The Efficacy and Safty of FMT in Patients With CID

Peking University Sixth Hospital

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cognitive Impairment; Sleep Disorder; Depression; Anxiety; Fecal Microbiota Transplantation; Insomnia Chronic

Treatments: Biological: fecal microbiota; Dietary Supplement: synbiotics; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05917379

PekingUSH 20241218

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

FMT

Experimental group

Description:

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.

Treatment:

Dietary Supplement: synbiotics

Biological: fecal microbiota

Non-FMT

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Dietary Supplement: synbiotics