RecruitingACTRN12620000106932

The Healthy Optimal Australian Microbiome (HOAM) Study


Sponsor

University of New South Wales (UNSW) Sydney

Enrollment

550 participants

Start Date

Feb 17, 2020

Study Type

Observational

Conditions

Summary

Researchers at the Microbiome Research Centre, UNSW Sydney are inviting healthy and active adults to join in a study to help them discover what is the optimal human microbiome-state. The microbiome is the population of microbes occupying various sites on our bodies, and is already known to have a major impact on human health. If we can determine what the normal microbiome of a the supremely healthy person is made up of, then we have the potential to positively change health outcomes for many future generations by using the microbiome as a target for clinical therapies.


Eligibility

Sex: Both males and femalesMin Age: 13 Yearss

Inclusion Criteria83

  • Adolescent Active
  • Participant is aged between 13-18 years old.
  • Participant can provide own consent if over 16, or have consent provided by a responsible person.
  • Participant does not require interpretive language services to communicate in English.
  • Participant is willing and able to provide a stool, blood, urine and oral sample for this study.
  • Participant is willing to undertake the surveys which are part of this study
  • Participant is in good general health.
  • Participant has a balanced and healthy diet.
  • Participant has not taken any antibiotic medication within the past 6 months.
  • Participant is not undergoing any ongoing medical intervention or tests.
  • Participant participates in regular physical activity outside of school
  • Participant has a healthy body weight BMI between the 5th and 85th percentile for age and gender)
  • Participant has no significant past medical history. Participant has not had any surgery (excluding for treatment of bone fractures, or accidental injury).
  • Participant does not regularly take medication for any chronic medical issue.
  • Participant is free of any mental condition including anxiety or depression.
  • Participant does not suffer from pain or stress.
  • Participant on average gets between 9-12 hours of continuous sleep per 24-hour period.
  • Participant does not have chronic, or acute skin condition (ie. Dermatitis, eczema, psoriasis)
  • Adolescent inactive
  • Participant is aged between 13-18 years old.
  • Participant can provide own consent if over 16, or have consent provided by a responsible person.
  • Participant does not require interpretive language services to communicate in English.
  • Participant is willing and able to provide a stool, blood and oral sample for this study.
  • Participant is willing to undertake the surveys which are part of this study
  • Participant is in good general health.
  • Participant has not taken any antibiotic medication within the past 6 months.
  • Participant is not undergoing any ongoing medical intervention or tests.
  • Participant does not participate in regular physical activity outside of school.
  • Participant is overweight or obese (BMI greater than 85th percentile for age and gender)
  • Participant has no significant past medical history.
  • Young adult - active
  • Participant is aged between 19-45 years old.
  • Participant can provide own consent.
  • Participant does not require interpretive language services to communicate in English.
  • Participant is willing and able to provide a stool, blood, urine and oral sample for this study.
  • Participant is in good general health.
  • Participant has not taken any antibiotic medication within the past 6 months.
  • Participant is not undergoing any ongoing medical intervention or tests.
  • Participant participates in regular physical activity >3 hours per week.
  • [Athletic subgroup, participant regularly undertakes physical activity in a competitive, elite or professional capacity]
  • Participant has no significant past medical history.
  • Participant on average gets greater than 7 hours of sleep per night. [Athletic subgroup, this requirement for 7 h of sleep is not applicable]
  • Young adult inactive
  • Participant is aged between 19-45 years old.
  • Participant does not require interpretive language services to communicate in English.
  • Participant can provide own consent.
  • Participant is willing and able to provide a stool, blood, and oral sample for this study.
  • Participant has not taken any antibiotic medication within the past 6 months.
  • Participant does not participate in regular physical activity >3 hours per week.
  • Adult Active
  • Participant is aged between 46-65 years old.
  • Participant can provide own consent.
  • Participant does not require interpretive language services to communicate in English.
  • Participant is willing and able to provide a stool, blood, and oral sample for this study.
  • Participant is in good general health.
  • Participant has not taken any antibiotic medication within the past 6 months.
  • Participant is not undergoing any ongoing medical intervention or tests.
  • Participant participates in regular physical activity >3 hours per week.
  • Participant has no significant past medical history.
  • Participant on average gets greater than 7 hours of sleep per night.
  • Adult inactive
  • Participant is aged between 46-65 years old.
  • Participant is able to provide own consent.
  • Participant does not require interpretive language services to communicate in English.
  • Participant is willing and able to provide a stool, blood, urine and oral sample for this study.
  • Participant has not taken any antibiotic medication within the past 6 months.
  • Participant does not participate in regular physical activity >3 hours per week.
  • Senior adult
  • Participant Is aged between 66-94 years old.
  • Participant can provide own consent or have consent provided for them legally
  • Participant has not taken any antibiotic medication within the past 6 months.
  • Participant does not require interpretive language services to communicate in English.
  • Participant is willing and able to provide a stool, blood, urine and oral sample for this study.
  • Participant is willing and able to complete the questionnaire-based and physical assessments in this study.
  • Very senior adult
  • Participant is greater than 95 years old.
  • Participant can provide own consent or have consent provided for them legally
  • Participant has not taken any antibiotic medication within the past 6 months.
  • Participant does not require interpretive language services to communicate in English.
  • Participant is willing and able to provide a stool, blood and oral sample for this study.
  • Participant is willing and able to complete the questionnaire-based and physical assessments in this study
  • Senior and very senior adult dementia groups
  • as for each respective group plus participant has a diagnosis of dementia by a medical doctor.

