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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03233100
Recruitment Status : Unknown
Verified July 2017 by Jianfeng Gong, Jinling Hospital, China.
Recruitment status was:  Recruiting
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Jianfeng Gong, Jinling Hospital, China

Tracking Information
First Submitted Date  ICMJE July 22, 2017
First Posted Date  ICMJE July 28, 2017
Last Update Posted Date July 28, 2017
Estimated Study Start Date  ICMJE July 30, 2017
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2017)
  • CSBMs per week [ Time Frame: 12 weeks after treatment ]
    complete spontaneous bowl movements per week
  • HAMA [ Time Frame: 12 weeks after treatment ]
    score of Hamilton Anxiety Rating Scale
  • HAMD [ Time Frame: 12 weeks after treatment ]
    score of Hamilton Depression Rating Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2017)
  • Wexner [ Time Frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks ]
    score of Wexner
  • PAC-SYM [ Time Frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks ]
    score of PAC-SYM
  • Bristol Bristol PAC-SYM [ Time Frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks ]
    score of Bristol score of Bristol
  • PAC-QOL [ Time Frame: pre, 2 weeks, 4 weeks, 8 weeks, 12weeks ]
    score of PAC-QOL
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 25, 2017)
Gut microbiota analysis [ Time Frame: pre, 4 weeks, 12 weeks ]
Gut microbiota analysis
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms
Official Title  ICMJE FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Constipation - Functional
  • Depressive Symptoms
  • Anxiety Symptoms
  • Gut-Brain Disorders
Intervention  ICMJE Other: FMT
fecal microbiota transplantation
Study Arms  ICMJE Experimental: FMT group
Intervention: Other: FMT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 25, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03233100
Other Study ID Numbers  ICMJE STC-D-A-2017-FMT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jianfeng Gong, Jinling Hospital, China
Study Sponsor  ICMJE Jianfeng Gong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jinling Hospital, China
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP