InflammationEarly Phase 1NCT04543877

WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study

A Early Phase 1 study testing Inulin, Maltodextrin and Ty21a Typhoid Fever Vaccine in people with Inflammation and Vaccine, run by USDA, Western Human Nutrition Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: Inflammation, Vaccine, Intestinal Permeability
What is being tested?: Inulin, Maltodextrin and Ty21a Typhoid Fever Vaccine
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 27 Sep 2022to 11 Jun 2025
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Body Mass Index (BMI) 18.5 - 30.9 kg/m2
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

Who cannot join

blood pressure greater than or equal to 140/90 mmHg
has HIV/AIDS or another disease that affects the immune system
has any kind of cancer
inability to lift 30 pounds with assistance (for transporting refrigerated stool containers)
decline to take an HIV blood test
pregnant or lactating women

Show all 39Show fewer

refusal to take a pregnancy test
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
allergy to vaccine components, i.e. thimerosal and enteric-coated capsules
allergy to oral typhoid vaccine
use of anti-inflammatory medications, i.e. nonsteroidal anti-inflammatory drugs (NSAID), aspirin, 3 or more times per month
use of sulfonamides or antibiotics 3 months prior to the receipt of Ty21a vaccine.
use of anti-hypertensive drugs, i.e. beta blockers, diuretics, calcium channel blockers
use of anti-malaria drugs, i.e. mefloquine, chloroquine, and proguanil
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
use of biologics, i.e. Lantus, Remicade, Rituxan, Humira, Herceptin, Avastin, Lucentis, Enbrel for 2 weeks or longer
undergoing cancer treatment with radiation or drugs
greater than 10 years residence in a typhoid-endemic area
receipt of typhoid vaccine in the last 5 years
receipt of any vaccine two weeks prior to receipt of Ty21a vaccine
individuals at increased risk of developing complications from a live, bacterial vaccine
history of typhoid fever
history of primary immune deficiency or autoimmune disease
history of acute or chronic gastrointestinal (GI) disorder, i.e. Crohn's disease, irritable bowel syndrome, gastric ulcer
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
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
asthma if taking medication on a daily basis
recent surgery (within 3 months)
history of GI surgery
recent hospitalization (within 3 months)
fever (within 2 weeks)
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
not having at least one arm vein suitable for blood drawing
unwilling or uncomfortable with blood draws and stool collections
regular blood or blood product donation and refusal to suspend donation
current participation in another research study
unable to fast for 12-16 hours
have fewer than 3 bowel movements per week
consuming one or more servings of added-inulin foods per day over the past month

Trial locations and contacts

1 site in 1 country.

United States1 site

USDA, ARS, Western Human Nutrition Research Center
Davis, California, 95616

Other trials in United States

About this study

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.

Read the 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 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.

Conditions: Inflammation, Vaccine, Intestinal Permeability, Typhoid Fever
Being tested: Inulin, Maltodextrin, Ty21a Typhoid Fever Vaccine
Keywords: Gastrointestinal Health, Intestinal Permeability, Vaccine Response, Inflammation, Ty21a Typhoid Vaccine, Typhoid Fever, Microbiome, Bifidobacterium
Medical subject headings: Inflammation, Typhoid Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InulinDietary supplement
Also called Orafti GR
Consume 12 grams/day of inulin for 5 weeks (Day 9 - 43).
MaltodextrinDietary supplement
Also called Maltrin M100
Consume 12 grams/day of maltodextrin for 5 weeks (Day 9 - 43).
Ty21a Typhoid Fever VaccineBiological
Also called Vivotif
All participants will receive the vaccine. One capsule is swallowed on alternate days, e.g. days 30, 32, 34, and 36 for a total of 4 capsules.

Study groups in NCT04543877
Study group	Role	What they receive
Inulin and Ty21a Vaccine	Experimental	Participants will consume 12 grams/day of inulin for 3 weeks before the administration of the Ty21a vaccine, 1 week during the vaccine, and 1 week after the vaccine for a total of 5 weeks. Receives: Dietary Supplement: Inulin; Biological: Ty21a Typhoid Fever Vaccine
Maltodextrin and Ty21a Vaccine	Placebo comparator	Participants will consume 12 grams/day of maltodextrin (control) for 3 weeks before the administration of the Ty21a vaccine, 1 week during the vaccine, and 1 week after the vaccine for a total of 5 weeks. Receives: Dietary Supplement: Maltodextrin; Biological: Ty21a Typhoid Fever Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in vaccine-specific antibody-secreting cell response to oral Ty21a typhoid vaccination using the standard 4-dose regimen
Measurement of baseline level (Day 26; before first vaccine dose) and post-vaccine, antibody response, Immunoglobulin G (IgG), Immunoglobulin M (IgM) and IgA, 7 and 9 days after the first vaccine dose using the antibody-in-lymphocyte-supernatant (ALS) assay to identify antibody-secreting cells in blood. Two antigens will be used: Ty21a outer membrane protein and lipopolysaccharide from Salmonella Typhi.
Measured: Day 26, 37, and 39

