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The Safety and Efficacy of FMT in Patients With CID Transplantation in Patients With Chronic Insomnia Disorder

Primary Purpose

Insomnia Chronic, Fecal Microbiota Transplantation, Sleep Disorder

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
fecal microbiota
Sponsored by
Peking University Sixth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of chronic insomnia disorder 18 and ≤65 years old Must be able to swallow tablets and capsules Volunteer for the survey and sign the consent form Exclusion Criteria: Current pregnancy or planned to be pregnant or breastfeeding in the near future Severe immunosuppression (neutrophils <1500 / mm3, lymphocytes <500 / mm3) Infective diseases that must use broad-spectrum antibiotics One or more clearly diagnosed intestinal diseases (Crohn's disease, ulcerative colitis, intestinal tumor, pseudomembranous enteritis, severe gastrointestinal bleeding, high-flow intestinal fistula) Fecal occult blood (+) Chronic pain Restrestless syndrome Obstructive sleep apnea syndrome Food allergy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    FMT+Synbiotics

    Placebo A +Placebo B

    FMT + Placebo B

    Placebo A+Synbiotics

    Arm Description

    Fecal microbiota capsules(0.75g stool/capsule) (10/day), for 3 days, meanwhile synbiotics(2g/day) for 14 days, another 15 fecal microbiota capsules(0.75g stool/capsule) at week 2

    Placebo A-capsules 10/day, for 3 days, meanwhile placebo B-vitamin C (2g/day) for 14 days, another 15 Placebo A at week 2

    Fecal microbiota capsules (0.75g stool/capsule)(10/day), for 3 days, meanwhile placebo vitamin C (2g/day) for 14 days, another 15 fecal microbiota capsules(0.75g stool/capsule) at week 2

    Placebo capsules 10/day, for 3 days, meanwhile synbiotics(2g/day) for 14 days, another 15 Placebo A at week 2

    Outcomes

    Primary Outcome Measures

    PSQI
    The Pittsburgh Sleep Quality Index was used to assess the sleep quality of the participants in the last 1 month
    PSG
    Polysomnography was used to assess sleep latency,sleep duration in each period,total sleep time and sleep efficiency
    16sRNA
    Feces were tested at 16S rRNA for the Alpha diversity indicator (alpha/beta diversity)
    Safety and Tolerability
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Secondary Outcome Measures

    multiple cytokines and stress level
    Blood samples were performed for IL-6、IL-15、IL-17、GM-CSF、TNFα、IL-4、IL-10、IL-14、 cortisol; Urine sample for NE level of 24 hours
    PSQI
    The Pittsburgh Sleep Quality Index was used to assess the sleep quality of the participants in the last 1 month
    PSG
    Polysomnography was used to assess sleep latency,sleep duration in each period,total sleep time and sleep efficiency
    16sRNA
    Feces were tested at 16S rRNA for the Alpha diversity indicator(alpha/beta diversity)
    SDS
    Self-Rating Depression Scale(SDS)，depression severity = cumulative score of each item / 80. Results: no depression was found in patients below 0.5, mild to mild depression in 0.5, moderate to severe depression in 0.6, and severe depression in patients above 0.7.
    SAS
    Self-Rating Anxiety Scale（SAS），The score of 20 items is added to get the coarse score (X). After the formula conversion, that is, after the rough score is multiplied by 1.25, the integer part is taken, and the standard score (Y) is obtained.The cut-off value of SAS standard deviation was 50 points, of which 50-59 points were mild anxiety, 60-69 points were moderate anxiety, and 69 points were severe anxiety.
    cognitive founction
    Montreal Cognitive Assessment(MoCA) score(0-30),higher scores means better cognitive function

    Full Information

    First Posted
    May 25, 2023
    Last Updated
    June 15, 2023
    Sponsor
    Peking University Sixth Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05917379
    Brief Title
    The Safety and Efficacy of FMT in Patients With CID Transplantation in Patients With Chronic Insomnia Disorder
    Official Title
    The Safety and Efficacy of Fecal Microbiota Transplantation in Patients With Chronic Insomnia Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2025 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University Sixth Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to learn about The safety and efficacy of fecal microbiota transplantation in patients with chronic insomnia disorder. The main question[s] it aims to answer are: Safety of the FMT oral capsule pathway in the clinical treatment of chronic insomnia Effectiveness of the FMT oral capsule route for patients with chronic insomnia Participants in the intervention group will be given FMT by boral capsule pathway, and in the control group will be given the same appearance capsules containing vitamins. Researchers will compare the sleep status(PSQI and PSG)of the patients in both groups.
    Detailed Description
    Donors management and FMT oral capsule used here will be prepared according to the "International consensus conference on Stool Banking for fecal microbiota transplantation in clinical practice"

