Back to resultsFMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms
Primary Purpose
Constipation - Functional, Depressive Symptoms, Anxiety Symptoms
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
FMT
Sponsored by
About this trial
This is an interventional treatment trial for Constipation - Functional focused on measuring FMT, gut microbiota, gut-brain disorder, constipation, depression, anxiety
Eligibility Criteria
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
Sites / Locations
- Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FMT group
Arm Description
Outcomes
Primary Outcome Measures
CSBMs per week
complete spontaneous bowl movements per week
HAMA
score of Hamilton Anxiety Rating Scale
HAMD
score of Hamilton Depression Rating Scale
Secondary Outcome Measures
Wexner
score of Wexner
PAC-SYM
score of PAC-SYM
Bristol Bristol PAC-SYM
score of Bristol score of Bristol
PAC-QOL
score of PAC-QOL
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03233100
Brief Title
FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms
Official Title
FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2017 (Anticipated)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jianfeng Gong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation - Functional, Depressive Symptoms, Anxiety Symptoms, Gut-Brain Disorders
Keywords
FMT, gut microbiota, gut-brain disorder, constipation, depression, anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FMT group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
FMT
Intervention Description
fecal microbiota transplantation
Primary Outcome Measure Information:
Title
CSBMs per week
Description
complete spontaneous bowl movements per week
Time Frame
12 weeks after treatment
Title
HAMA
Description
score of Hamilton Anxiety Rating Scale
Time Frame
12 weeks after treatment
Title
HAMD
Description
score of Hamilton Depression Rating Scale
Time Frame
12 weeks after treatment
Secondary Outcome Measure Information:
Title
Wexner
Description
score of Wexner
Time Frame
pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
Title
PAC-SYM
Description
score of PAC-SYM
Time Frame
pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
Title
Bristol Bristol PAC-SYM
Description
score of Bristol score of Bristol
Time Frame
pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
Title
PAC-QOL
Description
score of PAC-QOL
Time Frame
pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
Other Pre-specified Outcome Measures:
Title
Gut microbiota analysis
Description
Gut microbiota analysis
Time Frame
pre, 4 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianfeng Gong, MD
Phone
+86-25-80860036
Email
gongjianfeng@hotmail.com
Facility Information:
Facility Name
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianfeng Gong, MD
Phone
+86-25-80860036
Email
gongjianfeng@aliyun.com
12. IPD Sharing Statement
Learn more about this trial
FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms
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