FMT for Insomnia Disorder (FMT-SLEEP)

NCT06606938 | Not Yet Recruiting

• 1 other identifier: FMT-SLEEP
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Chronic Insomnia Disorder

Keywords

Faecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects in remission

  Proportion of subjects in remission (Insomnia Severity Index (ISI) \< 8) by week 8. ISI is a self-report questionnaire used to evaluate the nature, severity and impact of insomnia. Total score ranges from 0 to 28. Higher score indicates more severe insomnia

  week 8

Secondary Outcomes (13)

• Proportion of subjects in remission

  weeks 2, 4, and 24

• Proportion of subjects with response

  weeks 2, 4, 8, and 24

• Change in anxiety symptoms

  weeks 2, 4, 8, and 24

• Change in depression symptoms

  weeks 2, 4, 8, and 24

• Change in daytime sleepiness

  weeks 2, 4, 8, and 24

Study Arms (2)

Faecal Microbiota Transplantation

EXPERIMENTAL

FMT will be reconstituted from healthy donor's stool

Procedure: Faecal Microbiota Transplantation

Placebo

SHAM COMPARATOR

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

Procedure: Normal Saline (Placebo)

Interventions

Faecal Microbiota Transplantation PROCEDURE

FMT at baseline, week 2, week 4

Faecal Microbiota Transplantation

Normal Saline (Placebo) PROCEDURE

Placebo at baseline, week 2, week 4

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Individuals aged 18 and above
• \. 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

You may not qualify if:

• \. 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)
• \. Requiring immediate psychiatric care (e.g., imminently suicidal subjects) or have attempted suicide in the past 6 months
• \. Change of treatment or therapy for insomnia within 4 weeks
• \. Known history of severe organ failure (including decompensated cirrhosis), renal failure on dialysis, suffering from human immunodeficiency virus infection
• \. Confirmed active malignancy
• \. Had abdominal surgery
• \. Contraindications to GI endoscopy
• \. On shift work
• \. Taking antibiotics, probiotic or prebiotic preparations within 4 weeks
• \. Known pregnancy
• \. Mental retardation or inability to provide informed consent
• \. Are participating in other interventional studies

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (15)

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  PMID: 23423416 BACKGROUND

• K Pavlova M, Latreille V. Sleep Disorders. Am J Med. 2019 Mar;132(3):292-299. doi: 10.1016/j.amjmed.2018.09.021. Epub 2018 Oct 4.

  PMID: 30292731 BACKGROUND

• Jahrami HA, Alhaj OA, Humood AM, Alenezi AF, Fekih-Romdhane F, AlRasheed MM, Saif ZQ, Bragazzi NL, Pandi-Perumal SR, BaHammam AS, Vitiello MV. Sleep disturbances during the COVID-19 pandemic: A systematic review, meta-analysis, and meta-regression. Sleep Med Rev. 2022 Apr;62:101591. doi: 10.1016/j.smrv.2022.101591. Epub 2022 Jan 22.

  PMID: 35131664 BACKGROUND

• Sivertsen B, Lallukka T, Salo P, Pallesen S, Hysing M, Krokstad S, Simon Overland. Insomnia as a risk factor for ill health: results from the large population-based prospective HUNT Study in Norway. J Sleep Res. 2014 Apr;23(2):124-32. doi: 10.1111/jsr.12102.

  PMID: 24635564 BACKGROUND

• Grandner MA. Sleep, Health, and Society. Sleep Med Clin. 2022 Jun;17(2):117-139. doi: 10.1016/j.jsmc.2022.03.001. Epub 2022 Apr 22.

  PMID: 35659068 BACKGROUND

• Taddei-Allen P. Economic burden and managed care considerations for the treatment of insomnia. Am J Manag Care. 2020 Mar;26(4 Suppl):S91-S96. doi: 10.37765/ajmc.2020.43008.

  PMID: 32282179 BACKGROUND

• Leger D, Bayon V. Societal costs of insomnia. Sleep Med Rev. 2010 Dec;14(6):379-89. doi: 10.1016/j.smrv.2010.01.003. Epub 2010 Mar 31.

