Isolation and Characterization of Multiple Microbial Species From Diverse Healthy Adults

NCT05150184 | Completed

• 1 other identifier: NH10009
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Isolation and characterization of fecal/oral/skin/nasal/throat microbial species from a diverse cohort of healthy adults.

Conditions

Human Microbiome

Outcome Measures

Primary Outcomes (1)

• Analysis of microbiomes from various body sites

  Analysis of microbiomes from various body sites

  within 2 weeks of collection

Study Arms (1)

Healthy adults, various ethnicities

Non-interventional

Other: Non-interventional

Interventions

Non-interventional OTHER

observational study, thus no different arm/groups

Healthy adults, various ethnicities

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy donors of various ethnicities, within normal BMI range.

You may qualify if:

• Voluntary, written, informed consent to participate in the study
• Agreement to comply with the protocol and study restrictions
• Healthy females and males of age 18 to 50 years (inclusive)
• Participants recognize themselves as white or American Indian or Alaska Native or Asian or Black / African American or Native Hawaiian or Other Pacific Islander or Hispanic and Latinos or Multiracial. Participant numbers are limited to a maximum of 10 (males and females) from each group.
• Participants consume \> 4 portions of fruits and vegetables per day and who agree to maintain their usual dietary habits, their usual exercise habits, hygienic habits and their lifestyle in general throughout the trial period
• Females of child-bearing potential who agree to use medically approved methods of birth control
• Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study
• BMI between 18.5-25.

You may not qualify if:

• Participation in a clinical trial with an investigational product or drug within 60 days prior to screening.
• Likeliness to be noncompliant with the protocol, or to be unsuitable to the study as judged by the study staff for any reason.
• Planned major changes in life style (i.e. diet, dieting, exercise level, travelling).
• History of diagnosed eating disorder (anorexia, bulimia).
• Consumption of fast food \> 3 times/week. Where fast food is referred to high carbohydrate and fat rich diet.
• History of drug (\> 2 times per week) during last 2 years or alcohol abuse (\> 08 portions per week for females and 15 portions/week for males, or \>3 portions/day) during the last 3 months.
• Pregnant or breastfeeding women; women planning to become pregnant during the study.
• Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may affect the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness, coronary heart disease/cardiovascular disease or artificial heart valve, HIV, STD, AIDS, hepatitis and autoimmune diseases e.g. MS-disease, thyroid diseases)
• Use of prescription anti-obesity drugs, temporary or irregular medication for diabetes, dyslipidemia or hypertension, non-steroidal anti-inflammatory drugs, corticosteroids, or equivalent immunomodulatory drugs, immunosuppression or ongoing therapy causing immunosuppression and ongoing or recent (last 3 months) antibiotic treatment.
• Diagnosed or suspected organic gastrointestinal disease (e.g. colitis, Crohn's disease, celiac disease, recurrent diverticulitis) or non-organic disease (e.g. IBS), or functional constipation, during the last year.
• Colonoscopy within 3 months before screening
• Colon cleansing within 3 months before screening.
• Gastrointestinal infection within 6 months before screening
• Active or recent (last 3 months) participation in a weight loss program including weight change (increase or loss) of 3 kg during the past three months. History of bariatric surgery.
• History of gingivitis, periodontitis, or any oral disease during last 6 months.

Sponsors & Collaborators

• Danisco: lead
• Reprocell Inc: collaborator
• Serologix: collaborator

Study Sites (1)

Reprocell

Beltsville, Maryland, 20705, United States

Location

Study Officials

• Teresa A Lehman, PhD

  Reprocell

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 9, 2021
• Study Start: November 17, 2021
• Primary Completion: March 23, 2023
• Study Completion: May 23, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

US (1)