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

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.

Study Overview

• Status: Withdrawn
• Conditions: Microbiota Analysis in Healthy Subjects
• Intervention / Treatment: Other: Healthy Adults

Detailed 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adults

Description

Inclusion Criteria:

• healthy,
• adult

Exclusion Criteria:

• younger than 18,
• older than 60,
• pregnant

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Adults; The following samples will be collected: fecal, blood, and saliva	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Stephanie M Karst, Ph.D., University of Florida

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2019
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: January 23, 2015
• First Submitted That Met QC Criteria: January 28, 2015
• First Posted (Estimate): January 29, 2015

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IRB201400446-N; R01AI116892 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No