Exclusion Criteria147

  • Adolescent active
  • Participant is not aged between 13-18 years old
  • Participant does not regularly exercise outside of school
  • Accessibility and consent exclusions
  • Participant is not able to provide own consent or have consent provided for them legally
  • Participant requires interpretive language services to communicate in English
  • Participant is not willing and able to provide a stool, blood and oral sample for this study.
  • Participant is not willing and able to complete the questionnaire-based and physical assessments in this study.
  • Participant consumes more than one standard alcoholic beverage per day on average and/or consumes more than 4 standard drinks on one occasion.
  • Participant smokes or uses vapour-producing devices containing tobacco or other combustible or vaporisable products (including Cannabis in any form) intended for direct inhalation into the lungs.
  • Participant has made a major change to diet in the past month prior to enrolment
  • Participant suffers from acute or chronic medical ailment
  • Participant has a history of disease, cancer, or congenital abnormality
  • Participant has developmental delay, or behavioural condition (e.g. attention deficit disorder, attention deficit/hyperactivity disorder, autism spectrum disorder, Asperger syndrome)
  • Participant resides in same home (and uses the same toilet) as someone who uses chemotherapy, immunosuppressive, antineoplastic or cytotoxic agents
  • Participant has had previous surgeries (excluding for treatment of bone fractures, or accidental injury)
  • Participant has previously suffered from/currently suffers from a mental condition including anxiety or depression
  • Participant regularly takes medication for a chronic medical issue including topical, inhaled, oral, injectable medications
  • Participant regularly suffers from chronic or acute pain
  • Participant suffers from chronic or acute stress
  • Participant suffers from insomnia
  • Participant has chronic illness such as asthma
  • Participant has diagnosed food allergy or intolerance
  • Participant has experienced recent cause of grief or trauma, or is experiencing ongoing mental distress (i.e. School bullying, domestic violence)
  • Adolescent inactive
  • Participant is not aged between 13-18 years old
  • Participant is not overweight or obese (BMI <85th percentile for age and sex)
  • Participant engages in regular physical activity outside of school in addition to school-based activities.
  • Participant is not able to provide own consent or have consent provided for them legally
  • Participant requires interpretive language services to communicate in English
  • Participant is not willing and able to provide a stool, blood, urine and oral sample for this study.
  • Participant is not willing and able to complete the questionnaire-based and physical assessments in this study.
  • Participant consumes more than one standard alcoholic beverage per day on average and/or consumes more than 4 standard drinks on one occasion.
  • Participant smokes or uses vapour-producing devices containing tobacco or other combustible or vaporisable products (including Cannabis in any form) intended for direct inhalation into the lungs.
  • Participant has made a major change to diet in the past month prior to enrolment
  • Young adult active
  • Participant is not aged between 19-45 years old.
  • Participant does not regularly exercise greater than 3 hours per week.
  • [Subgroup, Professional and semi-professional athletes
  • Participant does not undertake sport at a professional or semi-professional level]
  • Participant is not able to provide own consent
  • Participant requires interpretive language services to communicate in English
  • Participant is not willing and able to provide a stool, blood and oral sample for this study.
  • Participant is not willing and able to complete the questionnaire-based and physical assessments in this study.
  • Participant consumes more than one standard alcoholic beverage per day on average and/or consumes more than 4 standard drinks on one occasion.
  • Participant smokes or uses vapour-producing devices containing tobacco or other combustible or vaporisable products (including Cannabis in any form) intended for direct inhalation into the lungs.
  • Participant has made a major change to diet in the past month prior to enrolment
  • Participant has taken any antibiotic medication within the past 3 months.
  • Participant is undergoing ongoing medical intervention or tests.
  • Participant suffers from acute or chronic illness of any description.
  • Participant has a history of disease, cancer, or congenital abnormality.
  • Participant is dependent on medication for an acute or chronic illness, ongoing medical condition or complaint.
