RECRUITING

Garden-fresh Foods and Gut Microbiomes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Microbiomes of Garden-fresh vs Store-bought Produce and Variation in Their Effects on the Human Gut Microbiome

Quick Facts

Study Start:2023-07-01

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06506786

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* 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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* 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.

Contacts and Locations

Study Contact

Gwynne Mhuireach, PhD

CONTACT

541-346-4694

gwynhwyf@uoregon.edu

Principal Investigator

Gwynne Mhuireach, PhD

PRINCIPAL_INVESTIGATOR

University of Oregon

Study Locations (Sites)

Institute for Health in the Built Environment, University of Oregon

Eugene, Oregon, 97403

United States

Collaborators and Investigators

Sponsor: University of Oregon

Gwynne Mhuireach, PhD, PRINCIPAL_INVESTIGATOR, University of Oregon

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-01

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-07-01

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Gut Microbiome