Secondary outcomes (17)

Change in vaccine-specific serum antibody response to typhoid vaccination
Measurement of baseline level (Day 26; before first vaccine dose) and post-vaccine (28 d after first vaccine dose) antibody levels (IgG, IgM, IgA)
Measured: Day 26 and 58
Change in vaccine-specific fecal IgA antibody levels from typhoid vaccination
Measurement of baseline level (Day 26; before first vaccination dose) and change in fecal antibody levels
Measured: Day 26, 39, and 58
Change in plasma cytokines as markers of systemic inflammation
Measurement of plasma cytokines, such as interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-alpha), and IL-1beta
Measured: Day 8, 26, 37, 39, and 58
Change in plasma acute phase proteins and adhesion molecules
Measurement of acute phase reactants, such as C-reactive protein (CRP) and serum amyloid-A (SAA), and intercellular adhesion molecules, such as intercellular adhesion molecule-1 (ICAM-1) and vascular endothelial cell adhesion molecule-1 (VCAM-1)
Measured: Day 8, 26, 37, 39, and 58
Change in a plasma marker of lipopolysaccharide (LPS) exposure
Measurement of plasma LPS-binding protein using an ELISA.
Measured: Day 8, 26, 37, 39, and 58
Change in blood monocyte subsets
Monocyte subsets will be analyzed using flow cytometry.
Measured: Day 8, 26, 37, 39, and 58
Change in plasma short chain fatty acids (SCFA)
Plasma SCFA will be measured using liquid chromatography-mass spectrometry (LC-MS).
Measured: Day 8, 26, 37, 39, and 58
Change in urinary lactulose and D-mannitol
Measurement of lactulose to mannitol ratio, an indicator of intestinal permeability, in urine
Measured: Day 8, 26, and 37
Change in fecal microbiome
Measurement of relative abundance of colonic bacteria using DNA isolated from stool.
Measured: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in fecal mRNA
Total RNA, and specifically, messenger ribonucleic acid (mRNA), will be analyzed from preserved stools.
Measured: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in stool consistency and frequency
Measurement of stool consistency using the Bristol stool scale, a medical tool used to classify stool forms into 7 categories, and frequency via self-report in diaries.
Measured: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in GI symptoms
Measurement of GI symptoms using a 10-symptom health questionnaire with degree of discomfort ranked in one of four categories (0 absent, 1 mild, 2 moderate, or 3 severe; PMID: 9301412)
Measured: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in fecal pH
Measurement of fecal pH using a standard pH meter.
Measured: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in fecal calprotectin
Measurement of calprotectin will be done by ELISA
Measured: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in fecal SCFA
Measurement of SCFA will be done by gas chromatography-mass spectrometry (GC-MS.)
Measured: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in fecal metabolites
Measurement of bile acids and other metabolites will be measured
Measured: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in fecal secretory total immunoglobulin A (sIgA)
Measurement of total fecal sIgA using ELISA.
Measured: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 202211 Jun 2025