  • Participant regularly suffers from chronic or acute pain.
  • Participant has diagnosed food allergy or intolerance.
  • Participant has experienced recent cause of grief or trauma.
  • Participant is pregnant or is within 1-year post-pregnancy.
  • Participant is lactating, and/or currently breastfeeding.
  • Participant has undergone any major surgery within lifetime (excludes orthopaedic and dental surgery).
  • Participant suffers from chronic, or acute skin condition (ie. Dermatitis, eczema, psoriasis).
  • Participant has undergone major GI surgery such as bowel resection other previous bariatric procedure
  • Young adult inactive
  • Participant is not aged between 19-45 years old.
  • Participant engages in regular physical activity >3 hours per week.
  • Participant is not able to provide own consent
  • Participant requires interpretive language services to communicate in English
  • Participant is not willing and able to provide a stool, blood, urine and oral sample for this study.
  • Participant is not willing and able to complete the questionnaire-based and physical assessments in this study.
  • Participant consumes more than one standard alcoholic beverage per day on average and/or consumes more than 4 standard drinks on one occasion.
  • Participant smokes or uses vapour-producing devices containing tobacco or other combustible or vaporisable products (including Cannabis in any form) intended for direct inhalation into the lungs.
  • Participant has made a major change to diet in the past month prior to enrolment
  • Participant has taken any antibiotic medication within the past 3 months.
  • Participant has undergone major GI surgery such as bowel resection other previous bariatric procedure
  • [for athlete group, participant does not train for an activity where they compete at a professional or competitive level or engage in high level activity as part of their work]
  • Adult active
  • Group specific exclusions
  • Participant is not aged between 46-65 years old.
  • Participant does not regularly exercise greater than 3 hours per week.
  • Participant is not able to provide own consent
  • Participant requires interpretive language services to communicate in English
  • Participant is not willing and able to provide a stool, urine, blood and oral sample for this study.
  • Participant is not willing and able to complete the questionnaire-based and physical assessments in this study.
  • Participant consumes more than one standard alcoholic beverage per day on average and/or consumes more than 4 standard drinks on one occasion.
  • Participant smokes or uses vapour-producing devices containing tobacco or other combustible or vaporisable products (including Cannabis in any form) intended for direct inhalation into the lungs.
  • Participant has made a major change to diet in the past month prior to enrolment
  • Participant has taken any antibiotic medication within the past 3 months.
  • Participant is undergoing ongoing medical intervention or tests.
  • Participant suffers from acute or chronic illness of any description.
  • Participant has a history of disease, cancer, or congenital abnormality.
  • Participant is dependent on medication for an acute or chronic illness, ongoing medical condition or complaint.
  • Participant regularly suffers from chronic or acute pain.
  • Participant has diagnosed food allergy or intolerance.
  • Participant has experienced recent cause of grief or trauma.
  • Participant is pregnant or is within 1-year post-pregnancy.
  • Participant is lactating, and/or currently breastfeeding.
  • Participant has undergone any major surgery within lifetime (excludes orthopaedic and dental surgery).
  • Participant suffers from chronic, or acute skin condition (ie. Dermatitis, eczema, psoriasis).
  • Participant has undergone major GI surgery such as bowel resection other previous bariatric procedure
  • Athlete
  • As for young adult group plus
  • Participant must be actively training for and competing at a competitive or professional level or be highly active as part of their profession.
  • Adult Inactive
  • Participant is not aged between 46-65 years old.
  • Participant does not regularly exercise greater than 3 hours per week.
  • Participant is not able to provide own consent
  • Participant requires interpretive language services to communicate in English
  • Participant is not willing and able to provide a stool, blood, urine and oral sample for this study.
  • Participant is not willing and able to complete the questionnaire-based and physical assessments in this study.
  • Participant consumes more than one standard alcoholic beverage per day on average and/or consumes more than 4 standard drinks on one occasion.
