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

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ClinicalTrials.gov Identifier: NCT03233100
Recruitment Status : Recruiting
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Jianfeng Gong, Jinling Hospital, China

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Estimated Study Start Date : July 30, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Constipation

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




Primary Outcome Measures :
  1. CSBMs per week [ Time Frame: 12 weeks after treatment ]
    complete spontaneous bowl movements per week

  2. HAMA [ Time Frame: 12 weeks after treatment ]
    score of Hamilton Anxiety Rating Scale

  3. HAMD [ Time Frame: 12 weeks after treatment ]
    score of Hamilton Depression Rating Scale


Secondary Outcome Measures :
  1. Wexner [ Time Frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks ]
    score of Wexner

  2. PAC-SYM [ Time Frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks ]
    score of PAC-SYM

  3. Bristol Bristol PAC-SYM [ Time Frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks ]
    score of Bristol score of Bristol

  4. PAC-QOL [ Time Frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks ]
    score of PAC-QOL


Other Outcome Measures:
  1. Gut microbiota analysis [ Time Frame: pre, 4 weeks, 12 weeks ]
    Gut microbiota analysis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233100


Contacts
Contact: Jianfeng Gong, MD +86-25-80860036 gongjianfeng@hotmail.com

Locations
China, Jiangsu
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Jianfeng Gong, MD    +86-25-80860036    gongjianfeng@aliyun.com   
Sponsors and Collaborators
Jianfeng Gong

Responsible Party: Jianfeng Gong, Professor, Associate senior doctor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT03233100     History of Changes
Other Study ID Numbers: STC-D-A-2017-FMT
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jianfeng Gong, Jinling Hospital, China:
FMT
gut microbiota
gut-brain disorder
constipation
depression
anxiety

Additional relevant MeSH terms:
Depression
Anxiety Disorders
Constipation
Brain Diseases
Behavioral Symptoms
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Central Nervous System Diseases
Nervous System Diseases