First posted10 Sep 2020
Study start27 Sep 2022
Primary completion11 Jun 2025
Study completion11 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for InflammationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04543877
Sponsor's protocol ID: FL113
Status last verified: Dec 2025
First submitted: 24 Aug 2020
Last updated: 17 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Meyer D, Stasse-Wolthuis M. The bifidogenic effect of inulin and oligofructose and its consequences for gut health. Eur J Clin Nutr. 2009 Nov;63(11):1277-89. doi: 10.1038/ejcn.2009.64. Epub 2009 Aug 19.
PubMed 19690573
Costabile A, Kolida S, Klinder A, Gietl E, Bauerlein M, Frohberg C, Landschutze V, Gibson GR. A double-blind, placebo-controlled, cross-over study to establish the bifidogenic effect of a very-long-chain inulin extracted from globe artichoke (Cynara scolymus) in healthy human subjects. Br J Nutr. 2010 Oct;104(7):1007-17. doi: 10.1017/S0007114510001571. Epub 2010 Jul 1.
PubMed 20591206
Dewulf EM, Cani PD, Claus SP, Fuentes S, Puylaert PG, Neyrinck AM, Bindels LB, de Vos WM, Gibson GR, Thissen JP, Delzenne NM. Insight into the prebiotic concept: lessons from an exploratory, double blind intervention study with inulin-type fructans in obese women. Gut. 2013 Aug;62(8):1112-21. doi: 10.1136/gutjnl-2012-303304. Epub 2012 Nov 7.
PubMed 23135760
Holscher HD, Bauer LL, Gourineni V, Pelkman CL, Fahey GC Jr, Swanson KS. Agave Inulin Supplementation Affects the Fecal Microbiota of Healthy Adults Participating in a Randomized, Double-Blind, Placebo-Controlled, Crossover Trial. J Nutr. 2015 Sep;145(9):2025-32. doi: 10.3945/jn.115.217331. Epub 2015 Jul 22.
PubMed 26203099
Kolida S, Meyer D, Gibson GR. A double-blind placebo-controlled study to establish the bifidogenic dose of inulin in healthy humans. Eur J Clin Nutr. 2007 Oct;61(10):1189-95. doi: 10.1038/sj.ejcn.1602636. Epub 2007 Jan 31.
PubMed 17268410
Menne E, Guggenbuhl N, Roberfroid M. Fn-type chicory inulin hydrolysate has a prebiotic effect in humans. J Nutr. 2000 May;130(5):1197-9. doi: 10.1093/jn/130.5.1197.
PubMed 10801918
Micka A, Siepelmeyer A, Holz A, Theis S, Schon C. Effect of consumption of chicory inulin on bowel function in healthy subjects with constipation: a randomized, double-blind, placebo-controlled trial. Int J Food Sci Nutr. 2017 Feb;68(1):82-89. doi: 10.1080/09637486.2016.1212819. Epub 2016 Aug 5.
PubMed 27492975
Petry N, Egli I, Chassard C, Lacroix C, Hurrell R. Inulin modifies the bifidobacteria population, fecal lactate concentration, and fecal pH but does not influence iron absorption in women with low iron status. Am J Clin Nutr. 2012 Aug;96(2):325-31. doi: 10.3945/ajcn.112.035717. Epub 2012 Jun 27.
PubMed 22743314
Huda MN, Lewis Z, Kalanetra KM, Rashid M, Ahmad SM, Raqib R, Qadri F, Underwood MA, Mills DA, Stephensen CB. Stool microbiota and vaccine responses of infants. Pediatrics. 2014 Aug;134(2):e362-72. doi: 10.1542/peds.2013-3937. Epub 2014 Jul 7.
PubMed 25002669
Huda MN, Ahmad SM, Alam MJ, Khanam A, Kalanetra KM, Taft DH, Raqib R, Underwood MA, Mills DA, Stephensen CB. Bifidobacterium Abundance in Early Infancy and Vaccine Response at 2 Years of Age. Pediatrics. 2019 Feb;143(2):e20181489. doi: 10.1542/peds.2018-1489.
PubMed 30674610
Zuckerman JN, Hatz C, Kantele A. Review of current typhoid fever vaccines, cross-protection against paratyphoid fever, and the European guidelines. Expert Rev Vaccines. 2017 Oct;16(10):1029-1043. doi: 10.1080/14760584.2017.1374861.
PubMed 28856924
Fiorentino M, Lammers KM, Levine MM, Sztein MB, Fasano A. In vitro Intestinal Mucosal Epithelial Responses to Wild-Type Salmonella Typhi and Attenuated Typhoid Vaccines. Front Immunol. 2013 Feb 12;4:17. doi: 10.3389/fimmu.2013.00017. eCollection 2013.
PubMed 23408152
Salerno-Goncalves R, Galen JE, Levine MM, Fasano A, Sztein MB. Manipulation of Salmonella Typhi Gene Expression Impacts Innate Cell Responses in the Human Intestinal Mucosa. Front Immunol. 2018 Nov 1;9:2543. doi: 10.3389/fimmu.2018.02543. eCollection 2018.
PubMed 30443257

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study
ClinicalTrials.gov ID: NCT04543877
Acronym / sponsor ID: FL113
Conditions: Inflammation, Vaccine, Intestinal Permeability, Typhoid Fever
Keywords: Gastrointestinal Health, Intestinal Permeability, Vaccine Response, Inflammation, Ty21a Typhoid Vaccine, Typhoid Fever, Microbiome, Bifidobacterium
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: USDA, Western Human Nutrition Research CenterUS federal agency
Collaborators: University of Minnesota
Study start: 27 Sep 2022 (actual)
Primary completion: 11 Jun 2025 (actual)
Study completion: 11 Jun 2025 (actual)
First posted: 10 Sep 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Inulin and Ty21a Vaccine	Experimental	Dietary Supplement: Inulin, Biological: Ty21a Typhoid Fever VaccineParticipants will consume 12 grams/day of inulin for 3 weeks before the administration of the Ty21a vaccine, 1 week during the vaccine, and 1 week after the vaccine for a total of 5 weeks.
Maltodextrin and Ty21a Vaccine	Placebo comparator	Dietary Supplement: Maltodextrin, Biological: Ty21a Typhoid Fever VaccineParticipants will consume 12 grams/day of maltodextrin (control) for 3 weeks before the administration of the Ty21a vaccine, 1 week during the vaccine, and 1 week after the vaccine for a total of 5 weeks.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Body Mass Index (BMI) 18.5 - 30.9 kg/m2
inadequate total dietary fiber intake defined as:

Key exclusion criteria (39 listed)

blood pressure greater than or equal to 140/90 mmHg
has HIV/AIDS or another disease that affects the immune system
has any kind of cancer
inability to lift 30 pounds with assistance (for transporting refrigerated stool containers)
decline to take an HIV blood test

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
InulinAlso: Orafti GRConsume 12 grams/day of inulin for 5 weeks (Day 9 - 43).	Dietary supplement	Inulin and Ty21a Vaccine
MaltodextrinAlso: Maltrin M100Consume 12 grams/day of maltodextrin for 5 weeks (Day 9 - 43).	Dietary supplement	Maltodextrin and Ty21a Vaccine
Ty21a Typhoid Fever VaccineAlso: VivotifAll participants will receive the vaccine. One capsule is swallowed on alternate days, e.g. days 30, 32, 34, and 36 for a total of 4 capsules.	Biological	Inulin and Ty21a Vaccine, Maltodextrin and Ty21a Vaccine

Primary outcome

Change in vaccine-specific antibody-secreting cell response to oral Ty21a typhoid vaccination using the standard 4-dose regimen
Time frame: Day 26, 37, and 39
Measurement of baseline level (Day 26; before first vaccine dose) and post-vaccine, antibody response, Immunoglobulin G (IgG), Immunoglobulin M (IgM) and IgA, 7 and 9 days after the first vaccine dose using the antibody-in-lymphocyte-supernatant (ALS) assay to identify antibody-secreting cells in blood. Two antigens will be used: Ty21a outer membrane protein and lipopolysaccharide from Salmonella Typhi.

17 secondary outcomes

Change in vaccine-specific serum antibody response to typhoid vaccination
Time frame: Day 26 and 58
Change in vaccine-specific fecal IgA antibody levels from typhoid vaccination
Time frame: Day 26, 39, and 58
Change in plasma cytokines as markers of systemic inflammation
Time frame: Day 8, 26, 37, 39, and 58
Change in plasma acute phase proteins and adhesion molecules
Time frame: Day 8, 26, 37, 39, and 58
Change in a plasma marker of lipopolysaccharide (LPS) exposure
Time frame: Day 8, 26, 37, 39, and 58
Change in blood monocyte subsets
Time frame: Day 8, 26, 37, 39, and 58
Change in plasma short chain fatty acids (SCFA)
Time frame: Day 8, 26, 37, 39, and 58
Change in urinary lactulose and D-mannitol
Time frame: Day 8, 26, and 37
Change in fecal microbiome
Time frame: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in fecal mRNA
Time frame: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in stool consistency and frequency
Time frame: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in GI symptoms
Time frame: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in fecal pH
Time frame: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in fecal calprotectin
Time frame: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in fecal SCFA
Time frame: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in fecal metabolites
Time frame: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65
Change in fecal secretory total immunoglobulin A (sIgA)
Time frame: Period 1: Days 1-7; Period 2: Days 16-25; Period 3: Days 26-36; Period 4: Days 37-43; Period 5: Days 58-65

