches characterized in terms of dietary fiber content. Urine, saliva, feces samples will be collected. Breath test and gastrointestinal symptoms will be followed during maximum 8h. Subjects will also complete SF36 questionnaire, food diary and stool/transit questionnaire. | Other | Meal 1, Meal 2, Meal 3 |
Primary outcome
Exhaled volatile compounds
Time frame: Throughout the entire study, approximately during 24 months
Selected Ion flow tube mass spectrometry (SIFT-MS) - Area under the curve (calculated on 8 hours following breakfast ingestion)
23 secondary outcomes
Gut microbiota
Time frame: Throughout the entire study, approximately during 24 months
Salivary microbiota
Time frame: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - discomfort
Time frame: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - nausea
Time frame: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - bloating
Time frame: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - flatulences
Time frame: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - gastrointestinal reflux
Time frame: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - cramps
Time frame: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - rumbling
Time frame: Throughout the entire study, approximately during 24 months
Gastrointestinal symptom - burps
Time frame: Throughout the entire study, approximately during 24 months
Gut microbiota metabolic capacity
Time frame: Throughout the entire study, approximately during 24 months
Exhaled hydrogen (H2)
Time frame: Throughout the entire study, approximately during 24 months
Exhaled methane (CH4)
Time frame: Throughout the entire study, approximately during 24 months
Exhaled carbon dioxide (CO2)
Time frame: Throughout the entire study, approximately during 24 months
Carbohydrates utilization - Carbohydrate active enzymes (CAZymes)
Time frame: Throughout the entire study, approximately during 24 months
Nutrient intake
Time frame: Throughout the entire study, approximately during 24 months
Dietary habits
Time frame: Throughout the entire study, approximately during 24 months
Well-being
Time frame: Throughout the entire study, approximately during 24 months
Transit - frequency
Time frame: Throughout the entire study, approximately during 24 months
Transit - type of stool
Time frame: Throughout the entire study, approximately during 24 months
Transit - ease of passage
Time frame: Throughout the entire study, approximately during 24 months
Transit - level of emergency
Time frame: Throughout the entire study, approximately during 24 months
Transit - empty feeling
Time frame: Throughout the entire study, approximately during 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Background: PubMed 35561452Neyrinck AM, Rodriguez J, Zhang Z, Nazare JA, Bindels LB, Cani PD, Maquet V, Laville M, Bischoff SC, Walter J, Delzenne NM. Breath volatile metabolome reveals the impact of dietary fibres on the gut microbiota: Proof of concept in healthy volunteers. EBioMedicine. 2022 Jun;80:104051. doi: 10.1016/j.ebiom.2022.104051. Epub 2022 May 10.
- Background: PubMed 33461385Neyrinck AM, Rodriguez J, Zhang Z, Seethaler B, Mailleux F, Vercammen J, Bindels LB, Cani PD, Nazare JA, Maquet V, Laville M, Bischoff SC, Walter J, Delzenne NM. Noninvasive monitoring of fibre fermentation in healthy volunteers by analyzing breath volatile metabolites: lessons from the FiberTAG intervention study. Gut Microbes. 2021 Jan-Dec;13(1):1-16. doi: 10.1080/19490976.2020.1862028.
- Derived from this study: PubMed 42850732Autuori M, Lengele L, Rombaux M, Dormal V, Deldicque L, Cani PD, Bindels LB, Neyrinck AM, Delzenne NM. Distinction of meal quality and interaction with the gut microbiota by breath volatilome analysis in humans. Gut Microbes. 2026 Dec 31;18(1):2740921. doi: 10.1080/19490976.2026.2740921. Epub 2026 Oct 8.
- Derived from this study: PubMed 42174564Lengele L, Autuori M, Bosteels E, Neyrinck AM, Rombaux M, Cani PD, Dormal V, Deldicque L, Bindels LB, Delzenne NM. Link between ultra-processed foods and drinks intake, gut microbiota and inflammation: an exploratory analysis in adult volunteers. Nutr J. 2026 May 22;25(1):88. doi: 10.1186/s12937-026-01340-8.
- Individual participant dataSharing planned: Yes. All data will be shared by the partners from the Consortium agreement. * Gut and salivary microbiota composition; * Urinary, salivary and fecal metabolites; * Visual analogue scales data; * Gut microbial functions; * Nutrient intake and dietary habits; * Well-being; * Transit; * Concomitant medication; * Inclusion/exclusion criteria; * Adverse event. Data will be shared at the end of the study.
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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.
Nathalie Delzenne, Prof. principal investigator
Université Catholique de Louvain
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening visit, Lactulose test and Administration of standardized meals with characterized dietary fiber content in people with Healthy, run by Université Catholique de Louvain at 3 sites in Belgium.
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 6 inclusion and 13 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 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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 Nathalie Delzenne, Prof. (0032 2 764 73 69, nathalie.delzenne@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exhaled volatile compounds (time frame: Throughout the entire study, approximately during 24 months). 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 NCT05949411, which also lists 4 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 18 Jul 2023.