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Night shift Workers' gut bugs under the microscope

NCT ID NCT03221517

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how working night shifts changes the bacteria in your gut and how your body handles sugar. Researchers will compare 12 healthy men who work night shifts with those who work during the day. They will track gut bacteria and blood sugar levels at different times of day to understand why shift workers have higher disease risk.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Standardized meal with glucose challenge test
What this could lead to
If successful, this could reveal how shift work disrupts gut bacteria, pointing toward ways to reduce disease risk in shift workers.
What could go wrong
This is a very small, early observational study with only 12 participants, so findings may not apply broadly. It does not test any treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2017

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 59 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Cohort 1: healthy un-medicated males (to limit gender-induced variability similar to our pilot study), shift-work schedule (\>3 shifts per month outside 7am-6pm (9)) for the past ≥10 years, 40-59 years old (increased prevalence of the metabolic syndrome at ≥60 years of age (20)); * Cohort 2: day workers who work 7am-6pm for ≥10 years matched for line of work, age, gender, and BMI; * Volunteers are capable of giving informed consent; * 40-59 years of age; * Own an android smartphone which installs the remote sensing applications (those with apple smartphones will not be recruited); * Non-smoking; * Male subjects * The use of contraception will NOT be required for male participants. Exclusion Criteria: * Recent travel across more than two (2) time zones (within the past month); * Planned travel across more than two (2) time zones during the planned study activities; * Use of illicit drugs; * High dose vitamins (Vitamin A, Vitamin C, Vitamin E, Beta Carotene, Folic Acid and Selenium), alcohol and any over-the counter NSAID in the (2) two weeks before the start of the 48 hour deep phenotyping; * High fat foods and caffeine in the past 24 hours prior to the 48-hour deep chronotyping session; * History of abdominal surgery; * Known allergy or intolerance to Vancomycin, and/or Neomycin; * Use of anticholinergics in the week prior to the 48-hour sessions; * Use of laxatives or anti-diarrhea medications in the two weeks prior to the 48-hour sessions; * Subjects, who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of ≥ one pint within 8 weeks prior to screening; * Subjects with any abnormal laboratory value or physical finding that according to the investigator may interfere with interpretation of the study results, be indicative of an underlying disease state, or compromise the safety of a potential subject;

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Institute for Translational Medicine and Therapeutics (ITMAT), University of Pennsylvania School of Medicine

    Philadelphia, Pennsylvania, 19104, United States

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