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

J

Jianfeng Gong

Status

Unknown

Conditions

Depressive Symptoms
Anxiety Symptoms
Gut-Brain Disorders
Constipation - Functional

Treatments

Other: FMT

Study type

Interventional

Funder types

Other

Identifiers

NCT03233100
STC-D-A-2017-FMT

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

FMT group
Experimental group
Treatment:
Other: FMT

Trial contacts and locations

1

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Central trial contact

Jianfeng Gong, MD

Data sourced from clinicaltrials.gov

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