Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606938
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
FMT for Insomnia Disorder FMT-SLEEP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Faecal Microbiota Transplantation for Insomnia Disorder a Randomized Double-blind Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 complianceadherence 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 11 ratio The intervention group will receive FMT while the control group will receive normal saline as placebo Both groups will have the same assessments
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 complianceadherence 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 11 ratio The intervention group will receive FMT while the control group will receive normal saline as placebo Both groups will have the same assessments
Detailed Description:
Insomnia disorder is characterized by difficulty initiating or maintaining sleep or early morning awakening accompanied by daytime symptoms such as irritability or fatigue It is one of the most prevalent health problems 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 social economic psychological and physical implications of insomnia disorder are substantial with evidence linking the condition to an increased risk of hypertension cardiovascular disease anxiety and depression as well as impaired quality of life work absenteeism work-related accidents poor work efficiency and family dysfunction
Behavioural cognitive and pharmacological interventions can all be effective for insomnia Pharmacological treatment is common in practice and widely used for the management of insomnia A recent meta-analysis suggested that Eszopiclone and Lemborexant had the best profile in terms of efficacy acceptability and tolerability However Eszopiclone might cause substantial adverse events and safety data on lemborexant were inconclusive Many licensed drugs including benzodiazepines Z-hypnotics and dual orexin receptor antagonist DORA are prescribed as effective short-term treatment of insomnia but some are associated with poor tolerability or the information about long-term safety effects is not available Alternatively cognitive behavioral 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 issues of accessibility complianceadherence and moderate response also pose limit the practicality and applicability of CBT-I
Growing evidence indicates that the microbiota-gut-brain axis contributes to the regulation of sleep behavior both directly and indirectly and may play a critical role in the etiology and pathogenesis of sleep disorders Sleep loss is capable of altering the gut microbiota composition through increased hunger and decreased physical activity immunomodulation or hypothalamus-pituitary-adrenal HPA axis activation and subsequent intestinal barrier disruption Conversely the gut microbiome is capable of altering sleep through somnogenic lipopolysaccharide LPS and Muramyl peptides translocation vagal afferent excitation in response to enteric LPS regulation of enterochromaffin cell serotonin production and inflammatory cytokine regulation Consequently gut microbiota modulation is a potential therapy for insomnia
According to a preclinical study transplantation of the gut microbiota from mice with sleep disorder into normal mice induced microglia overactivation and neuronal apoptosis in the hippocampus cognitive decline and colonic microbiota disorder Moreover a human study found that fecal microbiota transplantation FMT from healthy donors improved sleep and also ameliorated depression and anxiety in patients with irritable bowel syndrome IBS Another study demonstrated that FMT led to a decrease in the scores of the five components of Pittsburgh Sleep Quality Index PSQI in 52 IBS patients with poor sleep quality including subjective sleep quality sleep latency sleep duration habitual sleep efficiency and sleep disturbances A clinical study showed significantly lower Sleep Disturbance Scale for Children SDSC scores in children with autism after FMT whilst a retrospective study also indicated that FMT could significantly improve the sleep disorder scores in the autistic children with constipation According to a real world study FMT significantly ameliorated the Insomnia Severity Index ISI Pittsburgh Sleep Quality Index PSQI and quality of life in patients with chronic insomnia The results from one previous study also demonstrated that FMT could alleviate post-COVID insomnia
In this randomised double-blind placebo-controlled trial the investigators aim to assess the efficacy of FMT in improving insomnia disorder The investigators hypothesize that FMT is a safe and effective treatment for insomnia disorder
Behavioural cognitive and pharmacological interventions can all be effective for insomnia Pharmacological treatment is common in practice and widely used for the management of insomnia A recent meta-analysis suggested that Eszopiclone and Lemborexant had the best profile in terms of efficacy acceptability and tolerability However Eszopiclone might cause substantial adverse events and safety data on lemborexant were inconclusive Many licensed drugs including benzodiazepines Z-hypnotics and dual orexin receptor antagonist DORA are prescribed as effective short-term treatment of insomnia but some are associated with poor tolerability or the information about long-term safety effects is not available Alternatively cognitive behavioral 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 issues of accessibility complianceadherence and moderate response also pose limit the practicality and applicability of CBT-I
Growing evidence indicates that the microbiota-gut-brain axis contributes to the regulation of sleep behavior both directly and indirectly and may play a critical role in the etiology and pathogenesis of sleep disorders Sleep loss is capable of altering the gut microbiota composition through increased hunger and decreased physical activity immunomodulation or hypothalamus-pituitary-adrenal HPA axis activation and subsequent intestinal barrier disruption Conversely the gut microbiome is capable of altering sleep through somnogenic lipopolysaccharide LPS and Muramyl peptides translocation vagal afferent excitation in response to enteric LPS regulation of enterochromaffin cell serotonin production and inflammatory cytokine regulation Consequently gut microbiota modulation is a potential therapy for insomnia
According to a preclinical study transplantation of the gut microbiota from mice with sleep disorder into normal mice induced microglia overactivation and neuronal apoptosis in the hippocampus cognitive decline and colonic microbiota disorder Moreover a human study found that fecal microbiota transplantation FMT from healthy donors improved sleep and also ameliorated depression and anxiety in patients with irritable bowel syndrome IBS Another study demonstrated that FMT led to a decrease in the scores of the five components of Pittsburgh Sleep Quality Index PSQI in 52 IBS patients with poor sleep quality including subjective sleep quality sleep latency sleep duration habitual sleep efficiency and sleep disturbances A clinical study showed significantly lower Sleep Disturbance Scale for Children SDSC scores in children with autism after FMT whilst a retrospective study also indicated that FMT could significantly improve the sleep disorder scores in the autistic children with constipation According to a real world study FMT significantly ameliorated the Insomnia Severity Index ISI Pittsburgh Sleep Quality Index PSQI and quality of life in patients with chronic insomnia The results from one previous study also demonstrated that FMT could alleviate post-COVID insomnia
In this randomised double-blind placebo-controlled trial the investigators aim to assess the efficacy of FMT in improving insomnia disorder The investigators hypothesize that FMT is a safe and effective treatment for insomnia disorder
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None