  PMID: 20359916 BACKGROUND

• Leach MJ, Page AT. Herbal medicine for insomnia: A systematic review and meta-analysis. Sleep Med Rev. 2015 Dec;24:1-12. doi: 10.1016/j.smrv.2014.12.003. Epub 2014 Dec 17.

  PMID: 25644982 BACKGROUND

• Pan B, Ge L, Lai H, Hou L, Tian C, Wang Q, Yang K, Lu Y, Zhu H, Li M, Wang D, Li X, Zhang Y, Gao Y, Liu M, Ding G, Tian J, Yang K. The Comparative Effectiveness and Safety of Insomnia Drugs: A Systematic Review and Network Meta-Analysis of 153 Randomized Trials. Drugs. 2023 May;83(7):587-619. doi: 10.1007/s40265-023-01859-8. Epub 2023 Mar 22.

  PMID: 36947394 BACKGROUND

• De Crescenzo F, D'Alo GL, Ostinelli EG, Ciabattini M, Di Franco V, Watanabe N, Kurtulmus A, Tomlinson A, Mitrova Z, Foti F, Del Giovane C, Quested DJ, Cowen PJ, Barbui C, Amato L, Efthimiou O, Cipriani A. Comparative effects of pharmacological interventions for the acute and long-term management of insomnia disorder in adults: a systematic review and network meta-analysis. Lancet. 2022 Jul 16;400(10347):170-184. doi: 10.1016/S0140-6736(22)00878-9.

  PMID: 35843245 BACKGROUND

• Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2):125-33. doi: 10.7326/M15-2175. Epub 2016 May 3.

  PMID: 27136449 BACKGROUND

• Riemann D, Espie CA, Altena E, Arnardottir ES, Baglioni C, Bassetti CLA, Bastien C, Berzina N, Bjorvatn B, Dikeos D, Dolenc Groselj L, Ellis JG, Garcia-Borreguero D, Geoffroy PA, Gjerstad M, Goncalves M, Hertenstein E, Hoedlmoser K, Hion T, Holzinger B, Janku K, Jansson-Frojmark M, Jarnefelt H, Jernelov S, Jennum PJ, Khachatryan S, Krone L, Kyle SD, Lancee J, Leger D, Lupusor A, Marques DR, Nissen C, Palagini L, Paunio T, Perogamvros L, Pevernagie D, Schabus M, Shochat T, Szentkiralyi A, Van Someren E, van Straten A, Wichniak A, Verbraecken J, Spiegelhalder K. The European Insomnia Guideline: An update on the diagnosis and treatment of insomnia 2023. J Sleep Res. 2023 Dec;32(6):e14035. doi: 10.1111/jsr.14035.

  PMID: 38016484 BACKGROUND

• Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.

  PMID: 28875581 BACKGROUND

• Lau RI, Su Q, Ching JYL, Lui RN, Chan TT, Wong MTL, Lau LHS, Wing YK, Chan RNY, Kwok HYH, Ho AHY, Tse YK, Cheung CP, Li MKT, Siu WY, Liu C, Lu W, Wang Y, Chiu EOL, Cheong PK, Chan FKL, Ng SC. Fecal Microbiota Transplantation for Sleep Disturbance in Post-acute COVID-19 Syndrome. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2487-2496.e6. doi: 10.1016/j.cgh.2024.06.004. Epub 2024 Jun 20.

  PMID: 38908733 BACKGROUND

• Fang H, Yao T, Li W, Pan N, Xu H, Zhao Q, Su Y, Xiong K, Wang J. Efficacy and safety of fecal microbiota transplantation for chronic insomnia in adults: a real world study. Front Microbiol. 2023 Nov 21;14:1299816. doi: 10.3389/fmicb.2023.1299816. eCollection 2023.

  PMID: 38088972 BACKGROUND

MeSH Terms

Interventions

Fecal Microbiota Transplantation; Saline Solution

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Siew Chien Ng, PhD,FRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Wang

CONTACT

85235051519; 1155202358@link.cuhk.edu.hk

Jessica Ching, PhD

CONTACT

85235053524; jessicaching@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Siew Chien NG

Model Details: The intervention group will receive FMT while the control group will receive 0.9% sodium chloride solution (normal saline) as placebo.

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: September 23, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: September 23, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)