FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms

Study Overview
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Brief Summary
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Constipated patients often have mental problems such as depression and anxiety due to difficult defecation. Our previous studies have proved the efficacy of FMT treating constipation. Meanwhile it is believed that mental diseases are correlated to gut microbiota. This trial is based on the theory of the gut-brain-microbiota axis. Patients with constipation, depression and/or anxiety are performed FMT, laboratory, imaging and microbiota examinations, and clinical follow-up, to observe the clinical efficiency of FMT and the potential role of gut microbiome in these gut-brain disorders.

Official Title
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FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms

Conditions
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Constipation - Functional, Depressive Symptoms, Anxiety Symptoms, Gut-Brain Disorders

Intervention / Treatment
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* Other: FMT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were diagnosed as functional constipation (FC) according to Rome Ⅳ criteria were enrolled. Age ≥ 18 years Body mass index of 18-25 kg/m2. HAMA ≥ 14 and/or HAMD (17 items) ≥ 17 Exclusion Criteria: History of sever mental disorders such as schizophrenia and bipolar disorder History of organic intestinal disorders History of gastrointestinal surgery Pregnant or breast-feeding women Infection with enteric pathogen Usage of probiotics, prebiotics, antibiotics within the last month Uncontrolled hepatic, renal, cardiovascular, and respiratory, or any diseases that in the opinion of the investigator, could affect intestinal transit and the intestinal microbiota. Patients who could not complete the follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FMT group<br> | Other: FMT<br>* fecal microbiota transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CSBMs per week | complete spontaneous bowl movements per week | 12 weeks after treatment | 
| HAMA | score of Hamilton Anxiety Rating Scale | 12 weeks after treatment | 
| HAMD | score of Hamilton Depression Rating Scale | 12 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wexner | score of Wexner | pre, 2 weeks, 4 weeks, 8 weeks, 12weeks | 
| PAC-SYM | score of PAC-SYM | pre, 2 weeks, 4 weeks, 8 weeks, 12weeks | 
| Bristol Bristol PAC-SYM | score of Bristol score of Bristol | pre, 2 weeks, 4 weeks, 8 weeks, 12weeks | 
| PAC-QOL | score of PAC-QOL | pre, 2 weeks, 4 weeks, 8 weeks, 12weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FMT, gut microbiota, gut-brain disorder, constipation, depression, anxiety