Study Summary
This trial will test whether adding dietary fiber, in the form of inulin, to a diet lacking in fiber will raise levels of potentially beneficial gut bacteria, such as Bifidobacterium. The investigators will examine how inulin affects gut health and immune response, including to vaccines.
- Inflammation
- Typhoid
- Vaccines
- Leaky Gut Syndrome
Treatment Effectiveness
Study Objectives
6 Primary · 41 Secondary · Reporting Duration: 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
Trial Safety
Trial Design
2 Treatment Groups
Inulin and Ty21a Vaccine
1 of 2
Maltodextrin and Ty21a Vaccine
1 of 2
Experimental Treatment
Non-Treatment Group
60 Total Participants · 2 Treatment Groups
Primary Treatment: Inulin · Has Placebo Group · Phase < 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 50 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Meyer, D, and M Stasse-Wolthuis. 2009. “The Bifidogenic Effect of Inulin and Oligofructose and Its Consequences for Gut Health”. European Journal of Clinical Nutrition. Springer Science and Business Media LLC. doi:10.1038/ejcn.2009.64.
- Kolida, S, D Meyer, and G R Gibson. 2007. “A Double-blind Placebo-controlled Study to Establish the Bifidogenic Dose of Inulin in Healthy Humans”. European Journal of Clinical Nutrition. Springer Science and Business Media LLC. doi:10.1038/sj.ejcn.1602636.
- Menne, Evelyne, Nicolas Guggenbuhl, and Marcel Roberfroid. 2000. “Fn-type Chicory Inulin Hydrolysate Has a Prebiotic Effect in Humans”. The Journal of Nutrition. Oxford University Press (OUP). doi:10.1093/jn/130.5.1197.
- Micka, Antje, Anne Siepelmeyer, Anja Holz, Stephan Theis, and Christiane Schön. 2016. “Effect of Consumption of Chicory Inulin on Bowel Function in Healthy Subjects with Constipation: A Randomized, Double-blind, Placebo-controlled Trial”. International Journal of Food Sciences and Nutrition. Informa UK Limited. doi:10.1080/09637486.2016.1212819.
- Huda, M. Nazmul, Zachery Lewis, Karen M. Kalanetra, Mamunur Rashid, Shaikh M. Ahmad, Rubhana Raqib, Firdausi Qadri, Mark A. Underwood, David A. Mills, and Charles B. Stephensen. 2014. “Stool Microbiota and Vaccine Responses of Infants”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2013-3937.
- Zuckerman, Jane N, Christoph Hatz, and Anu Kantele. 2017. “Review of Current Typhoid Fever Vaccines, Cross-protection Against Paratyphoid Fever, and the European Guidelines”. Expert Review of Vaccines. Informa UK Limited. doi:10.1080/14760584.2017.1374861.
- Costabile, Adele, Sofia Kolida, Annett Klinder, Eva Gietl, Michael Bäuerlein, Claus Frohberg, Volker Landschütze, and Glenn R. Gibson. 2010. “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”. British Journal of Nutrition. Cambridge University Press (CUP). doi:10.1017/s0007114510001571.
- Petry, Nicolai, Ines Egli, Christophe Chassard, Christophe Lacroix, and Richard Hurrell. 2012. “Inulin Modifies the Bifidobacteria Population, Fecal Lactate Concentration, and Fecal Ph but Does Not Influence Iron Absorption in Women with Low Iron Status”. The American Journal of Clinical Nutrition. Oxford University Press (OUP). doi:10.3945/ajcn.112.035717.
- Holscher, Hannah D, Laura L Bauer, Vishnupriya Gourineni, Christine L Pelkman, George C Fahey Jr., and Kelly S Swanson. 2015. “Agave Inulin Supplementation Affects the Fecal Microbiota of Healthy Adults Participating in a Randomized, Double-blind, Placebo-controlled, Crossover Trial”. The Journal of Nutrition. Oxford University Press (OUP). doi:10.3945/jn.115.217331.
- Huda, M. Nazmul, Shaikh M. Ahmad, M. Jahangir Alam, Afsana Khanam, Karen M. Kalanetra, Diana H. Taft, Rubhana Raqib, Mark A. Underwood, David A. Mills, and Charles B. Stephensen. 2019. “bifidobacterium Abundance in Early Infancy and Vaccine Response at 2 Years of Age”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2018-1489.
