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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-30

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Constipation - Functional Depressive Symptoms Anxiety Symptoms Gut-Brain Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FMT group

Group Type EXPERIMENTAL

FMT

Intervention Type OTHER

fecal microbiota transplantation

Interventions

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FMT

fecal microbiota transplantation

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes