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

Sponsor

Jianfeng Gong (Other)

Overall Status

Unknown status

CT.gov ID

NCT03233100

Collaborator

(none)

Enrollment

Location

Arm

17.1

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Constipation - Functional Depressive Symptoms Anxiety Symptoms Gut-Brain Disorders	Other: FMT	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 30, 2017

Anticipated Primary Completion Date :

Dec 31, 2018

Anticipated Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FMT group	Other: FMT fecal microbiota transplantation

Arm

Intervention/Treatment

Experimental: FMT group

Other: FMT

fecal microbiota transplantation

Outcome Measures

Primary Outcome Measures

CSBMs per week [12 weeks after treatment]
complete spontaneous bowl movements per week
HAMA [12 weeks after treatment]
score of Hamilton Anxiety Rating Scale
HAMD [12 weeks after treatment]
score of Hamilton Depression Rating Scale

Secondary Outcome Measures

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
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

Other Outcome Measures

Gut microbiota analysis [pre, 4 weeks, 12 weeks]
Gut microbiota analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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