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Faecal microbiota transplantation for adults with long-term insomnia, compared with placebo

Tests gut bacteria transfer from healthy donors against placebo in adults with chronic insomnia.

Key facts

Who runs it
Chinese University of Hong Kong
Where
Hong Kong, Hong KongSee the site
Trial code
Registry title
FMT for Insomnia Disorder (FMT-SLEEP)
Status
Not yet recruiting
People taking part
74 people, planned
Started
1 Nov 2024
Expected to end
30 Apr 2027
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Faecal Microbiota Transplantation
  • Normal Saline (Placebo)
Record updated
23 September 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with long-term (chronic) insomnia. It tests faecal microbiota transplantation (stool from healthy donors put into the gut) against a salt-water placebo.

Age
18 years and older
Sex
All sexes
Disease stage
Chronic insomnia disorder diagnosed by DSM-5 criteria, moderate or worse, with an ISI (Insomnia Severity Index) score above 14.
Earlier treatment
No change in insomnia treatment or therapy within 4 weeks. No antibiotics, probiotics or prebiotics within 4 weeks.

Main reasons for not taking part

  • Another sleep disorder that disrupts sleep, such as restless legs syndrome or circadian rhythm sleep disorder, or doing shift work
  • Needing urgent psychiatric care, or a suicide attempt in the past 6 months
  • Severe organ failure, kidney failure on dialysis, HIV infection, or active cancer
  • Past abdominal surgery, or reasons you cannot have a GI endoscopy (a camera test of the gut)
  • Known pregnancy, being in another interventional study, or being unable to give consent

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 1. Individuals aged 18 and above
  • 2. Subjects who were diagnosed with chronic insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and with moderate or above insomnia disorder defined as ISI > 14

Who cannot take part

  • 3. Change of treatment or therapy for insomnia within 4 weeks
  • 6. Had abdominal surgery
  • 1. Having an additional sleep disorder, such as restless legs syndrome, or circadian rhythm sleep disorder, that can significantly disrupt the sleep cycle as ascertained by Diagnostic Interview for Sleep Patterns and Disorders (DISP)
  • 2. Requiring immediate psychiatric care (e.g., imminently suicidal subjects) or have attempted suicide in the past 6 months
  • 4. Known history of severe organ failure (including decompensated cirrhosis), renal failure on dialysis, suffering from human immunodeficiency virus infection
  • 5. Confirmed active malignancy
  • 7. Contraindications to GI endoscopy
  • 8. On shift work
  • 9. Taking antibiotics, probiotic or prebiotic preparations within 4 weeks
  • 10. Known pregnancy
  • 11. Mental retardation or inability to provide informed consent
  • 12. Are participating in other interventional studies

Where in Hong Kong

  • Prince of Wales HospitalHong Kong, Hong KongContact: Yun WangNot yet recruiting

About the trial

What the trial wants to find out

Insomnia disorder is characterized by difficulty initiating or maintaining sleep, or early morning awakening accompanied by symptoms such as irritability or fatigue during wakefulness. It is one of the most prevalent health concerns in the population and in clinical practice, with more than one-third of adults experience transient insomnia at some point in their lives. In about 40% of cases, insomnia can develop into a more chronic condition. The COVID-19 pandemic has further aggravated sleep problems, with a reported global prevalence of sleep disturbances reaching 40-49%. The implications of insomnia disorder are substantial, encompassing social, economic, psychological, and physical aspects.

Read full original descriptionShow less

Behavioural, cognitive, and pharmacological interventions can all be effective for insomnia. Pharmacological treatment is commonly used but may have drawbacks such as adverse events and inconclusive safety data for certain medications. Many licensed drugs can be effective in the acute treatment of insomnia but are associated with poor tolerability, or information about long-term effects is not available. Alternatively, cognitive behavioural therapy for insomnia (CBT-I), has been recommended as the first-line treatment for chronic insomnia in adults of any age according to the American and European guidelines. But issue of accessibility, compliance/adherence, and moderate response limit the practicality and applicability of CBT-I.

Recent evidence suggests that the gut microbiota plays a role in regulating sleep behaviour, both directly and indirectly. This has led to the exploration of gut microbiota modulation as a potential therapy for insomnia. Faecal microbiota transplantation (FMT), which is the infusion of faeces from healthy donors to the gut of affected subjects, has shown impressive therapeutic effects for various diseases. Several real-world studies have demonstrated improvements in symptoms of insomnia disorder following FMT. One previous study also indicated the potential of FMT in alleviating post-COVID insomnia. In this randomised, double-blind, placebo-controlled trial, the investigators aim to assess the efficacy of FMT in improving insomnia disorder. Two groups will be recruited in 1:1 ratio. The intervention group will receive FMT while the control group will receive normal saline as placebo. Both groups will have the same assessments.

The 2 groups in the trial

  • Faecal Microbiota TransplantationTreatment being tested

    FMT will be reconstituted from healthy donor's stool

  • PlaceboSham treatment, for comparison

    Subjects will receive 0.9% sodium chloride solution (normal saline) as placebo identical looking with FMT

    Treatment: Normal Saline (Placebo)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Faecal Microbiota Transplantation for Insomnia Disorder: a Randomized, Double-blind, Placebo-controlled Trial
Plain-language title
Faecal microbiota transplantation for adults with long-term insomnia, compared with placeboGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
23 September 2024