Status:
RECRUITING
Garden-fresh Foods and Gut Microbiomes
Lead Sponsor:
University of Oregon
Conditions:
Gut Microbiome
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
The purpose of this research is to explore what types of microbes are present on garden-fresh versus store-bought fruits and vegetables, as well as how they might affect the human gut microbiome.
Eligibility Criteria
Inclusion
- \-
Exclusion
- Body mass index (BMI) greater than or equal to 35 or less than or equal to 18.
- Age under 18 or over 45.
- Female who is pregnant or lactating.
- Irregular bowel movements and/or stool consistency.
- Plans to travel, move residences, or other major life change during the study period (August-October 2023).
- Unable to speak, read, and write English.
- Use of any of the following drugs within the last 6 months:
- systemic antibiotics, antifungals, antivirals or antiparasitics (intravenous, intramuscular, or oral);
- oral, intravenous, intramuscular, nasal or inhaled corticosteroids;
- cytokines;
- methotrexate or immunosuppressive cytotoxic agents;
- large doses of commercial probiotics consumed (greater than or equal to 108 cfu or organisms per day) - includes tablets, capsules, lozenges, chewing gum or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, foods do not apply.
- Acute disease at the time of enrollment (defer sampling until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever.
- History of cancer except for squamous or basal cell carcinomas of the skin that have been medically managed by local excision.
- Unstable dietary history as defined by major changes in diet during the previous month, where the subject has eliminated or significantly increased a major food group in the diet.
- Recent history of chronic alcohol consumption defined as more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer or five 5-ounce servings of wine per day.
- Any confirmed or suspected condition/state of immunosuppression or immunodeficiency (primary or acquired) including HIV infection.
- Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the past five years. Any major bowel resection at any time.
- History of active uncontrolled gastrointestinal disorders or diseases including:
- inflammatory bowel disease (IBD) including ulcerative colitis (mild-moderate-severe), Crohn's disease (mild-moderate-severe), or indeterminate colitis;
- irritable bowel syndrome (IBS) (moderate-severe);
- persistent, infectious gastroenteritis, colitis or gastritis, persistent or chronic diarrhea of unknown etiology, Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated);
- chronic constipation.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06506786
Start Date
July 1 2023
End Date
December 31 2024
Last Update
July 17 2024
Active Locations (1)
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1
Institute for Health in the Built Environment, University of Oregon
Eugene, Oregon, United States, 97403