- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04264923
Evaluation of Stool Microbiome Using HyGIeaCare Prep
Pilot Study: Quality Evaluation of Stool Samples Collected for Microbiome Analysis Using the HyGIeaCare Prep
Studieoversikt
Detaljert beskrivelse
Patients will have the HyGIeaCare procedure as originally prescribed by their physician. Before and during the procedure stool samples will be collected and sent to a lab for microbiome evaluation.
It is anticipated that stool samples collected from the HyGIeaCare prep will provide more microbiological and biochemical information on the gut interior than using traditional stool samples.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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Virginia
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Norfolk, Virginia, Forente stater, 78744
- HyGIeaCare Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patient's age is between 18 and 80 years old scheduled for elective screening or polyp surveillance indicated colonoscopy
- Patient does not have any known health issues (as listed in exclusion criteria)
- Patient had not taken antibiotics within the last 2 months
Exclusion Criteria:
- Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation), chronic diarrhea or chronic constipation (requiring pharmacologic prescription treatment)
- Patient has secondary constipation (colonic obstruction, medications, metabolic cause)
- Patient has any other condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study
Patient has any of the contraindications listed below:
- Cardiac: Congestive heart failure (NYHA class III or IV or EF <50%)
- GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery, inflammatory bowel disease. History of gastrointestinal surgery- (small bowel, colon. Bariatric surgery)
- GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites
- Abdominal surgery within the last 6 months
- Pregnancy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: All patients enrolled
All patients enrolled with receive the HyGIeaCare Prep with a new lab sampling technique to be used on all patients enrolled in the study.
|
Each patient will have up to 5 stool specimens for evaluation by a lab for microbial contents.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Microbial classification
Tidsramme: 6 months
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The number of genes present will be counted
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6 months
|
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Diversity between stool and colon effluent samples
Tidsramme: 6 months
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Alpha diversity by Shannon diversity index, presence and number of taxa to be documented
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6 months
|
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Inner diversity of samples
Tidsramme: 6 months
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ANOVA test will be used to acknowledge differences between samples, presence and number of taxa to be documented
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6 months
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Contribution of the variables to samples' diversity
Tidsramme: 6 months
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Principal component analysis (PCoA) will be used to mark significant differences between the samples, taxa will be identified by presence, percentage of sample will be documented
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional genes analysis
Tidsramme: 6 months
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The presence of genes known to represent biochemical functions will be counted and documented
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6 months
|
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Biosynthetic gene clusters
Tidsramme: 6 months
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Groups of genes with known biosynthetic functions and found to be clustered will be counted and documented together in the different samples
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6 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: David A Johnson, MD, Eastern Virginia Medical School
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- HGP-0002
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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