Normal PhysiologyNCT01194687
Reproducibility of a Fecal Occult Blood Test Device for Gut Microbiota Analyses
An observational study of Normal Physiology, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Normal Physiology
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2010to 14 Sep 2018
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NIH employee, minimum age 18 years.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
Commensal bacteria and other microbial organisms (the microbiota), particularly in the intestines, are centrally related to nutrition, metabolism, immunity, inflammation, and endocrine balance. As an initial step toward possible establishment of a biobank of feces that could be used for prospective studies of the relationship of microbiota to cancer and other conditions, we propose a study to evaluate whether fecal microbiota, as well as microbial enzyme expression and function, are reproducibly represented in feces that has been collected with a device that is widely used for fecal occult blood testing (FOBT-CHEK oc). To do so, this study will recruit a convenience sample of 50 volunteers from DCEG and others at NIH. From a single stool, each participant will provide 16 aliquots of feces, half collected with FOBT-CHEK oc and the rest with a larger Sarstedt device. A urine sample and a brief self-administered questionnaire on antibiotics and other medications, serious chronic diseases, and major cancer risk factors will also be obtained. The aliquots will be used for microbiome pyrosequencing, beta-glucuronidase and beta-glucosidase expression and enzymatic activity. Variance within and between collection devices, as well as between individuals, will be quantified. This study will provide insight and quantitative estimates that will be required for formal studies of the relationship of the fecal microbiome to cancer. Under an amendment, to examine the ability of selected antibiotics to stabilize fecal microbial populations when they have been stored at 3 or 7 days prior to freezing, 10 of the same volunteer participants will be asked to provide aliquots of a second stool specimen. Differences between immediate and delayed freezing with or without the antibiotics will be tested by analysis of variance. Under an amendment, up to 100 participants will be enrolled to examine reproducibility of the microbiota with a used commercial colorectal cancer screening device and the stability of the microbiota within individuals over four years, participants will be asked to collect specimens during 2014, exactly as was done during 2010. Assays and anlyses will be analogous to those performed previously.
- Conditions
- Normal Physiology
- Keywords
- Estrogens, Fecal Microbiome, Fecal Occult Blood
What is being measured
The primary outcome is the main question the study is designed to answer.
Micriobiome Reproducibility
Measured: Cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study start27 Apr 2010
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Normal PhysiologyStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rashmi Sinha, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194687
- Sponsor's protocol ID
- 999910107
- Other IDs
- 10-C-N107
- Status last verified
- 14 Sep 2018
- First submitted
- 2 Sep 2010
- Last updated
- 18 Sep 2018
- Results posted
- No
Publications
Flores R, Shi J, Gail MH, Gajer P, Ravel J, Goedert JJ. Assessment of the human faecal microbiota: II. Reproducibility and associations of 16S rRNA pyrosequences. Eur J Clin Invest. 2012 Aug;42(8):855-63. doi: 10.1111/j.1365-2362.2012.02659.x. Epub 2012 Mar 3.
PubMed 22385292Flores R, Shi J, Gail MH, Ravel J, Goedert JJ. Assessment of the human faecal microbiota: I. Measurement and reproducibility of selected enzymatic activities. Eur J Clin Invest. 2012 Aug;42(8):848-54. doi: 10.1111/j.1365-2362.2012.02660.x. Epub 2012 Mar 13.
PubMed 22409163Flores R, Shi J, Fuhrman B, Xu X, Veenstra TD, Gail MH, Gajer P, Ravel J, Goedert JJ. Fecal microbial determinants of fecal and systemic estrogens and estrogen metabolites: a cross-sectional study. J Transl Med. 2012 Dec 21;10:253. doi: 10.1186/1479-5876-10-253.
PubMed 23259758
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of a Fecal Occult Blood Test Device for Gut Microbiota Analyses
- ClinicalTrials.gov ID
- NCT01194687
- Acronym / sponsor ID
- 999910107
- Conditions
- Normal Physiology
- Keywords
- Estrogens, Fecal Microbiome, Fecal Occult Blood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 27 Apr 2010
- Study completion
- 14 Sep 2018
- First posted
- 3 Sep 2010 (estimated)
- 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.
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.
Detailed description
Commensal bacteria and other microbial organisms (the microbiota), particularly in the intestines, are centrally related to nutrition, metabolism, immunity, inflammation, and endocrine balance. As an initial step toward possible establishment of a biobank of feces that could be used for prospective studies of the relationship of microbiota to cancer and other conditions, we propose a study to evaluate whether fecal microbiota, as well as microbial enzyme expression and function, are reproducibly represented in feces that has been collected with a device that is widely used for fecal occult blood testing (FOBT-CHEK oc). To do so, this study will recruit a convenience sample of 50 volunteers from DCEG and others at NIH. From a single stool, each participant will provide 16 aliquots of feces, half collected with FOBT-CHEK oc and the rest with a larger Sarstedt device. A urine sample and a brief self-administered questionnaire on antibiotics and other medications, serious chronic diseases, and major cancer risk factors will also be obtained. The aliquots will be used for microbiome pyrosequencing, beta-glucuronidase and beta-glucosidase expression and enzymatic activity. Variance within and between collection devices, as well as between individuals, will be quantified. This study will provide insight and quantitative estimates that will be required for formal studies of the relationship of the fecal microbiome to cancer. Under an amendment, to examine the ability of selected antibiotics to stabilize fecal microbial populations when they have been stored at 3 or 7 days prior to freezing, 10 of the same volunteer participants will be asked to provide aliquots of a second stool specimen. Differences between immediate and delayed freezing with or without the antibiotics will be tested by analysis of variance. Under an amendment, up to 100 participants will be enrolled to examine reproducibility of the microbiota with a used commercial colorectal cancer screening device and the stability of the microbiota within individuals over four years, participants will be asked to collect specimens during 2014, exactly as was done during 2010. Assays and anlyses will be analogous to those performed previously.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- NIH employee, minimum age 18 years.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Micriobiome Reproducibility
Time frame: Cross-sectional
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 18 Sep 2018.
- Background: PubMed 22385292Flores R, Shi J, Gail MH, Gajer P, Ravel J, Goedert JJ. Assessment of the human faecal microbiota: II. Reproducibility and associations of 16S rRNA pyrosequences. Eur J Clin Invest. 2012 Aug;42(8):855-63. doi: 10.1111/j.1365-2362.2012.02659.x. Epub 2012 Mar 3.
- Background: PubMed 22409163Flores R, Shi J, Gail MH, Ravel J, Goedert JJ. Assessment of the human faecal microbiota: I. Measurement and reproducibility of selected enzymatic activities. Eur J Clin Invest. 2012 Aug;42(8):848-54. doi: 10.1111/j.1365-2362.2012.02660.x. Epub 2012 Mar 13.
- Background: PubMed 23259758Flores R, Shi J, Fuhrman B, Xu X, Veenstra TD, Gail MH, Gajer P, Ravel J, Goedert JJ. Fecal microbial determinants of fecal and systemic estrogens and estrogen metabolites: a cross-sectional study. J Transl Med. 2012 Dec 21;10:253. doi: 10.1186/1479-5876-10-253.
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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.
Rashmi Sinha, Ph.D. principal investigator
National Cancer Institute (NCI)
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 Normal Physiology, run by National Cancer Institute (NCI) at 1 site in United States.
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 1 inclusion and 0 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 18 Sep 2018. 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 United States. 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?
Micriobiome Reproducibility (time frame: Cross-sectional). 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 NCT01194687, which also lists 3 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 18 Sep 2018.