FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2017
CompletedFirst Posted
Study publicly available on registry
July 28, 2017
CompletedStudy Start
First participant enrolled
July 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJuly 28, 2017
July 1, 2017
1.4 years
July 22, 2017
July 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
Wexner
pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
PAC-SYM
pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
Bristol Bristol PAC-SYM
pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
PAC-QOL
pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
Other Outcomes (1)
Gut microbiota analysis
pre, 4 weeks, 12 weeks
Study Arms (1)
FMT group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jianfeng Gonglead
Study Sites (1)
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, Associate senior doctor
Study Record Dates
First Submitted
July 22, 2017
First Posted
July 28, 2017
Study Start
July 30, 2017
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
July 28, 2017
Record last verified: 2017-07