- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03388424
Quantification of Microbiota in Health and Diseases (qMHD)
11. september 2020 opdateret af: Luca Gallelli, University of Catanzaro
Microbiota consists of trillions of microorganisms located in all the biological cavity.
The relationships between individual health status and microbiota are based on a sort of "mutual cooperation."
The balance of the microbiota can be compromised by various factors such as environmental, psycho-physical stress, malnutrition (over or low), breastfeeding, chronic diseases, oncology and pharmacological treatments (especially antibiotics and chemotherapics).
The impact of dysbiosis on today's society affects over 70% of the world population
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Intestinal microbiota is defined as the strongest modulator of the human genome and it is considered the "second brain" of our organism for its bi-directional communication with the central nervous system.
Microbiota consists of trillions of microorganisms located in all the biological cavity, In the intestine it is distributed in ecological niches having multiple metabolic activities which influence individual health.
Microbiota acts as barrier against pathogens, regulating the absorption of nutrients, the production of energy and the development of the immune system4.
Intestinal bacteria are generally divided into 4 Phylum: Firmicutes, Actinobacteria, Proteobacteria and Bacteriodetes, in which their proportion shows a correlation with individuals health status.
When in equilibrium among them, these bacteria are essential for the good health of the digestive tract, the good function of immune system and for brain performace.
The relationships between individual health status and microbiota are based on a sort of "mutual cooperation."
The balance of the microbiota can be compromised by various factors such as environmental, psycho-physical stress, malnutrition (over or low), breastfeeding, chronic diseases, oncology and pharmacological treatments (especially antibiotics and chemotherapics).
This disequilibrium leads to altered capability of bacteria to properly extract calories from food affecting the trend of many pathophisilogical status such as obesity, allergic states, inflammatory bowel syndromes cardiovascular diseases, metabolic, oncological and neurodegenerative diseases.
The impact of dysbiosis on today's society affects over 70% of the world population
Undersøgelsestype
Observationel
Tilmelding (Forventet)
120
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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-
Italia
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Catanzaro, Italia, Italien, 88100
- Rekruttering
- AO Materdomini
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
4 år til 90 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Health and disease patients, after a detailed history will be enrolled in one of the six groups and a biological sample will be take for the examination using the n-counter platform.
Beskrivelse
Inclusion Criteria:
- all patients will be enclosed in each group in agreement with the characteristics of the groups
Exclusion Criteria:
- Patients who will not sign the informed consent
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Control
Healthy people of both sex
|
For each group a sample of biological sample will be take and will be analyzed using the n-counter flex platform in order to quantify disbiosis
|
quantification of microbiota in Brain
Patients of both sex with neural disorders and diseases
|
For each group a sample of biological sample will be take and will be analyzed using the n-counter flex platform in order to quantify disbiosis
|
quantification of microbiota in GI
Patients of both sex with gastrointestinal diseases
|
For each group a sample of biological sample will be take and will be analyzed using the n-counter flex platform in order to quantify disbiosis
|
quantification of microbiota in Lung
Patients of both sex with Respiratory diseases
|
For each group a sample of biological sample will be take and will be analyzed using the n-counter flex platform in order to quantify disbiosis
|
quantification of microbiota Metabolic
Patients of both sex with Metabolic Diseases
|
For each group a sample of biological sample will be take and will be analyzed using the n-counter flex platform in order to quantify disbiosis
|
quantification of microbiota in UG
Patients of both sex with Uro-genital Diseases
|
For each group a sample of biological sample will be take and will be analyzed using the n-counter flex platform in order to quantify disbiosis
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Determination of microbiota percentage
Tidsramme: 12 months
|
we will determine the difference of microbiota percentage in diseases-groups respect to control-group
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Determination of antibiotic resistance gene
Tidsramme: 12 months
|
it will be evaluate the presence of antibiotic resistance gene in diseases-group respect to control-group
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12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Luca Gallelli, MD, University of Catanzaro
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
22. november 2017
Primær færdiggørelse (Faktiske)
21. maj 2020
Studieafslutning (Forventet)
21. november 2022
Datoer for studieregistrering
Først indsendt
22. december 2017
Først indsendt, der opfyldte QC-kriterier
22. december 2017
Først opslået (Faktiske)
3. januar 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. september 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. september 2020
Sidst verificeret
1. september 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Microbiota2018
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
data will kept in hospital and results will be published
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med quantification of microbiota
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The Hospital for Sick ChildrenAlliance for International Medical Action; University of N'Djaména, ChadRekrutteringAlvorlig akut underernæringTchad
-
The Second Hospital of Nanjing Medical UniversityAfsluttet
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International Centre for Diarrhoeal Disease Research...Washington University School of MedicineRekruttering
-
University Hospital, GhentResearch Foundation FlandersRekrutteringAfkolonisering af gramnegative multiresistente organismer (MDRO) med donormikrobiota (FMT) (DEKODON)Resistens bakterielBelgien
-
Nanfang Hospital of Southern Medical UniversityUkendtSteroid-refraktær gastrointestinal akut graft versus værtssygdomKina
-
Amin JaverRekrutteringSinus infektion | Bihulebetændelse, kronisk | Sinus infektion kronisk | Sinus sygdomCanada
-
Herbert DuPont, MDLedigTilbagevendende Clostridium Difficile-infektion | Multiresistent Klebsiella Pneumoniae Urinvejsinfektion
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International Centre for Diarrhoeal Disease Research...Washington University School of MedicineUkendtErnæring | Mikrobiota | Supplerende madBangladesh
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Assistance Publique - Hôpitaux de ParisRekrutteringEnterobacteriaceae infektioner | Transplantation af fækal mikrobiotaFrankrig
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Massachusetts General HospitalCenter for Microbiome Informatics and TherapeuticsAktiv, ikke rekrutterendeHepatisk encefalopatiForenede Stater