Isolation and Characterization of Multiple Microbial Species From Diverse Healthy Adults (IsoMic)

Isolation and Characterization of Fecal/Oral/Skin/Nasal/Throat Microbial Species From a Diverse Cohort of Healthy Adults

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

Study Overview

• Status: Completed
• Conditions: Human Microbiome
• Intervention / Treatment: Other: Non-interventional

Detailed Description

This study aims at isolation and characterizing microbial species from the diverse cohort for future development as next generation probiotics and includes the characterization of the human fecal/oral/skin/nasal and throat microbiome.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • Reprocell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Healthy donors of various ethnicities, within normal BMI range.

Description

Inclusion Criteria:

1. Voluntary, written, informed consent to participate in the study
2. Agreement to comply with the protocol and study restrictions
3. Healthy females and males of age 18 to 50 years (inclusive)
4. 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.
5. 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
6. Females of child-bearing potential who agree to use medically approved methods of birth control
7. Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study
8. BMI between 18.5-25.

Exclusion Criteria:

1. Participation in a clinical trial with an investigational product or drug within 60 days prior to screening.
2. Likeliness to be noncompliant with the protocol, or to be unsuitable to the study as judged by the study staff for any reason.
3. Planned major changes in life style (i.e. diet, dieting, exercise level, travelling).
4. History of diagnosed eating disorder (anorexia, bulimia).
5. Consumption of fast food > 3 times/week. Where fast food is referred to high carbohydrate and fat rich diet.
6. 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.
7. Pregnant or breastfeeding women; women planning to become pregnant during the study.
8. 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)
9. 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.
10. 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.
11. Colonoscopy within 3 months before screening
12. Colon cleansing within 3 months before screening.
13. Gastrointestinal infection within 6 months before screening
14. 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.
15. History of gingivitis, periodontitis, or any oral disease during last 6 months.
16. History of smoking or tobacco use in any form and/or electronic cigarette during the last 6 months.
17. History of skin diseases (e.g. atopic dermatitis (Eczema), hives, dermatitis, psoriasis, or rashes) during the last 6 months.
18. History of SARS CoV-2 infection.
19. Participants under administrative or legal supervision.
20. Other reasons that, in the opinion of the Investigator, make the participant unsuitable for enrollment

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy adults, various ethnicities; Non-interventional	Other: Non-interventional; observational study, thus no different arm/groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of microbiomes from various body sites	Analysis of microbiomes from various body sites	within 2 weeks of collection

Collaborators and Investigators

• Sponsor: Danisco
• Collaborators: Reprocell Inc; Serologix
• Investigators: Principal Investigator: Teresa A Lehman, PhD, Reprocell

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2021
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NH10009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided as of now

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No