  • Participant smokes or uses vapour-producing devices containing tobacco or other combustible or vaporisable products (including Cannabis in any form) intended for direct inhalation into the lungs.
  • Participant has made a major change to diet in the past month prior to enrolment
  • Participant has taken any antibiotic medication within the past 3 months.
  • Participant is undergoing ongoing medical intervention or tests.
  • Participant suffers from acute or chronic illness of any description.
  • Participant has a history of disease, cancer, or congenital abnormality.
  • Participant is dependent on medication for an acute or chronic illness, ongoing medical condition or complaint.
  • Participant regularly suffers from chronic or acute pain.
  • Participant has diagnosed food allergy or intolerance.
  • Participant has experienced recent cause of grief or trauma.
  • Participant is pregnant or is within 1-year post-pregnancy.
  • Participant is lactating, and/or currently breastfeeding.
  • Participant has undergone any major surgery within lifetime (excludes orthopaedic and dental surgery).
  • Participant suffers from chronic, or acute skin condition (ie. Dermatitis, eczema, psoriasis).
  • Participant has undergone major GI surgery such as bowel resection other previous bariatric procedure
  • Senior adults
  • Participant is not aged 66-94
  • Participant is not able to provide own consent or have consent provided for them legally
  • Participant requires interpretive language services to communicate in English
  • Participant is not willing and able to provide a stool, blood, urine and oral sample for this study.
  • Participant is not willing and able to complete the questionnaire-based and physical assessments in this study.
  • Participant consumes more than one standard alcoholic beverage per day on average and/or consumes more than 4 standard drinks on one occasion.
  • Participant smokes or uses vapour-producing devices containing tobacco or other combustible or vaporisable products (including Cannabis in any form) intended for direct inhalation into the lungs.
  • Participant has made a major change to diet in the past month prior to enrolment
  • Participant has taken any antibiotic medication within the past 3 months.
  • Participant has undergone major GI surgery such as bowel resection or other previous bariatric procedure.
  • Very senior adults
  • Participant is not able to provide own consent or have consent provided for them legally
  • Participant requires interpretive language services to communicate in English
  • Participant is not willing and able to provide a stool, blood, urine and oral sample for this study.
  • Participant is not willing and able to complete the questionnaire-based and physical assessments in this study.
  • Participant consumes more than one standard alcoholic beverage per day on average and/or consumes more than 4 standard drinks on one occasion.
  • Participant smokes or uses vapour-producing devices containing tobacco or other combustible or vaporisable products (including Cannabis in any form) intended for direct inhalation into the lungs.
  • Participant has made a major change to diet in the past month prior to enrolment
  • Participant has taken any antibiotic medication within the past 3 months.
  • Participant has undergone major GI surgery such as bowel resection or other previous bariatric procedure.
  • Senior adult and very senior adult with dementia
  • As for each respective group where, a Person Responsible can consent for the participant and
  • The participant does not have a diagnosis of dementia from a health professional.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

One timepoint sample only for - Stool Sample - Oral Swab Sample - Blood Sample - Urine sample - Collection of Vital Sign Measurements / BMI / Biometric Impedance Analysis (BIA) scales - Partici

One timepoint sample only for - Stool Sample - Oral Swab Sample - Blood Sample - Urine sample - Collection of Vital Sign Measurements / BMI / Biometric Impedance Analysis (BIA) scales - Participant Demographics & Lifestyle Questionnaire - K10 Assessment (Depression/Anxiety Scale) - International Physical Activity Questionnaire (IPAQ) - Australian Eating Survey - Dietary Assessment - Grip Strength Assessment (Senior Participants) - Sit-Stand Assessment (Senior Participants) - Mini-Mental State Exam (MMSE) / Lawton and Brody of Daily Living scale and iADLS - Cognitive Battery Test (Optional - Adult Participants)


Locations(3)

St George Hospital - Kogarah

NSW, Australia

St George Private Hospital - Kogarah

NSW, Australia

The Sutherland Hospital - Caringbah

NSW, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12620000106932


Related Trials