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Dietary Fiber (Inulin) for Gut Health and Immune Response
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am a male between 18 and 30 years old.I am taking medication for high blood pressure.I have not had severe diarrhea or constant vomiting in the last 2 weeks.I have not had a fever in the last 2 weeks.You have a history of a weak immune system or an autoimmune disease.I haven't received any vaccines in the two weeks before getting the Ty21a vaccine.You are allergic to the oral typhoid vaccine.I have a chronic illness such as diabetes, heart disease, or liver disease.You have a higher chance of experiencing problems if you receive a live, bacterial vaccine.I have a history of stomach or bowel problems like Crohn's, IBS, or ulcers.I have fewer than 3 bowel movements weekly.I am a woman aged 31-50 and drink less than 25g of alcohol daily.I have not used immune system affecting drugs like cortisone for 2 weeks or more.You cannot continue taking probiotics, prebiotics, or certain supplements and foods during the study.I have asthma and take medication for it every day.I am currently taking or have recently taken anti-malaria medication.I do not have a vein in my arm suitable for drawing blood.I have had surgery on my digestive system.I agree to use birth control before, during, and after the vaccine period.I was hospitalized within the last 3 months.I have received the typhoid vaccine in the last 5 years.I have lived in a typhoid-endemic area for over 10 years.I am currently receiving cancer treatment with radiation or medication.I am a man aged 31-50 and consume less than 31 grams of alcohol daily.I have had typhoid fever in the past.Your body weight is within a healthy range based on your height.I haven't taken sulfonamides or antibiotics in the last 3 months.I have been using a biologic medication for at least 2 weeks.I have been diagnosed with cancer.I have not had surgery in the last 3 months.I cannot lift 30 pounds even with help.I have HIV/AIDS or another immune system condition.I am a woman aged 18-30 and drink less than 28 grams of alcohol daily.I'm sorry, but the criterion you provided is incomplete. Could you please provide the full description of the criterion?I regularly take anti-inflammatory medications like aspirin or NSAIDs.I am not willing to undergo blood draws or provide stool samples.You have been eating foods with added inulin (a type of fiber) every day for the past month.You are allergic to the ingredients used in the vaccine, such as thimerosal and enteric-coated capsules.
- Group 1: Inulin and Ty21a Vaccine
- Group 2: Maltodextrin and Ty21a Vaccine
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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."
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."
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."
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."
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."
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."
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