- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04264923
Evaluation of Stool Microbiome Using HyGIeaCare Prep
Pilot Study: Quality Evaluation of Stool Samples Collected for Microbiome Analysis Using the HyGIeaCare Prep
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Virginia
-
Norfolk, Virginia, Förenta staterna, 78744
- HyGIeaCare Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Microbial classification
Tidsram: 6 months
|
The number of genes present will be counted
|
6 months
|
Diversity between stool and colon effluent samples
Tidsram: 6 months
|
Alpha diversity by Shannon diversity index, presence and number of taxa to be documented
|
6 months
|
Inner diversity of samples
Tidsram: 6 months
|
ANOVA test will be used to acknowledge differences between samples, presence and number of taxa to be documented
|
6 months
|
Contribution of the variables to samples' diversity
Tidsram: 6 months
|
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
|
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Functional genes analysis
Tidsram: 6 months
|
The presence of genes known to represent biochemical functions will be counted and documented
|
6 months
|
Biosynthetic gene clusters
Tidsram: 6 months
|
Groups of genes with known biosynthetic functions and found to be clustered will be counted and documented together in the different samples
|
6 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: David A Johnson, MD, Eastern Virginia Medical School
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- HGP-0002
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på HyGIeaCare Prep
-
University of UlsterNorthern Ireland Chest Heart and StrokeAvslutad
-
Penn State UniversityRekrytering
-
University of WashingtonNational Institute of Allergy and Infectious Diseases (NIAID); Kenyatta...AvslutadHIV-infektioner | GraviditetsrelateradKenya
-
San Diego State UniversityNational Institute of Mental Health (NIMH); Hennepin Healthcare Research...Avslutad
-
Hilary L Surratt, PhDNational Institute on Drug Abuse (NIDA)Aktiv, inte rekryterandeHIV-förebyggandeFörenta staterna
-
University of Illinois at ChicagoNational Institute of Nursing Research (NINR)RekryteringSexarbete | Pre-exponeringsprofylaxFörenta staterna
-
Fred Hutchinson Cancer CenterKenya Medical Research Institute; JhpiegoRekrytering
-
Montefiore Medical CenterNew York State Psychiatric InstituteAktiv, inte rekryterande
-
University of California, San FranciscoNational Institute of Nursing Research (NINR); San Francisco Department...AvslutadHIV/AIDSFörenta staterna
-
University Hospital, Strasbourg, FranceAvslutadHIV-infektion | Sexuellt överförbara sjukdomar | Vaccinationer | Prep receptFrankrike