The Safety and Efficacy of FMT in Patients With CID

Depression Clinical Trial

Official title:

The Safety and Efficacy of Fecal Microbiota Transplantation in Patients With Chronic Insomnia Disorder

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05917379
• Other study ID #: PekingUSH 20230518
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: October 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Peking University Sixth Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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"

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 148
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Diagnosed CID by DSM-5

2. 18-60 years old24

3. Body Mass Index (BMI) within the range of 18-24 kg/m²

4. No other pharmacologic treatment in the last month or at the stable maintenance stage (stable dose for more than two months)

5. Communication barrier-free and willing to cooperate with the relevant scales and assessments

6. Willing to participate voluntarily in the survey and able to provide informed consent by signing the consent form

Exclusion Criteria:

1. Currently pregnant, planning pregnancy shortly, or breastfeeding

2. Undergoing or recently received immunosuppressive therapy, or severe immunosuppression (neutrophil count <1500 cells/mm³, lymphocyte count <500 cells/mm³)

3. Diagnosis of one or more specific gastrointestinal disorders (e.g., Crohn's disease, ulcerative colitis, gastrointestinal tumors, pseudomembranous enteritis, gastrointestinal bleeding, enterocutaneous fistula, etc.)

4. Diseases with significant correlations to gut microbiota include Type 2 Diabetes, thyroid disorders, migraines, and autoimmune diseases

5. Ex-/intraintestinal organ infection

6. Abnormal liver or kidney function

7. Faecal occult blood test (+)

8. Suffering from chronic pain, restless leg syndrome, obstructive sleep apnea, or thyroid disorders.

9. Central nervous system disorders (e.g., epilepsy, Parkinson's disease, history of traumatic brain injury, cerebrovascular diseases, etc.)

10. Current smokers or alcohol drinkers

11. History of food or antibiotic allergies

Related Conditions & MeSH terms

• Anxiety
• Cognitive Impairment
• Depression
• Fecal Microbiota Transplantation
• Insomnia Chronic
• Sleep Disorder
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

Biological:
• fecal microbiota
FMT utilizing stool from healthy donor

Locations

Country	Name	City	State
China	Peking University Six Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Sixth Hospital

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep efficiency	(Total Time Asleep / Total Time in Bed×100%) of CID patients will be objectively ,assessed using PSG at week 4 post-FMT (compared to baseline). Additionally, subjective measures including PSQI and ISI scores will be included	4 weeks after intervention
Primary	Occurrence of treatment-related adverse events	Assessing by CTCAE V5.0	4 weeks after the FMT course
Secondary	16sRNA analysis	Alpha diversity indicator: used to describe the internal diversity of microbial communities in fecal samples?Beta diversity indicator: used to compare microbial communities between different fecal samples	baseline and 4-, 8-, and 12-weeks post FMT
Secondary	Pittsburgh Sleep Quality Index,PSQI	The PSQI was used to assess the sleep quality of the participants in the last 1 month. It consists of 19 self-assessments and 5 self-assessment items, of which the 19th self-assessment item and 5 self-assessment items do not participate in the scoring. The 18 items formed 7 components, and each component was scored according to 0-3 levels. The cumulative score of PSQI total score ranged from 0 to 2 l. The higher the score, the worse the sleep quality	baseline and 8?12 weeks and 6?12 months after intervention
Secondary	PSG	Polysomnography was used to assess sleep latency,sleep duration in each period,total sleep time and sleep efficiency	baseline and 8?12 weeks after intervention
Secondary	Insomnia Severity Index,ISI	ISI is a commonly used insomnia severity scale used to assess the extent and impact of individual insomnia in the past two weeks. The ISI consists of seven items, and individuals need to choose the answer best suitable for their condition on each item, and then aggregate the scores of all items to get the total score. The total score ranged from 0 to 28, with higher scores indicating higher insomnia severity. Each item has four answer options, used to describe the frequency of insomnia, severity and effects on the individual.	baseline ? 4?8?12weeks and 6?12 months after intervention
Secondary	Self-Rating Anxiety Scale (SAS)	Participants need to according to the past a period of time (usually in the past week or two weeks), choose a most accord with their feelings answer options, usually expressed by the following level: no or little time (1), part of the time (2 points), quite a large amount of time (3 points), most or all of the time (4 points). An initial assessment of individual anxiety was possible by calculating the total score.	baseline and 4, 8, 12 weeks, and 6, 12 months post-FMT
Secondary	Self-Rating Depression Scale (SDS)	It usually contains 20 topics and is widely used in research and clinical practice. Participants need to according to the past a period of time (usually in the past week or two weeks), choose a most accord with their feelings answer options, usually expressed by the following level: no or little time (1), part of the time (2), quite a large amount of time (3), most or all of the time (4)	baseline and 4, 8, 12 weeks, and 6, 12 months post-FMT
Secondary	Repeatable Battery for the Assessment of Neuropsychological Status,RBANS	The RBANS scale contains 12 sub-tests, and scores can be used to assess individual performance in different cognitive domains and compare with reference groups of peers. It is widely used in clinical and research settings to assess the degree of impairment of cognitive function, course tracking, and evaluation of treatment effects.	baseline and 12 weeks post-FMT
Secondary	Gastrointestinal Symptom Rating Scale,GSRS	The GSRS includes 15 questions about gastrointestinal symptoms covering a range of symptoms including abdominal pain, flatulence, nausea, vomiting, loss of appetite, etc.The score rang from 16-112, the less the better.	baseline and 4 post-FMT
Secondary	Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction, SCOPA-AUT score	The scale is self-completed by patients and consists of 25 items assessing the following domains: gastrointestinal (7), urinary (6), cardiovascular (3), thermoregulatory (4), pupillomotor (1), and sexual (2 items for men and 2 items for women).The score rang from 25-100, the less the better.	baseline and 4, 8, 12 weeks, and 6, 12 months post-FMT
Secondary	Heart Rate Variability ,HRV	Heart rate variability is where the amount of time between your heartbeats fluctuates slightly. Even though these fluctuations are undetectable except with specialized devices, they can still indicate current or future health problems, including heart conditions and mental health issues like anxiety and depression.	baseline and 4-, 8-, and 12-weeks post FMT
Secondary	Multiplex cytokine analysis(pg/mL)	IL-1ß, IL-6, IL-8, TNFa, IL-18, IL-10, IL-22	baseline and 4 weeks post FMT
Secondary	Blood Cortisol Levels(mmol/L)	Hypothalamic-Pituitary-Adrenal (HPA) axis function	baseline and 4 weeks post FMT
Secondary	brain-derived neurotrophic factor ,BDNF(ng/ml)	Cognitive correlation indicators	baseline and 4 weeks post FMT