The Efficacy and Safty of FMT in Patients With CID

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-08

Study Completion Date

2025-07-24

Brief Summary

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This clinical trial aims to learn about the efficacy of fecal microbiota transplantation in patients with chronic insomnia disorder. The main question\[s\] it aims to answer is:

• 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, they will be given the same appearance capsules containing starch.

Researchers will compare the sleep status(PSQI and PSG)of the patients in both groups.

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Detailed Description

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Conditions

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Insomnia Chronic Fecal Microbiota Transplantation Sleep Disorder Depression Anxiety Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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FMT

Investigators have 2 subgroups here, pure Fecal microbiota transplantation-F: 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 placebo B for 45 days from the beginning; Fecal microbiota transplantation+synbiotics-M: 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 Helveticus Bifidobacterium longum + inulin) (3g/day) for 45 days from the beginning.

Group Type EXPERIMENTAL

fecal microbiota

Intervention Type BIOLOGICAL

FMT utilizes stool from a healthy donor and puts them into capsules after processing

synbiotics

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus Helveticas+ Bifidobacterial longum + inulin(3g/day)

Non-FMT

Investigators have 2 subgroups here, synbiotics control-S: 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 beginning; Double Placebo-P: PlaceboA capsules (60 capsules), within 3 days, another 20 placeboA capsules(0.75g stool/capsule) at week 2. Additionally, they will take placebo B for 45 days from the beginning.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Starch into the same outlook capsule with fecal microbiota

synbiotics

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus Helveticas+ Bifidobacterial longum + inulin(3g/day)

Interventions

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fecal microbiota

FMT utilizes stool from a healthy donor and puts them into capsules after processing

Intervention Type BIOLOGICAL

Placebo

Starch into the same outlook capsule with fecal microbiota

Intervention Type OTHER

synbiotics

Lactobacillus Helveticas+ Bifidobacterial longum + inulin(3g/day)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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FMT

Eligibility Criteria

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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)

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No