Fecal microbiota
BiologicalFMT utilizes stool from a healthy donor and puts them into capsules after processing
Other names: FMT
NCT Number: NCT05917379
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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Notify Me18 year–60 year
All sexes
Interventional
Phase 1 / Phase 2
Department of Psychiatry, The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FMT utilizes stool from a healthy donor and puts them into capsules after processing
Other names: FMT
Starch into the same outlook capsule with fecal microbiota
Lactobacillus Helveticas+ Bifidobacterial longum + inulin(3g/day)
Time frame: 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
Time frame: baseline and 1-, 2-, 3-, 6- 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
Time frame: baseline and 1-, 2-, 3-, 6- 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.
Time frame: baseline and 1-month post FMT
Bray-Curtis dissimilarity is a beta diversity metric used to quantify differences in microbial community composition between two time points. A higher dissimilarity score indicates greater divergence in taxonomic profiles. This outcome measures the change in gut microbiota structure from baseline to 1-month after fecal microbiota transplantation (FMT), serving as an index of engraftment and microbial shift
Time frame: baseline and 1 month post FMT
Based on polysomnography (mins)
Time frame: baseline and 1-, 2-, 3-, 6- 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.
Time frame: baseline and 1-, 2-, 3-, 6-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). The total raw score ranges from 20 to 80, and is typically converted to a standard score by multiplying by 1.25 (range: 25 to 100), with higher scores indicating greater severity of depression.
Time frame: baseline and 1-, 2-, 3-, 6-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.
Time frame: baseline and 1-month post FMT
Based on polysomnography (events/h)
Time frame: baseline and 1-month post FMT
Based on polysomnography (mins)
Time frame: baseline and 1-month post FMT
Based on polysomnography (mins)
Time frame: baseline and 1-month post FMT
Observed OTUs (Operational Taxonomic Units) represent the count of unique taxa identified in a sample, reflecting species richness. This outcome measures the number of observed OTUs in fecal samples at baseline and 1-month post-FMT, indicating changes in microbial richness following intervention.
Time frame: baseline and 1-month post FMT
The Shannon index is a commonly used α-diversity metric that accounts for both richness and evenness in microbial communities. Higher values reflect greater diversity. This outcome evaluates within-sample microbial diversity before and after FMT.
Time frame: baseline and 1-month post FMT
The Simpson index measures the probability that two randomly selected individuals in a sample belong to the same species. It is sensitive to dominant taxa. This outcome assesses within-sample microbial diversity changes induced by FMT.
Time frame: baseline and 1-month post FMT
The Chao1 index estimates microbial species richness by accounting for the number of rare taxa (singletons and doubletons). It provides a more robust estimate of total richness compared to observed OTUs. This outcome evaluates the estimated richness change after FMT.
Time frame: baseline and 3-month post FMT
The RBANS consists of 12 subtests that assess five cognitive domains: immediate memory, visuospatial/constructional ability, language, attention, and delayed memory. It yields a Total Scale Index Score with a mean of 100 and a standard deviation of 15, where higher scores indicate better cognitive performance.
RBANS is widely used in clinical and research settings to evaluate cognitive impairment, monitor disease progression, and assess treatment effects. Individual scores can be compared with normative data stratified by age and education level.
Time frame: baseline and 1 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.
Time frame: baseline and 1-month post FMT
IL-1β, IL-6
Time frame: baseline and 1-month post FMT
Automatic nervous system related factors
Time frame: baseline and 1-month post FMT
Automatic nervous system related factors
Peking University Sixth Hospital
Other
The Safety and Efficacy of Fecal Microbiota Transplantation in Patients With Chronic Insomnia Disorder
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