Summary

Eligibility
for people ages 18-50 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Davis, California
Dates
study started
estimated completion

Description

Summary

The purpose of this study is to determine if adding dietary fiber, such as inulin, to a diet that does not have enough fiber would raise the levels of potentially beneficial bacteria, such as Bifidobacterium, in the gut. There is evidence to suggest that these microbes can affect gut health and immune response, including to vaccines. The investigators will examine how inulin in the diet (compared to the maltodextrin control) (1) causes changes in the composition and function of the gut microbes, (2) reduces gut inflammation and gut leakiness caused by the vaccine, (3) increases immune response to vaccination, and (4) changes the expression of important adhesion molecules on the surface of white blood cells. Intestinal and whole-body responses will be measured in all participants.

Official Title

WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study

Details

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 3 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 counting T cells and immunoglobulin G (IgG) or immunoglobulin A (IgA)-secreting plasma cells specific for Ty21a. Gut permeability will be measured at baseline, and before and after the vaccine administration. Systemic inflammation and immune activation will be measured by analyzing blood for markers of inflammation.

Keywords

Inflammation, Vaccine, Intestinal Permeability, Typhoid Fever, Gastrointestinal Health, Vaccine Response, Ty21a Typhoid Vaccine, Microbiome, Bifidobacterium, Inulin, Maltodextrin, Ty21a Typhoid Fever Vaccine, Inulin and Ty21a Vaccine, Maltodextrin and Ty21a Vaccine

Eligibility

You can join if…

Open to people ages 18-50

  1. Body Mass Index (BMI) 18.5 - 30.9 kg/m2
  2. inadequate total dietary fiber intake defined as:
  3. Females 18 - 30 years old, less than 28 g/day
  4. Females 31 - 50 years old, less than 25 g/day
  5. Males 18 - 30 years old, less than 34 g/day
  6. Males 31 - 50 years old, less than 31 g/day

You CAN'T join if...

  1. blood pressure greater than or equal to 140/90 mmHg
  2. has HIV/AIDS or another disease that affects the immune system
  3. has any kind of cancer
  4. inability to lift 30 pounds with assistance (for transporting refrigerated stool containers)
  5. decline to take an HIV blood test
  6. pregnant or lactating women
  7. refusal to take a pregnancy test
  8. female subjects: refusal to use a method of birth control 1 week prior to the administration of the vaccine, 1 week during the vaccine, and 1 week after the vaccine
  9. allergy to vaccine components, i.e. thimerosal and enteric-coated capsules
  10. . allergy to oral typhoid vaccine
  11. . use of anti-inflammatory medications, i.e. nonsteroidal anti-inflammatory drugs (NSAID), aspirin, 3 or more times per month
  12. . use of sulfonamides or antibiotics 3 months prior to the receipt of Ty21a vaccine.
  13. . use of anti-hypertensive drugs, i.e. beta blockers, diuretics, calcium channel blockers
  14. . use of anti-malaria drugs, i.e. mefloquine, chloroquine, and proguanil
  15. . use of drugs that affects the immune system, i.e. immunosuppressants, immune-modifying drugs, corticosteroids, i.e. cortisone, prednisone, methylprednisolone, for 2 weeks or longer
  16. . use of biologics, i.e. Lantus, Remicade, Rituxan, Humira, Herceptin, Avastin, Lucentis, Enbrel for 2 weeks or longer
  17. . undergoing cancer treatment with radiation or drugs
  18. . greater than 10 years residence in a typhoid-endemic area
  19. . receipt of typhoid vaccine in the last 5 years
  20. . receipt of any vaccine two weeks prior to receipt of Ty21a vaccine
  21. . individuals at increased risk of developing complications from a live, bacterial vaccine
  22. . history of typhoid fever
  23. . history of primary immune deficiency or autoimmune disease
  24. . history of acute or chronic gastrointestinal (GI) disorder, i.e. Crohn's disease, irritable bowel syndrome, gastric ulcer
  25. . diarrheal illness (defined as passing 3 or more abnormally loose or watery stool in a 24 hour period) or persistent vomiting 2 weeks prior to the study
  26. . history of chronic illnesses, i.e. diabetes, cardiovascular disease, cancer, gastrointestinal malabsorption or inflammatory diseases, kidney disease, autoimmune disorders, HIV, liver disease, including hepatitis B and C
  27. . asthma if taking medication on a daily basis
  28. . recent surgery (within 3 months)
  29. . history of GI surgery
  30. . recent hospitalization (within 3 months)
  31. . fever (within 2 weeks)
  32. . unwillingness to discontinue probiotic, prebiotic, or other supplements (except Recommended Dietary Allowance-level vitamin and mineral supplements), fiber supplements, or food and beverage products containing inulin, chicory root fiber, or maltodextrin during the study
  33. . not having at least one arm vein suitable for blood drawing
  34. . unwilling or uncomfortable with blood draws and stool collections
  35. . regular blood or blood product donation and refusal to suspend donation
  36. . current participation in another research study
  37. . unable to fast for 12-16 hours
  38. . have fewer than 3 bowel movements per week
  39. . consuming one or more servings of added-inulin foods per day over the past month

Location

  • USDA, ARS, Western Human Nutrition Research Center accepting new patients
    Davis California 95616 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
USDA, Western Human Nutrition Research Center
Links
Sign up for this study
ID
NCT04543877
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated