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

September 6, 2023 updated by: Danisco

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy adults, various ethnicities
Non-interventional
Other: Non-interventional
observational study, thus no different arm/groups

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Analysis of microbiomes from various body sites
Time Frame: within 2 weeks of collection
Analysis of microbiomes from various body sites
within 2 weeks of collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Danisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Reprocell Inc
Serologix

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Teresa A Lehman, PhD, Reprocell

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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