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Could a fiber supplement boost your vaccine?

NCT ID NCT04543877

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether adding a fiber supplement (inulin) to a low-fiber diet could increase helpful gut bacteria and improve the immune response to a typhoid vaccine. Sixty healthy adults with low fiber intake took either inulin or a placebo for five weeks, and all received the typhoid vaccine. Researchers measured changes in gut bacteria, inflammation, and vaccine antibody levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Inulin (a type of dietary fiber)
What this could lead to
If it works, this could point toward simple dietary changes to improve vaccine effectiveness and gut health.
What could go wrong
This is a very early, small study (60 people) looking at lab markers, not actual disease outcomes. Results may not apply to other vaccines or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

60 people

The number who actually took part.

Started

Sep 2022

Finished

Jun 2025

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 59 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Body Mass Index (BMI) 18.5 - 30.9 kg/m2 2. inadequate total dietary fiber intake defined as: * Females 18 - 30 years old, less than 28 g/day * Females 31 - 50 years old, less than 25 g/day * Females 51+ year old, less than 22 g/day * Males 18 - 30 years old, less than 34 g/day * Males 31 - 50 years old, less than 31 g/day * Males 51+ years old, less than 28 g/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 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • USDA, ARS, Western Human Nutrition Research Center

    Davis, California, 95616, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.