CervicovaginitisBIOMIS-DIMONCT04698109
Establishment of the Human Intestinal and Salivary Microbiota Biobank - Gynecological Diseases
An observational study of Cervicovaginitis and Endometriosis, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial summary
This is a prospective, clinical, monocentric study aimed to collect biological samples and study microbiota from subjects suffering from subjects with recurrent cervicovaginitis, subjects with endometriosis, subjects with repeated implantation failures and from healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cervicovaginitis, Endometriosis, Repeated Implantation Failure
- What is being tested?
- Biological sample collection, Questionnaire and Medical examination
- How many people
- 103 participants
- Where
- 1 siteItaly
- Study dates
- 11 Feb 2021to 8 Apr 2022
- Phase
- Observational
- 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 45 years
- All sexes
- Adult
Study population: Patients with a diagnosis of recurrent cervicovaginitis, of endometriosis and subjects with repeated implantation failures attending to the clinical centres involved in the study. Healthy volunteers will be recruited by invitation. Enrolled subjects must not have any family relationship and hierarchical subordination with the hospitals in which biological samples will be collected.
Who may be able to join
- HEALTHY VOLUNTEERS
- healthy subjects aged between 18 and 45 years, in reproductive age
- BMI between 18.5-30
- omnivorous diet
- signature of the informed consent
- PATIENTS WITH RECIDIVING CERVIC VAGINITIS
Show all 23Show fewer
- healthy subjects aged between 18 and 45 years, in reproductive age
- Patients suffering from at least 3 episodes of relapsing cervicovaginitis per year: diagnosis of anaerobic vaginitis (AV) or bacterial vaginosis (BV) or vulvo-vaginal candidiasis (VVC) based on clinical symptoms and positive microscopic examination and / or positive vaginal culture
- BMI between 18.5-30
- omnivorous diet
- signature of the informed consent
- PATIENTS WITH ENDOMETRIOSIS
- aged between 18 and 45 years, in reproductive age
- patients with endometriosis: diagnosis of endometriosis carried out with transvaginal ultrasound with associated elevation of CA125
- BMI between 18.5-30
- omnivorous diet
- signature of the informed consent
- PATIENTS WITH REPEATED IMPLANT FAILURES (RIF)
- age between 18 and 45 years in reproductive age
- patients with RIF: patients who have followed PMA protocols with at least 3 failed attempts after transfer of good quality embryos
- BMI between 18.5-30
- omnivorous diet
- signature of the informed consent
Who cannot join
- HEALTHY VOLUNTEERS
- Current or previous infectious diseases (HAV, HBV, HCV, HIV, Cytomegalovirus, Epstein-Barr virus)
- HPV positive
- Chronic liver disease
- History of Clostridium difficile infections
- Recent (<3 months) therapy with antibiotics, immunosuppressive drugs, chemotherapy
Show all 55Show fewer
- Chronic therapy with proton pump inhibitors
- Recent (<3 months) use of probiotics, laxatives or other aids (drugs / supplements) for the regulation of gastrointestinal activity
- Previous history of organ / tissue transplantation
- Recent onset of diarrhea
- Chronic diarrhea
- Chronic constipation
- Previous gastrointestinal surgery (eg gastric bypass)
- Recurring urinary tract infections (3 cases per year)
- Previous major acute cardiovascular diseases (myocardial infarction, stroke)
- Type 2 diabetes mellitus
- Hypertension
- eGFR (estimated glomerular filtration rate) lower than 60ml / minute and / or diagnosis of nephropathy
- Chronic gastrointestinal disorders
- Systemic inflammatory diseases
- Suspicion, clinical diagnosis or previous history of cancer (<5 years)
- Autoimmune disorders or history of chronic and systemic autoimmune disorders
- Neurodegenerative disorders
- Pregnancy and breastfeeding
- Hormonal and / or intrauterine contraceptive therapy
- Healthcare workers
- Operators work with animals
- Psychiatric conditions that reduce protocol compliance.
- POPULATION 2 - PATIENTS WITH RECIDIVING CERVIC VAGINITIS/ POPULATION 3 - PATIENTS WITH ENDOMETRIOSIS/ POPULATION 4 - PATIENTS WITH REPEATED IMPLANT FAILURES (RIF)
- Current or previous infectious diseases (HAV, HBV, HCV, HIV, Cytomegalovirus, Epstein-Barr virus)
- Chronic liver disease
- History of Clostridium difficile infections
- Recent (<3 months) therapy with antibiotics, immunosuppressive drugs, chemotherapy
- Chronic therapy with proton pump inhibitors
- Recent (<3 months) use of probiotics, laxatives or other aids (drugs / supplements) for the regulation of gastrointestinal activity
- Previous history of organ / tissue transplantation
- Recent onset of diarrhea
- Chronic diarrhea
- Chronic constipation
- Previous gastrointestinal surgery (eg gastric bypass)
- Recurring urinary tract infections (3 cases per year)
- Previous major acute cardiovascular diseases (myocardial infarction, stroke)
- Type 2 diabetes mellitus
- Hypertension
- eGFR (estimated glomerular filtration rate) lower than 60ml / minute and / or diagnosis of nephropathy
- Chronic gastrointestinal disorders
- Systemic inflammatory diseases
- Suspicion, clinical diagnosis or previous history of cancer (<5 years)
- Autoimmune disorders or history of chronic and systemic autoimmune disorders
- Neurodegenerative disorders
- Pregnancy and breastfeeding
- Hormonal and / or intrauterine contraceptive therapy
- Healthcare workers
- Operators work with animals
- Psychiatric conditions that reduce protocol compliance.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dipartimento di Scienze biomediche e oncologia umana (DIMO), Sezione di Ginecologia ed Ostetricia II Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
Bari
About this study
Official title: Costituzione Della Biobanca Del Microbiota Intestinale e Salivare Umano: Dalla Disbiosi Alla Simbiosi
This is a prospective, clinical, monocentric study aimed to collect biological samples and study microbiota from subjects suffering from subjects with recurrent cervicovaginitis, subjects with endometriosis, subjects with repeated implantation failures and from healthy volunteers. Microbiota is a complex consortium of microorganisms, located at the mucosal level (in particular intestinal, oral and vaginal) having a key role in human health and in the onset of several diseases. Microbiota alterations have been found in several diseases (gastrointestinal, metabolic, renal, oncological, gynaecological).
The study will allow to:
- Provide biological samples (faeces, saliva, vaginal, urine) from healthy volunteers and patients suffering from selected disease to the first Italian microbiota biobank;
- Study microorganisms using different in vitro and in vivo techniques;
- Study the link between the microbiota and the disease. This study is part of the BIOMIS project (Project Code: ARS01_01220), presented as part of the "Avviso per la presentazione di progetti di ricerca industriale e sviluppo sperimentale nelle 12 aree di specializzazione individuate dal PNR 2015-2020" and admitted to funding under the National Operational Program "Ricerca e Innovazione" 2014-2020 by directorial decree of MIUR - Department for Higher Education and Research - n. 2298 of 12 September 2018. BIOMIS includes several clinical studies that enrol patients with different pathologies to collect and store biological samples and study microbiota.
Read the detailed description
The primary aim of this monocentric study is to populate the first national microbioma biobank with biological samples (fecal, salivary, urinary and vaginsl samples) subjects suffering from selected disease disease and healthy volunteers.
The secondary aim is the characterization of microorganisms of the biobank and study of the microbiota-pathology relationship using meta-omics, in vitro and in vivo approaches, The study plans to enrol 100 subjects at Policlinic of Bari, according to the inclusion/exclusion criteria. The study participation is voluntary, and the subjects have the right to withdraw from the study at any time and for any reason.
During the study, 3 visits are planned:
- Visit 0 (V0), including description of the objectives and procedures study, signature written informed consent, inclusion/exclusion criteria evaluation, medical examination (blood pressure measurement, abdominal and thoracic physical examination), filling in of the anamnestic questionnaire, delivery of kits for the collection of fecal, salivary and urinary material to be reported at Visit 1 and delivery of a 3-day food diary, to be completed autonomously in the days preceding the Visit 1.
- Visit 1 (V1) - at least 4 days after V0, including delivery of the of the collected biological material (feces, saliva, urine), and of a 3-day food diary, filling in of the new signs and symptoms anamnestic questionnaire and collection of the vaginal swab by medical staff.
- Telephone evaluation: administration of a "Food Frequency Questionnaire" to assess the subjects' alimentary habits.
Standard Operative Procedures (SOP) for samples storing, transport and processing will be adopted to ensure samples stability and grant results validity and quality.
Following collections, samples will be processed in different aliquots that will be used for:
- routine screening;
- storage in the first Italian human microbiote biobank (I.R.C.C.S. - Istituto Tumori "Giovanni Paolo II", Bari);
- evaluation of the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile.
Furthermore, molecular characterization of pathogenic microorganisms and pathogenic biotypes (pathovars) of commensal species of subjects with selected pathologies will be conducted.
Part of the biological material will be used for animal studies on the physiopathological role of the human intestinal microbiota transplanted into mouse models of pathology and Germ-free mouse models (specific animal study protocol developed).
The study foresees no more than minimal risk associated with blood sampling procedures. All the necessary measures to avoid any risks / inconveniences resulting from participation of the subject under study will be taken.
The study is compliant with Good Clinical Practice. Study protocol and all related documents have been approved by approved by the Independent Ethics Committees (IEC) of the involved clinical sites.
To ensure the protection and confidentiality of the participants' data, all study activities will be carried out in accordance with the European General Data Protection Regulation, Regulation (EU) 2016/679, which repeals Directive 95/46/EC.
- Being tested
- Biological sample collection, Questionnaire, Medical examination
- Keywords
- Microbioma biobank, Biological human samples, genital system disease, Meta-omics approaches, Microbiota-pathology relationship
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample collectionOther
Collection of faeces, urine, saliva, vaginal swab for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
QuestionnaireOther
Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
Medical examinationOther
Blood pressure measurement, abdominal and thoracic physical examination
| Study group | Role | What they receive |
|---|---|---|
| recurrent cervicovaginitis | patients with recurrent cervicovaginitis Receives: Other: Biological sample collection; Other: Questionnaire; Other: Medical examination | |
| endometriosis | patients with endometriosis Receives: Other: Biological sample collection; Other: Questionnaire; Other: Medical examination | |
| repeated implantation failures | patients with repeated implantation failures Receives: Other: Biological sample collection; Other: Questionnaire; Other: Medical examination | |
| healthy volunteers | healthy volunteers Receives: Other: Biological sample collection; Other: Questionnaire; Other: Medical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biological samples collection for establishment of the first National Microbiome Biobank
Recruitment of 100 subjects (patients with recurrent cervicovaginitis, endometriosis, repeated implantation failures and healthy volunteers) to collect biological samples for establishment of the first National Microbiome Biobank
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start11 Feb 2021
- Primary completion8 Apr 2022
- Study completion8 Apr 2022
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 CervicovaginitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies, Istituti Tumori Giovanni Paolo II, University of Bari Aldo Moro, University of Salento
- Responsible party
- Sponsor
- Investigators
- Ettore Cicinelli, Principal investigator, Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698109
- Sponsor's protocol ID
- BIOMIS-DIMO
- Acronym
- BIOMIS-DIMO
- Status last verified
- Jan 2022
- First submitted
- 17 Dec 2020
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma D, Chen Y, Chen T. Vaginal microbiota transplantation for the treatment of bacterial vaginosis: a conceptual analysis. FEMS Microbiol Lett. 2019 Feb 1;366(4):fnz025. doi: 10.1093/femsle/fnz025.
PubMed 30715301Yuan M, Li D, Zhang Z, Sun H, An M, Wang G. Endometriosis induces gut microbiota alterations in mice. Hum Reprod. 2018 Apr 1;33(4):607-616. doi: 10.1093/humrep/dex372.
PubMed 29462324Smith SB, Ravel J. The vaginal microbiota, host defence and reproductive physiology. J Physiol. 2017 Jan 15;595(2):451-463. doi: 10.1113/JP271694. Epub 2016 May 5.
PubMed 27373840Laschke MW, Menger MD. The gut microbiota: a puppet master in the pathogenesis of endometriosis? Am J Obstet Gynecol. 2016 Jul;215(1):68.e1-4. doi: 10.1016/j.ajog.2016.02.036. Epub 2016 Feb 18.
