Phase
Condition
Inflammation
Intra-abdominal Infections
Treatment
Inulin
Maltodextrin
Ty21a Typhoid Fever Vaccine
Clinical Study ID
Ages 18-59 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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
Exclusion
Exclusion Criteria:
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 stoolcontainers)
decline to take an HIV blood test
pregnant or lactating women
refusal to take a pregnancy test
female subjects: refusal to use a method of birth control 1 week prior to theadministration of the vaccine, 1 week during the vaccine, and 1 week after thevaccine
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 channelblockers
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, bacterialvaccine
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 ina 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, autoimmunedisorders, 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 (exceptRecommended Dietary Allowance-level vitamin and mineral supplements), fibersupplements, or food and beverage products containing inulin, chicory root fiber, ormaltodextrin 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
Study Design
Study Description
Connect with a study center
USDA, ARS, Western Human Nutrition Research Center
Davis, California 95616
United StatesActive - Recruiting
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