Clinical trial NCT05150184: Isolation and Characterization of Multiple Microbial Species From Diverse Healthy Adults
Official title: Isolation and Characterization of Fecal/Oral/Skin/Nasal/Throat Microbial Species From a Diverse Cohort of Healthy Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Microbiome
Lead sponsor: Danisco
Sponsor class: INDUSTRY
Collaborators: name: Reprocell Inc
name: Serologix
First posted: 2021-12-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy donors of various ethnicities, within normal BMI range.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Analysis of microbiomes from various body sites
timeFrame: within 2 weeks of collection
Secondary outcomes:
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: Reprocell
state: Maryland
Study officials:
affiliation: Reprocell
name: Teresa A Lehman, PhD
role: PRINCIPAL_INVESTIGATOR
References: