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NCT Number: NCT02573753

The Effects of Sleep on Human Microbiota: Implications for Health and Disease

The aggregate of microorganisms inhabiting the human body can be regarded as a dynamic reflector of both healthy and disease states, altering in response to changes in the environment. This may precede clinically detectable disease; and thereby, could be used to predict disease onset and additionally monitor response to treatment and predict prognosis. The primary hypothesis of this pilot study is that the human microbial communities are influenced by sleep and altered in humans with abnormal sleep patterns, and they may ultimately relate to disease risk.

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Key information

Conditions

Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Only subjects who are eligible for ongoing IRB-approved studies will be deemed eligible for this protocol.

Exclusion criteria

  • Pregnant or breast-feeding women
  • Subjects who are ineligible for ongoing IRB-approved studies will not be included in this protocol

Treatment and study plan

Sleep Restriction

Behavioral

Weight gain

Dietary Supplement

Primary outcomes

  1. Changes in human microbiota induced by sleep manipulation in healthy subjects

    Time frame: 1 year

  2. Changes in human microbiota induced by fluctuations in body weight and sleep in healthy subjects

    Time frame: 20 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Hammel

CONTACT

[email protected]

507-255-6676

Nick Wozniak

CONTACT

[email protected]

507-255-8794

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2015
Primary completion
2031
Study completion
2031
First posted
Oct 12, 2015
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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