Sleep Duration for Fecal Microbiota

Recruiting at 2 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Danisco

Must not be taking: Sleep aids, SSRIs, Stimulants, others

Disqualifiers: Sleep disorders, GI disorders, Neurodegenerative, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

174 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sleep affects gut bacteria and overall gut health by studying people with different sleep habits. Participants will either increase or decrease their sleep time by 1.5 hours each night for two weeks. Ideal candidates either sleep 5–6 hours and often feel sleepy or sleep 7–8 hours and don’t feel the need for naps. The study aims to determine how changes in sleep patterns can alter gut bacteria in people with different baseline sleep habits. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on the connection between sleep and gut health.

Do I need to stop taking my current medications to join the trial?

The trial requires that you do not use certain medications or supplements that affect sleep or the microbiome, such as sleep aids, SSRIs, and antibiotics, within specific time frames before joining. If you are on such medications, you may need to stop taking them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that altering sleep duration can affect gut health. Increasing sleep by 90 minutes might change gut bacteria types, as studies suggest. Some changes could link to health issues, but strong evidence of serious negative effects is lacking.

Conversely, reducing sleep by 90 minutes has been associated with harmful gut bacteria due to irregular sleep patterns. This could negatively impact gut health, though specific information about serious side effects from less sleep is unavailable.

The trial is in a "Not Applicable" phase, focusing on observing effects rather than testing a new drug, indicating expected safety. Overall, changing sleep duration doesn't seem to pose major safety concerns, but individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how adjusting sleep duration might influence the gut microbiome, which is a unique approach compared to traditional treatments that often focus on diet or probiotics. Unlike other methods that directly alter gut bacteria through supplements or dietary changes, this trial examines how simply increasing or decreasing sleep time could naturally impact gut health. By understanding the connection between sleep and the microbiome, this research could unlock new, non-invasive strategies for promoting gut health and overall well-being.

What evidence suggests that this trial's sleep interventions could be effective for altering fecal microbiota?

This trial will compare the effects of increasing and decreasing sleep duration on gut health. Research has shown that more sleep can positively impact the gut. Studies have found that longer sleep is linked to a wider variety of gut bacteria, which can enhance sleep quality and overall health. Participants in Cohort 1, who will increase their sleep by 90 minutes, may experience these benefits. Conversely, reducing sleep by 90 minutes, as participants in Cohort 2 will do, can disrupt the balance of gut bacteria. Even small changes in sleep routines can affect gut composition. Overall, sleep is crucial for maintaining gut health, and changes in sleep duration can lead to significant shifts in gut health. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people based on their sleep habits. Those who don't get enough sleep will be asked to spend an extra 90 minutes in bed, while those who already sleep sufficiently will reduce their time in bed by the same amount. The study aims to see how these changes affect gut bacteria.

Inclusion Criteria

I have been working at least 30 hours a week for the past 6 months.

BMI 18.5 - 30 kg/m2 (inclusive)

Good physical and mental health as established by self-reported medical history

Exclusion Criteria

I haven't used sleep aids or supplements in the last 4 weeks.

I do not have neurodegenerative diseases like MS, Parkinson's, Alzheimer's, or dementia.

I plan to travel overnight or across time zones during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants' baseline sleep habits and fecal microbiota are assessed

1 week

Sleep Intervention

Participants undergo a sleep intervention where Cohort 1 increases sleep by 1.5 hours and Cohort 2 decreases sleep by 1.5 hours per night

2 weeks

Follow-up

Participants are monitored for changes in fecal microbiota and sleep patterns post-intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Decrease sleep by 90 minutes
• Increase sleep by 90 minutes

Trial Overview The Night Owl Sleep Study is testing how changing sleep duration affects gut bacteria and metabolism. Participants with insufficient or sufficient baseline sleep are assigned more or less bedtime respectively for two weeks to observe changes in fecal microbiota.

How Is the Trial Designed?

Group I: Cohort 1 Active Control 1 Intervention

Cohort 1 are participants who have insufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours more in bed per night.

Group II: Cohort 2 Active Control 1 Intervention

Cohort 2 are participants who have sufficient sleep at baseline; this cohort will be assigned to spend 1.5 hours less in bed per night.

Who Is Running the Clinical Trial?

Danisco

Lead Sponsor

Trials

35

Recruited

3,600+

Citations

1. pharmacytimes.com pharmacytimes.com/view/unbalanced-sleep-patterns-could-impact-gut-bacteria

Unbalanced Sleep Patterns Could Impact Gut Bacteria Researchers found that only a 90-minute difference between sleep time and wake-up time can interfere with gut microbiome composition. They ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6779243/

Gut microbiome diversity is associated with sleep physiology ... We found that total microbiome diversity was positively correlated with increased sleep efficiency and total sleep time, and was negatively ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0944501323001696

Targeting microbiota to alleviate the harm caused by sleep ... Supplementation with probiotics and melatonin can alleviate the related hazards caused by sleep deprivation by regulating intestinal microbiota (Dhaliwal et al.

4. nature.com nature.com/articles/s41598-025-18402-2

Associations between sleep and the gut microbiome in ... Growing evidence suggests that the gut microbiota may mediate the relationship between sleep dysfunction or disrupted circadian rhythm and ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jsr.70125

Sleep Deprivation Alters Gut Microbiome Diversity and ... Sleep deprivation (SD) affects the gut microbiome, but findings across studies vary in terms of microbiota changes, SD induction methods and gut measurements.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07243574

Night Owl Sleep Study: The Effect of Sleep on Fecal ... For 14 days, participants will decrease their nightly sleep by 90 minutes. What is the study measuring? Primary Outcome Measures ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10712199/

Efficacy and safety of fecal microbiota transplantation for ... A pilot study revealed that FMT had a beneficial impact on sleep quality as well as patients' mood of FMT, regardless of gastrointestinal ...

8. kcl.ac.uk kcl.ac.uk/news/irregular-sleep-patterns-harmful-gut-bacteria

Irregular sleep patterns associated with harmful gut bacteria Even a 90-minute difference in the mid-point of sleep can encourage microbiota species which have unfavourable associations with your health.