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

July 25, 2017 updated by: Jianfeng Gong
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: FMT group
Other: FMT
fecal microbiota transplantation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gut microbiota analysis
Time Frame: pre, 4 weeks, 12 weeks
Gut microbiota analysis
pre, 4 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jianfeng Gong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 30, 2017

Primary Completion (ANTICIPATED)

December 31, 2018

Study Completion (ANTICIPATED)

December 31, 2018

Study Registration Dates

First Submitted

July 22, 2017

First Submitted That Met QC Criteria

July 25, 2017

First Posted (ACTUAL)

July 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STC-D-A-2017-FMT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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