Human MicrobiomeIsoMicNCT05150184
Isolation and Characterization of Multiple Microbial Species From Diverse Healthy Adults
An observational study of Human Microbiome, run by Danisco at 1 site in United States.
Trial summary
Isolation and characterization of fecal/oral/skin/nasal/throat microbial species from a diverse cohort of healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Human Microbiome
- What is being tested?
- Non-interventional
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2021to 23 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
Study population: Healthy donors of various ethnicities, within normal BMI range.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- History of smoking or tobacco use in any form and/or electronic cigarette during the last 6 months.
- History of skin diseases (e.g. atopic dermatitis (Eczema), hives, dermatitis, psoriasis, or rashes) during the last 6 months.
- History of SARS CoV-2 infection.
- Participants under administrative or legal supervision.
- Other reasons that, in the opinion of the Investigator, make the participant unsuitable for enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Human Microbiome
- Being tested
- Non-interventional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
observational study, thus no different arm/groups
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults, various ethnicities | Non-interventional Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of microbiomes from various body sites
Analysis of microbiomes from various body sites
Measured: within 2 weeks of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start17 Nov 2021
- Primary completion23 Mar 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Reprocell Inc, Serologix
- Responsible party
- Sponsor
- Investigators
- Teresa A Lehman, PhD, Principal investigator, Reprocell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150184
- Sponsor's protocol ID
- NH10009
- Acronym
- IsoMic
- Status last verified
- Sep 2023
- First submitted
- 24 Nov 2021
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided as of now
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolation and Characterization of Fecal/Oral/Skin/Nasal/Throat Microbial Species From a Diverse Cohort of Healthy Adults
- ClinicalTrials.gov ID
- NCT05150184
- Acronym / sponsor ID
- IsoMic / NH10009
- Conditions
- Human Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Collaborators
- Reprocell Inc, Serologix
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults, various ethnicities | – | Other: Non-interventionalNon-interventional |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy donors of various ethnicities, within normal BMI range.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventionalobservational study, thus no different arm/groups | Other | Healthy adults, various ethnicities |
Primary outcome
Analysis of microbiomes from various body sites
Time frame: within 2 weeks of collection
Analysis of microbiomes from various body sites
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: Undecided. Undecided as of now
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa A Lehman, PhD principal investigator
Reprocell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Microbiome, run by Danisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of microbiomes from various body sites (time frame: within 2 weeks of collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.