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Clinical trialNCT01194687CompletedObservational

Reproducibility of a Fecal Occult Blood Test Device for Gut Microbiota Analyses

SponsorNational Cancer Institute (NCI)Enrollment98Normal Physiology
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Background: \- Bacteria and other micro-organisms in the intestines play important roles in immunity and other health conditions. As a result, these micro-organisms are likely to affect many health conditions, including several types of cancer. Because cancer and other diseases may affect the digestive system and the bacteria within it, fecal samples that are taken both before and after the onset of a disease may show important changes in the body and provide information about possible treatments. However, unlike repositories of blood and tissue samples, researchers do not have a repository of fecal specimens. Researchers are interested in determining whether standard collection procedures used for fecal occult blood testing can provide accurate information on micro-organisms in the intestine. Objectives: \- To determine whether standard fecal occult blood testing procedures can provide accurate collections of fecal micro-organisms for research purposes. Eligibility: \- Healthy volunteers at least 18 years of age. Design: * At the clinical center, participants will be provided with written and illustrated instructions for the collection procedures and a self-administered risk questionnaire. The questionnaire will assess the challenges of collecting fecal specimens and will collect data on major dietary restrictions (e.g., vegan, vegetarian, food allergies), medication use and major illnesses, knowledge of and past experience with fecal occult blood testing, colonoscopy and colon cancer, and the fecal collection devices. * Participants will be provided with a collection bag for the sample, 16 sample collection tubes, and a box with frozen gel packs. * On the morning of collection, participants will collect the fecal sample in the bag and use the collection tubes to obtain material from different parts of the stool. * The tubes will be sealed and placed in the box with the gel packs, and the participant will hand deliver the entire box to the clinical center. * Characteristics of the bacteria in the material will be measured by laboratories at the University of Maryland. * Statistical comparisons will determine how well the procedures worked.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • National Cancer Institute (nci), 9000 Rockville Pike

    Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
27 Apr 2010
Primary completion
—
Completion
14 Sept 2018
Last update posted
18 Sept 2018
Registered enrollment
98
Registry id
NCT01194687

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.