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia Chronic, Fecal Microbiota Transplantation, Sleep Disorder, Depression, Anxiety, Cognitive Impairment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FMT+Synbiotics
    Arm Type
    Experimental
    Arm Description
    Fecal microbiota capsules(0.75g stool/capsule) (10/day), for 3 days, meanwhile synbiotics(2g/day) for 14 days, another 15 fecal microbiota capsules(0.75g stool/capsule) at week 2
    Arm Title
    Placebo A +Placebo B
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo A-capsules 10/day, for 3 days, meanwhile placebo B-vitamin C (2g/day) for 14 days, another 15 Placebo A at week 2
    Arm Title
    FMT + Placebo B
    Arm Type
    Active Comparator
    Arm Description
    Fecal microbiota capsules (0.75g stool/capsule)(10/day), for 3 days, meanwhile placebo vitamin C (2g/day) for 14 days, another 15 fecal microbiota capsules(0.75g stool/capsule) at week 2
    Arm Title
    Placebo A+Synbiotics
    Arm Type
    Active Comparator
    Arm Description
    Placebo capsules 10/day, for 3 days, meanwhile synbiotics(2g/day) for 14 days, another 15 Placebo A at week 2
    Intervention Type
    Biological
    Intervention Name(s)
    fecal microbiota
    Intervention Description
    FMT utilizing stool from healthy donor
    Primary Outcome Measure Information:
    Title
    PSQI
    Description
    The Pittsburgh Sleep Quality Index was used to assess the sleep quality of the participants in the last 1 month
    Time Frame
    6 weeks after intervention
    Title
    PSG
    Description
    Polysomnography was used to assess sleep latency,sleep duration in each period,total sleep time and sleep efficiency
    Time Frame
    6 weeks after intervention
    Title
    16sRNA
    Description
    Feces were tested at 16S rRNA for the Alpha diversity indicator (alpha/beta diversity)
    Time Frame
    6 weeks after intervention
    Title
    Safety and Tolerability
    Description
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    Time Frame
    6 week after intervention
    Secondary Outcome Measure Information:
    Title
    multiple cytokines and stress level
    Description
    Blood samples were performed for IL-6、IL-15、IL-17、GM-CSF、TNFα、IL-4、IL-10、IL-14、 cortisol; Urine sample for NE level of 24 hours
    Time Frame
    6 weeks after intervention
    Title
    PSQI
    Description
    The Pittsburgh Sleep Quality Index was used to assess the sleep quality of the participants in the last 1 month
    Time Frame
    10、14 weeks and 6、12 months after intervention
    Title
    PSG
    Description
    Polysomnography was used to assess sleep latency,sleep duration in each period,total sleep time and sleep efficiency
    Time Frame
    10、14 weeks after intervention
    Title
    16sRNA
    Description
    Feces were tested at 16S rRNA for the Alpha diversity indicator(alpha/beta diversity)
    Time Frame
    10、14 weeks and 6、12 months after intervention
    Title
    SDS
    Description
    Self-Rating Depression Scale(SDS)，depression severity = cumulative score of each item / 80. Results: no depression was found in patients below 0.5, mild to mild depression in 0.5, moderate to severe depression in 0.6, and severe depression in patients above 0.7.
    Time Frame
    6、10、14 weeks and 6、12 months after intervention
    Title
    SAS
    Description
    Self-Rating Anxiety Scale（SAS），The score of 20 items is added to get the coarse score (X). After the formula conversion, that is, after the rough score is multiplied by 1.25, the integer part is taken, and the standard score (Y) is obtained.The cut-off value of SAS standard deviation was 50 points, of which 50-59 points were mild anxiety, 60-69 points were moderate anxiety, and 69 points were severe anxiety.
    Time Frame
    6、10、14 weeks and 6、12 months after intervention
    Title
    cognitive founction
    Description
    Montreal Cognitive Assessment(MoCA) score(0-30),higher scores means better cognitive function
