The Influence of Histo-blood Group Antigen Polymorphism on the Composition of the Microbiota

Microbiota Analysis in Healthy Subjects Clinical Trial

Official title:

The Influence of Histo-blood Group Antigen Polymorphism on the Composition of the Microbiota

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02349932
• Other study ID #: IRB201400446-N
• Secondary ID: R01AI116892
• Status: Withdrawn
• Start date: July 2019
• Est. completion date: January 2023

Study information

• Verified date: August 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A person's blood type is defined by the types of sugars they express on their red blood cells, with antibodies being made to non-self sugars and excluding blood cells expressing these sugars (the basis of blood transfusion reactions). These same sugars can be expressed by commensal bacteria in our gut lumens. The investigators hypothesize that a person's antibodies to non-self sugars also attach to and exclude non-self sugar-expressing bacteria in our guts. Supporting our hypothesis, a person's blood type correlates with the overall composition of their gut flora. Because these sugars are also used by certain pathogens to initiate infection, this information could directly inform our understanding of host susceptibility to various infectious organisms.

Description:

A member of the study staff will collect a small volume of blood sample through a finger prick and 2-3 milliliters of saliva from you. Using these samples, we will determine your blood type (defined by your expression of specific sugars on your red blood cells) and your expression pattern of these sugars in body secretions (e.g., saliva). You will provide us with a fecal sample collected the day of your appointment. The fecal sample should be collected in a pre-provided collection container and should be collected within 12 hours of drop-off. Using your fecal sample, we will determine the types of bacteria present in your normal gut flora and whether they express the same sugars expressed on your blood cells. Tests will be done only for research purposes and will not be evaluated or used to diagnose or treat any of your medical problems. Sample collection may need to be repeated if required for your medical care in the future.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• healthy,

• adult

Exclusion Criteria:

• younger than 18,

• older than 60,

• pregnant

Related Conditions & MeSH terms

• Microbiota Analysis in Healthy Subjects

Intervention

Other:
• Healthy Adults
The following samples will be collected: fecal, blood, and saliva. The samples will be tested for HBGA-reactive antigens using an immunoaffinity assay.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood typing (Blood and saliva will be used to determine overall blood type)	Blood and saliva will be used to determine overall blood type.	1 day
Primary	Quantitative PCR (PCR will be used to enumerate commensal bacteria in fecal samples)	PCR will be used to enumerate commensal bacteria in fecal samples	1 day