PubMed 26901277
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Costituzione Della Biobanca Del Microbiota Intestinale e Salivare Umano: Dalla Disbiosi Alla Simbiosi
- ClinicalTrials.gov ID
- NCT04698109
- Acronym / sponsor ID
- BIOMIS-DIMO / BIOMIS-DIMO
- Keywords
- Microbioma biobank, Biological human samples, genital system disease, Meta-omics approaches, Microbiota-pathology relationship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Collaborators
- Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies, Istituti Tumori Giovanni Paolo II, University of Bari Aldo Moro, University of Salento
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 8 Apr 2022 (actual)
- Study completion
- 8 Apr 2022 (actual)
- First posted
- 6 Jan 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.
This is a prospective, clinical, monocentric study aimed to collect biological samples and study microbiota from subjects suffering from subjects with recurrent cervicovaginitis, subjects with endometriosis, subjects with repeated implantation failures and from healthy volunteers. Microbiota is a complex consortium of microorganisms, located at the mucosal level (in particular intestinal, oral and vaginal) having a key role in human health and in the onset of several diseases. Microbiota alterations have been found in several diseases (gastrointestinal, metabolic, renal, oncological, gynaecological).
The study will allow to:
- Provide biological samples (faeces, saliva, vaginal, urine) from healthy volunteers and patients suffering from selected disease to the first Italian microbiota biobank;
- Study microorganisms using different in vitro and in vivo techniques;
- Study the link between the microbiota and the disease. This study is part of the BIOMIS project (Project Code: ARS01_01220), presented as part of the "Avviso per la presentazione di progetti di ricerca industriale e sviluppo sperimentale nelle 12 aree di specializzazione individuate dal PNR 2015-2020" and admitted to funding under the National Operational Program "Ricerca e Innovazione" 2014-2020 by directorial decree of MIUR - Department for Higher Education and Research - n. 2298 of 12 September 2018. BIOMIS includes several clinical studies that enrol patients with different pathologies to collect and store biological samples and study microbiota.
Detailed description
The primary aim of this monocentric study is to populate the first national microbioma biobank with biological samples (fecal, salivary, urinary and vaginsl samples) subjects suffering from selected disease disease and healthy volunteers.
The secondary aim is the characterization of microorganisms of the biobank and study of the microbiota-pathology relationship using meta-omics, in vitro and in vivo approaches, The study plans to enrol 100 subjects at Policlinic of Bari, according to the inclusion/exclusion criteria. The study participation is voluntary, and the subjects have the right to withdraw from the study at any time and for any reason.
During the study, 3 visits are planned:
- Visit 0 (V0), including description of the objectives and procedures study, signature written informed consent, inclusion/exclusion criteria evaluation, medical examination (blood pressure measurement, abdominal and thoracic physical examination), filling in of the anamnestic questionnaire, delivery of kits for the collection of fecal, salivary and urinary material to be reported at Visit 1 and delivery of a 3-day food diary, to be completed autonomously in the days preceding the Visit 1.
- Visit 1 (V1) - at least 4 days after V0, including delivery of the of the collected biological material (feces, saliva, urine), and of a 3-day food diary, filling in of the new signs and symptoms anamnestic questionnaire and collection of the vaginal swab by medical staff.
- Telephone evaluation: administration of a "Food Frequency Questionnaire" to assess the subjects' alimentary habits.
Standard Operative Procedures (SOP) for samples storing, transport and processing will be adopted to ensure samples stability and grant results validity and quality.
Following collections, samples will be processed in different aliquots that will be used for:
- routine screening;
- storage in the first Italian human microbiote biobank (I.R.C.C.S. - Istituto Tumori "Giovanni Paolo II", Bari);
- evaluation of the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile.
Furthermore, molecular characterization of pathogenic microorganisms and pathogenic biotypes (pathovars) of commensal species of subjects with selected pathologies will be conducted.
Part of the biological material will be used for animal studies on the physiopathological role of the human intestinal microbiota transplanted into mouse models of pathology and Germ-free mouse models (specific animal study protocol developed).
