WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study

Learn more about:
Related Clinical Trial
Transcriptomic Responses for the Identification of Pathogens Evaluation of Typhoid Conjugate Vaccine Effectiveness in Ghana Non-inferiority and Safety Study of EuTCV Compared to Typbar-TCV in Healthy 6 Months-45 Years Aged Participants Commercial Typhoid Tests Validation Trial Commercial Typhoid Tests Validation WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial) Phase 4 Study To Assess The Safety Of Vivotif At Different Release Titers Among Travelers Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old) Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old) Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort Safety and Immunogenicity of Typhax, a Typhoid Vaccine Safety and Tolerability of Typhoid Conjugate Vaccine (EuTCV) in Healthy Adults Immune Equivalence Between Multi-dose and Single Dose Formulation of Vi-DT and Their Overall Safety (Phase III) Investigating Enteric Fever – Salmonella Typhi and Paratyphi Challenge Study Induction of Gut Permeability by an Oral Vaccine Studies of Immune Responses to Orally Administered Vaccines in Developing Country Long Term Protection by and Persistence of Vi Antibodies Induced by Vi-rEPA Conjugate Vaccines in Vietnamese Children Injected at 2-5 Years or at 5-8 Years of Age Salmonella Typhi Vi O-Acetyl Pectin-rEPA Conjugate Vaccine Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants Typhoid Fever: Combined vs. Single Antibiotic Therapy Vaccines Against Salmonella Typhi Immune Non-inferiority and Safety of a Vi-DT Typhoid Conjugate Vaccine Dose Ranging Study to Determine the Safety, Reactogenicity and Immunogenicity of Typhoid Fever Vaccine (Ty800) in Healthy Adult Subjects Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults CVD 909 Vi Prime Boost Study Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine Typhoid Conjugate Vaccine Introduction in Navi Mumbai, India Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects Typhoid Conjugate Vaccine Trial Among Children Younger Than 2 Years in Ouagadougou, Burkina Faso Understanding Typhoid Disease After Vaccination Typhoid Vi Vaccine Effectiveness in Hechi, Guangxi, China Introduction of the Vi Polysaccharide Typhoid Vaccine in Hue City, Central Vietnam Comparison of Two Drugs Regimen in Treatment of Complicated Typhoid Fever in Children Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine Combined Vi Vaccination and Health Education Program on the Burden of Typhoid in Childhood Global Genomic and Proteomic Profiling of African Children With Typhoid Fever

Brief Title

WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study

Official Title

WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study

Brief 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, and (3) increases immune response to vaccination. Intestinal and
      whole-body responses will be measured in all participants.
    

Detailed 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 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.
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Change in antibody response to typhoid vaccination

Secondary Outcome

 Change in fecal microbiome

Condition

Inflammation

Intervention

Inulin

Study Arms / Comparison Groups

 Inulin and Ty21a Vaccine
Description:  Participants will consume 12 grams/day of inulin for 4 weeks before the administration of the Ty21a vaccine, 1 week during the vaccine, and 1 week after the vaccine for a total of 6 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

60

Start Date

October 30, 2021

Completion Date

March 30, 2023

Primary Completion Date

March 30, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Body Mass Index (BMI) 18.5 - 39.9 kg/m2

          2. inadequate total dietary fiber intake (<14 g/1000 kcal/day)

        Exclusion Criteria:

          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 1 week 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 consumption of artificial sweeteners in foods or drinks,
             i.e. sport drinks, coconut water, "diet" drinks and foods (possibly containing
             sucralose)

         33. 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

         34. not having at least one arm vein suitable for blood drawing

         35. unwilling or uncomfortable with blood draws and 24-hour urine and stool collection

         36. regular blood or blood product donation and refusal to suspend donation

         37. current participation in another research study

         38. unable to fast for 12-16 hours
      

Gender

All

Ages

18 Years - 49 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Danielle Lemay, PhD, 530-752-4184, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04543877

Organization ID

FL113


Responsible Party

Sponsor

Study Sponsor

USDA, Western Human Nutrition Research Center

Collaborators

 University of Minnesota

Study Sponsor

Danielle Lemay, PhD, Principal Investigator, USDA, ARS, Western Human Nutrition Research Center


Verification Date

February 2021