Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Inflammation
  • Intestinal Permeability
  • Typhoid Fever
  • Vaccine
Type
Interventional
Phase
Early Phase 1
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 49 years
Gender
Both males and females

Description

Inulin, a dietary fiber supplement, is known to increase gut levels of potentially beneficial bacteria, including Bifidobacterium that are indigenous to gut microbiomes. Our underlying hypothesis is that the commensal microbiome, including Bifidobacterium, in the proximal colon or distal ileum affec...

Inulin, a dietary fiber supplement, is known to increase gut levels of potentially beneficial bacteria, including Bifidobacterium that are indigenous to gut microbiomes. Our underlying hypothesis is that the commensal microbiome, including Bifidobacterium, in the proximal colon or distal ileum affects the environment of draining lymph nodes and can thus modulate immune responses, including to vaccines. In the current study, participants will consume 12 grams/day inulin or maltodextrin (control) for 4 weeks before the administration of the Ty21a typhoid fever vaccine, 1 week during the vaccine, and 1 week after the vaccine. Vaccine response will be measured by quantitating T cells and IgG- or IgA-secreting plasma cells specific for Ty21a. Gut permeability will be measured before and after the inulin intervention, before and after the vaccine administration, and at the end of the study. Systemic inflammation and immune activation will be measured by analyzing blood for markers of inflammation.

Tracking Information

NCT #
NCT04543877
Collaborators
University of Minnesota
Investigators
Principal Investigator: Danielle Lemay, PhD USDA, ARS, Western Human Nutrition Research Center Principal Investigator: Charles Stephensen, PhD USDA, ARS, Western Human Nutrition Research Center Principal Investigator: Mary Kable, PhD USDA, ARS, Western Human Nutrition Research Center