    Time Frame
    14 weeks and12 months after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of chronic insomnia disorder 18 and ≤65 years old Must be able to swallow tablets and capsules Volunteer for the survey and sign the consent form Exclusion Criteria: Current pregnancy or planned to be pregnant or breastfeeding in the near future Severe immunosuppression (neutrophils <1500 / mm3, lymphocytes <500 / mm3) Infective diseases that must use broad-spectrum antibiotics One or more clearly diagnosed intestinal diseases (Crohn's disease, ulcerative colitis, intestinal tumor, pseudomembranous enteritis, severe gastrointestinal bleeding, high-flow intestinal fistula) Fecal occult blood (+) Chronic pain Restrestless syndrome Obstructive sleep apnea syndrome Food allergy.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    After the publication of the research results, the data will be shared on this website and relevant journal platforms
    IPD Sharing Time Frame
    1st December 2025
    IPD Sharing Access Criteria
    Open assess
    Citations:
    PubMed Identifier
    36099873
    Citation
    Wang Z, Wang Z, Lu T, Chen W, Yan W, Yuan K, Shi L, Liu X, Zhou X, Shi J, Vitiello MV, Han Y, Lu L. The microbiota-gut-brain axis in sleep disorders. Sleep Med Rev. 2022 Oct;65:101691. doi: 10.1016/j.smrv.2022.101691. Epub 2022 Aug 31.
    Results Reference
    background
    PubMed Identifier
    36721179
    Citation
    Wang X, Wang Z, Cao J, Dong Y, Chen Y. Gut microbiota-derived metabolites mediate the neuroprotective effect of melatonin in cognitive impairment induced by sleep deprivation. Microbiome. 2023 Jan 31;11(1):17. doi: 10.1186/s40168-022-01452-3.
    Results Reference
    background
    PubMed Identifier
    36115372
    Citation
    Perlis ML, Posner D, Riemann D, Bastien CH, Teel J, Thase M. Insomnia. Lancet. 2022 Sep 24;400(10357):1047-1060. doi: 10.1016/S0140-6736(22)00879-0. Epub 2022 Sep 14.
    Results Reference
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    PubMed Identifier
    33177907
    Citation
    Li Y, Zhang B, Zhou Y, Wang D, Liu X, Li L, Wang T, Zhang Y, Jiang M, Tang H, Amsel LV, Fan F, Hoven CW. Gut Microbiota Changes and Their Relationship with Inflammation in Patients with Acute and Chronic Insomnia. Nat Sci Sleep. 2020 Nov 5;12:895-905. doi: 10.2147/NSS.S271927. eCollection 2020.
    Results Reference
    background
    PubMed Identifier
    32047093
    Citation
    Haifer C, Kelly CR, Paramsothy S, Andresen D, Papanicolas LE, McKew GL, Borody TJ, Kamm M, Costello SP, Andrews JM, Begun J, Chan HT, Connor S, Ghaly S, Johnson PD, Lemberg DA, Paramsothy R, Redmond A, Sheorey H, van der Poorten D, Leong RW. Australian consensus statements for the regulation, production and use of faecal microbiota transplantation in clinical practice. Gut. 2020 May;69(5):801-810. doi: 10.1136/gutjnl-2019-320260. Epub 2020 Feb 11.
    Results Reference
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    PubMed Identifier
    28087657
    Citation
    Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13.
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    PubMed Identifier
    31563878
    Citation
    Cammarota G, Ianiro G, Kelly CR, Mullish BH, Allegretti JR, Kassam Z, Putignani L, Fischer M, Keller JJ, Costello SP, Sokol H, Kump P, Satokari R, Kahn SA, Kao D, Arkkila P, Kuijper EJ, Vehreschild MJG, Pintus C, Lopetuso L, Masucci L, Scaldaferri F, Terveer EM, Nieuwdorp M, Lopez-Sanroman A, Kupcinskas J, Hart A, Tilg H, Gasbarrini A. International consensus conference on stool banking for faecal microbiota transplantation in clinical practice. Gut. 2019 Dec;68(12):2111-2121. doi: 10.1136/gutjnl-2019-319548. Epub 2019 Sep 28.
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    The Safety and Efficacy of FMT in Patients With CID Transplantation in Patients With Chronic Insomnia Disorder

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