Anxiety Symptoms, Constipation - Functional, Depressive Symptoms, Gut-Brain Disorders
Conditions
Keywords
FMT, gut microbiota, gut-brain disorder, constipation, depression, anxiety
Brief summary
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.
Interventions
OTHERFMT
fecal microbiota transplantation
Sponsors
Jianfeng Gong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HAMD | 12 weeks after treatment | score of Hamilton Depression Rating Scale |
| CSBMs per week | 12 weeks after treatment | complete spontaneous bowl movements per week |
| HAMA | 12 weeks after treatment | score of Hamilton Anxiety Rating Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bristol Bristol PAC-SYM | pre, 2 weeks, 4 weeks, 8 weeks, 12weeks | score of Bristol score of Bristol |
| PAC-QOL | pre, 2 weeks, 4 weeks, 8 weeks, 12weeks | score of PAC-QOL |
| Wexner | pre, 2 weeks, 4 weeks, 8 weeks, 12weeks | score of Wexner |
| PAC-SYM | pre, 2 weeks, 4 weeks, 8 weeks, 12weeks | score of PAC-SYM |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiota analysis | pre, 4 weeks, 12 weeks | Gut microbiota analysis |
Countries
China
Contacts
Primary ContactJianfeng Gong, MD
Outcome results
None listed