The study foresees no more than minimal risk associated with blood sampling procedures. All the necessary measures to avoid any risks / inconveniences resulting from participation of the subject under study will be taken.
The study is compliant with Good Clinical Practice. Study protocol and all related documents have been approved by approved by the Independent Ethics Committees (IEC) of the involved clinical sites.
To ensure the protection and confidentiality of the participants' data, all study activities will be carried out in accordance with the European General Data Protection Regulation, Regulation (EU) 2016/679, which repeals Directive 95/46/EC.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| recurrent cervicovaginitis | – | Other: Biological sample collection, Other: Questionnaire, Other: Medical examinationpatients with recurrent cervicovaginitis |
| endometriosis | – | Other: Biological sample collection, Other: Questionnaire, Other: Medical examinationpatients with endometriosis |
| repeated implantation failures | – | Other: Biological sample collection, Other: Questionnaire, Other: Medical examinationpatients with repeated implantation failures |
| healthy volunteers | – | Other: Biological sample collection, Other: Questionnaire, Other: Medical examinationhealthy volunteers |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients with a diagnosis of recurrent cervicovaginitis, of endometriosis and subjects with repeated implantation failures attending to the clinical centres involved in the study. Healthy volunteers will be recruited by invitation. Enrolled subjects must not have any family relationship and hierarchical subordination with the hospitals in which biological samples will be collected.
Key inclusion criteria (23 listed)
- HEALTHY VOLUNTEERS
- healthy subjects aged between 18 and 45 years, in reproductive age
- BMI between 18.5-30
- omnivorous diet
- signature of the informed consent
Key exclusion criteria (55 listed)
- HEALTHY VOLUNTEERS
- Current or previous infectious diseases (HAV, HBV, HCV, HIV, Cytomegalovirus, Epstein-Barr virus)
- HPV positive
- Chronic liver disease
- History of Clostridium difficile infections
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 |
|---|---|---|
| Biological sample collectionCollection of faeces, urine, saliva, vaginal swab for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening | Other | endometriosis, healthy volunteers, recurrent cervicovaginitis, repeated implantation failures |
| QuestionnaireAnamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire | Other | endometriosis, healthy volunteers, recurrent cervicovaginitis, repeated implantation failures |
| Medical examinationBlood pressure measurement, abdominal and thoracic physical examination | Other | endometriosis, healthy volunteers, recurrent cervicovaginitis, repeated implantation failures |
Primary outcome
Biological samples collection for establishment of the first National Microbiome Biobank
Time frame: through study completion, an average of 1 year
Recruitment of 100 subjects (patients with recurrent cervicovaginitis, endometriosis, repeated implantation failures and healthy volunteers) to collect biological samples for establishment of the first National Microbiome Biobank
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Background: PubMed 30715301Ma D, Chen Y, Chen T. Vaginal microbiota transplantation for the treatment of bacterial vaginosis: a conceptual analysis. FEMS Microbiol Lett. 2019 Feb 1;366(4):fnz025. doi: 10.1093/femsle/fnz025.
- Background: PubMed 29462324Yuan M, Li D, Zhang Z, Sun H, An M, Wang G. Endometriosis induces gut microbiota alterations in mice. Hum Reprod. 2018 Apr 1;33(4):607-616. doi: 10.1093/humrep/dex372.
- Background: PubMed 27373840Smith SB, Ravel J. The vaginal microbiota, host defence and reproductive physiology. J Physiol. 2017 Jan 15;595(2):451-463. doi: 10.1113/JP271694. Epub 2016 May 5.
- Background: PubMed 26901277Laschke MW, Menger MD. The gut microbiota: a puppet master in the pathogenesis of endometriosis? Am J Obstet Gynecol. 2016 Jul;215(1):68.e1-4. doi: 10.1016/j.ajog.2016.02.036. Epub 2016 Feb 18.
- Individual participant dataSharing planned: No
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.
Ettore Cicinelli principal investigator
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervicovaginitis and Endometriosis, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
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 23 inclusion and 55 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: finished, as of the sponsor's last update on 4 Aug 2022. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biological samples collection for establishment of the first National Microbiome Biobank (time frame: through study completion, an average of 1 year). 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 NCT04698109, 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 4 Aug 2022.