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
Background: PubMed 19690573Meyer D, Stasse-Wolthuis M. The bifidogenic effect of inulin and oligofructose and its consequences for gut health. Eur J Clin Nutr. 2009 Nov;63(11):1277-89. doi: 10.1038/ejcn.2009.64. Epub 2009 Aug 19.
Background: PubMed 20591206Costabile A, Kolida S, Klinder A, Gietl E, Bauerlein M, Frohberg C, Landschutze V, Gibson GR. A double-blind, placebo-controlled, cross-over study to establish the bifidogenic effect of a very-long-chain inulin extracted from globe artichoke (Cynara scolymus) in healthy human subjects. Br J Nutr. 2010 Oct;104(7):1007-17. doi: 10.1017/S0007114510001571. Epub 2010 Jul 1.
Background: PubMed 23135760Dewulf EM, Cani PD, Claus SP, Fuentes S, Puylaert PG, Neyrinck AM, Bindels LB, de Vos WM, Gibson GR, Thissen JP, Delzenne NM. Insight into the prebiotic concept: lessons from an exploratory, double blind intervention study with inulin-type fructans in obese women. Gut. 2013 Aug;62(8):1112-21. doi: 10.1136/gutjnl-2012-303304. Epub 2012 Nov 7.
Background: PubMed 26203099Holscher HD, Bauer LL, Gourineni V, Pelkman CL, Fahey GC Jr, Swanson KS. Agave Inulin Supplementation Affects the Fecal Microbiota of Healthy Adults Participating in a Randomized, Double-Blind, Placebo-Controlled, Crossover Trial. J Nutr. 2015 Sep;145(9):2025-32. doi: 10.3945/jn.115.217331. Epub 2015 Jul 22.
Background: PubMed 17268410Kolida S, Meyer D, Gibson GR. A double-blind placebo-controlled study to establish the bifidogenic dose of inulin in healthy humans. Eur J Clin Nutr. 2007 Oct;61(10):1189-95. doi: 10.1038/sj.ejcn.1602636. Epub 2007 Jan 31.
Background: PubMed 10801918Menne E, Guggenbuhl N, Roberfroid M. Fn-type chicory inulin hydrolysate has a prebiotic effect in humans. J Nutr. 2000 May;130(5):1197-9. doi: 10.1093/jn/130.5.1197.
Background: PubMed 27492975Micka A, Siepelmeyer A, Holz A, Theis S, Schon C. Effect of consumption of chicory inulin on bowel function in healthy subjects with constipation: a randomized, double-blind, placebo-controlled trial. Int J Food Sci Nutr. 2017 Feb;68(1):82-89. doi: 10.1080/09637486.2016.1212819. Epub 2016 Aug 5.
Background: PubMed 22743314Petry N, Egli I, Chassard C, Lacroix C, Hurrell R. Inulin modifies the bifidobacteria population, fecal lactate concentration, and fecal pH but does not influence iron absorption in women with low iron status. Am J Clin Nutr. 2012 Aug;96(2):325-31. doi: 10.3945/ajcn.112.035717. Epub 2012 Jun 27.
Background: PubMed 25002669Huda MN, Lewis Z, Kalanetra KM, Rashid M, Ahmad SM, Raqib R, Qadri F, Underwood MA, Mills DA, Stephensen CB. Stool microbiota and vaccine responses of infants. Pediatrics. 2014 Aug;134(2):e362-72. doi: 10.1542/peds.2013-3937. Epub 2014 Jul 7.
Background: PubMed 30674610Huda MN, Ahmad SM, Alam MJ, Khanam A, Kalanetra KM, Taft DH, Raqib R, Underwood MA, Mills DA, Stephensen CB. Bifidobacterium Abundance in Early Infancy and Vaccine Response at 2 Years of Age. Pediatrics. 2019 Feb;143(2):e20181489. doi: 10.1542/peds.2018-1489.
Background: PubMed 28856924Zuckerman JN, Hatz C, Kantele A. Review of current typhoid fever vaccines, cross-protection against paratyphoid fever, and the European guidelines. Expert Rev Vaccines. 2017 Oct;16(10):1029-1043. doi: 10.1080/14760584.2017.1374861.
Background: PubMed 23408152Fiorentino M, Lammers KM, Levine MM, Sztein MB, Fasano A. In vitro Intestinal Mucosal Epithelial Responses to Wild-Type Salmonella Typhi and Attenuated Typhoid Vaccines. Front Immunol. 2013 Feb 12;4:17. doi: 10.3389/fimmu.2013.00017. eCollection 2013.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Danielle Lemay, PhD principal investigator

USDA, ARS, Western Human Nutrition Research Center

Ryan Snodgrass, PhD principal investigator

USDA, ARS, Western Human Nutrition Research Center

Mary Kable, PhD principal investigator

USDA, ARS, Western Human Nutrition Research Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in vaccine-specific antibody-secreting cell response to oral Ty21a typhoid vaccination using the standard 4-dose regimen (time frame: Day 26, 37, and 39). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04543877, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.