The Safety and Efficacy of FMT in Patients With CID

Phase 1

Recruiting

• Conditions: Depression; Insomnia Chronic; Fecal Microbiota Transplantation; Anxiety; Cognitive Impairment; Sleep Disorder
• Interventions: Biological: fecal microbiota; Other: Placebo; Dietary Supplement: synbiotics

• Registration Number: NCT05917379
• Lead Sponsor: Peking University Sixth Hospital

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"

Study Timeline

• Study First Submitted: 2023-05-25
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-23
• Study Start: 2023-10-08
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Primary Completion: 2025-10-08
• Study Completion: 2026-10-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FMT（Pure Fecal microbiota transplantation-F)	Placebo	Fecal microbiota capsules(0.75g stool/capsule) (60 capsules), within 3 days, another 20 fecal microbiota capsules(0.75g stool/capsule) at week 2. Additionally, they will take placeboB for 45 days from the begining.
FMT(Fecal microbiota transplantation+synbiotics-M)	synbiotics	Fecal microbiota capsules(0.75g stool/capsule) (60 capsules), within 3 days, another 20 fecal microbiota capsules(0.75g stool/capsule) at week 2. Additionally, they will take synbiotics (Lactobacillus Helveticas+ Bifidobacterial longum + inulin) (3g/day) for 45 days from the begining.
Non-FMT(Synbiotics control-S)	Placebo	PlaceboA capsules (60 capsules), within 3 days, another 20 placeboA capsules(0.75g stool/capsule) at week 2. Additionally, they will take synbiotics (Lactobacillus Helveticas+ Bifidobacterial longum + inulin) (3g/day) for 45 days from the begining.
Non-FMT(Synbiotics control-S)	synbiotics	PlaceboA capsules (60 capsules), within 3 days, another 20 placeboA capsules(0.75g stool/capsule) at week 2. Additionally, they will take synbiotics (Lactobacillus Helveticas+ Bifidobacterial longum + inulin) (3g/day) for 45 days from the begining.
Non-FMT(Total Placebo-P)	Placebo	PlaceboA capsules (60 capsules), within 3 days, another 20 placeboA capsules(0.75g stool/capsule) at week 2. Additionally, they will take placeboBfor 45 days from the begining.
FMT（Pure Fecal microbiota transplantation-F)	fecal microbiota	Fecal microbiota capsules(0.75g stool/capsule) (60 capsules), within 3 days, another 20 fecal microbiota capsules(0.75g stool/capsule) at week 2. Additionally, they will take placeboB for 45 days from the begining.
FMT(Fecal microbiota transplantation+synbiotics-M)	fecal microbiota	Fecal microbiota capsules(0.75g stool/capsule) (60 capsules), within 3 days, another 20 fecal microbiota capsules(0.75g stool/capsule) at week 2. Additionally, they will take synbiotics (Lactobacillus Helveticas+ Bifidobacterial longum + inulin) (3g/day) for 45 days from the begining.

Primary Outcome Measures

Name	Time	Method
Sleep efficiency	1 month post FMT	(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

Secondary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index，PSQI	baseline and 1-, 2-, 3-, 6,-12- months post FMT	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
Insomnia Severity Index，ISI	baseline and 1-, 2-, 3-, 6,-12- months post FMT	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.
16sRNA analysis	baseline and 1-, 2-, and 3-month post FMT	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
PSG	baseline and 2-, and 3-month post FMT	Polysomnography was used to assess sleep latency,sleep duration in each period,total sleep time and sleep efficiency
Self-Rating Anxiety Scale (SAS)	baseline and 1-, 2-, 3-, 6-,12- months post FMT	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.
Self-Rating Depression Scale (SDS)	baseline and 1-, 2-, 3-, 6-,12- months post FMT	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)
Repeatable Battery for the Assessment of Neuropsychological Status，RBANS	baseline and 12-month post FMT	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.
Gastrointestinal Symptom Rating Scale，GSRS	baseline and 1-, 2-, 3-, 6-,12- months post FMT	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.
Heart Rate Variability ,HRV	baseline and 1-, 2-, 3-, 6-,12- months post FMT	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.
Multiplex cytokine analysis(pg/mL)	baseline and 1-month post FMT	IL-1β, IL-6
Ach levels	baseline and 1-month post FMT	Automatic nervous system related factors
NE levels	baseline and 1-month post FMT	Automatic nervous system related factors

Trial Locations

Locations (1)

Peking University Six Hospital; 🇨🇳 Beijing, Beijing, China