- Salerno-Gonçalves, Rosângela, James E. Galen, Myron M. Levine, Alessio Fasano, and Marcelo B. Sztein. 2018. “Manipulation of Salmonella Typhi Gene Expression Impacts Innate Cell Responses in the Human Intestinal Mucosa”. Frontiers in Immunology. Frontiers Media SA. doi:10.3389/fimmu.2018.02543.
- Dewulf, Evelyne M, Patrice D Cani, Sandrine P Claus, Susana Fuentes, Philippe GB Puylaert, Audrey M Neyrinck, Laure B Bindels, et al.. 2012. “Insight into the Prebiotic Concept: Lessons from an Exploratory, Double Blind Intervention Study with Inulin-type Fructans in Obese Women”. Gut. BMJ. doi:10.1136/gutjnl-2012-303304.
- Fiorentino, Maria, Karen M. Lammers, Myron M. Levine, Marcelo B. Sztein, and Alessio Fasano. 2013. “In Vitro Intestinal Mucosal Epithelial Responses to Wild-type Salmonella Typhi and Attenuated Typhoid Vaccines”. Frontiers in Immunology. Frontiers Media SA. doi:10.3389/fimmu.2013.00017.
- Huda, M. Nazmul, Shaikh M. Ahmad, M. Jahangir Alam, Afsana Khanam, Karen M. Kalanetra, Diana H. Taft, Rubhana Raqib, Mark A. Underwood, David A. Mills, and Charles B. Stephensen. 2019. “bifidobacterium Abundance in Early Infancy and Vaccine Response at 2 Years of Age”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2018-1489.
- Holscher, Hannah D, Laura L Bauer, Vishnupriya Gourineni, Christine L Pelkman, George C Fahey Jr., and Kelly S Swanson. 2015. “Agave Inulin Supplementation Affects the Fecal Microbiota of Healthy Adults Participating in a Randomized, Double-blind, Placebo-controlled, Crossover Trial”. The Journal of Nutrition. Oxford University Press (OUP). doi:10.3945/jn.115.217331.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2022. "WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04543877.
Frequently Asked Questions
Is octogenarian age a permissible criterion for enrollment in this research study?
"In accordance with the requirements for enrollment, individuals must be between 18 and 50 years of age to qualify." - Anonymous Online Contributor
Are there any eligibility requirements for participation in this research trial?
"This research effort is seeking 60 individuals aged 18-50 with inflammation to participate. To be considered, applicants must satisfy the following parameters: Body Mass Index (BMI) of 18.5 - 30.9 kg/m2; females between ages 18 and 30 should consume no greater than 28 g/day while males in this age bracket cannot exceed 34 g/day; finally, for male and female participants over 31 years old, a maximum daily intake of 25g and 31g respectively is prescribed." - Anonymous Online Contributor
Are there any antecedent studies regarding the use of Inulin?
"Currently, there are 4 ongoing trials of Inulin in development, with none reaching Phase 3. Most trails for this medicine are located near Baltimore, Maryland but other centres across the USA have studies underway as well." - Anonymous Online Contributor
How many participants have been accepted into this research project?
"Affirmative. Clinicaltrial.gov data points to the fact that this trial is currently seeking participants, with an initial posting on September 27th 2022 and a final update being made November 29th of the same year. 60 people need to be enrolled at one location for successful completion." - Anonymous Online Contributor
Are there any available patient slots for this clinical research project?
"Data on clinicaltrials.gov indicates that this trial is presently recruiting potential participants, which first appeared on September 27th 2022 and was last revised November 29th 2022." - Anonymous Online Contributor
What results are researchers expecting from this clinical research?
"This clinical trial seeks to identify a change in antibody response to typhoid vaccination within Days 26, 37 and 39. Secondary objectives include assessing dietary fibre intake with a food frequency questionnaire, measuring acute phase reactants C-reactive protein (CRP) and serum amyloid A (SAA), as well as determining the relative abundance of colonic bacteria via polymerase chain reaction amplification and sequencing of 16s ribosomal RNA from stool samples collected 3 times per period." - Anonymous Online Contributor