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

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03233100
• Other study ID #: STC-D-A-2017-FMT
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2017
• Last updated: July 25, 2017
• Start date: July 30, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2017
• Source: Jinling Hospital, China
• Contact: Jianfeng Gong, MD
• Phone: +86-25-80860036
• Email: gongjianfeng[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who were diagnosed as functional constipation (FC) according to Rome ? 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

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety Symptoms
• Brain Diseases
• Constipation
• Constipation - Functional
• Depression
• Depressive Symptoms
• Gut-Brain Disorders

Intervention

Other:
• FMT
fecal microbiota transplantation

Locations

Country	Name	City	State
China	Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jianfeng Gong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gut microbiota analysis	Gut microbiota analysis	pre, 4 weeks, 12 weeks
Primary	CSBMs per week	complete spontaneous bowl movements per week	12 weeks after treatment
Primary	HAMA	score of Hamilton Anxiety Rating Scale	12 weeks after treatment
Primary	HAMD	score of Hamilton Depression Rating Scale	12 weeks after treatment
Secondary	Wexner	score of Wexner	pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
Secondary	PAC-SYM	score of PAC-SYM	pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
Secondary	Bristol Bristol PAC-SYM	score of Bristol score of Bristol	pre, 2 weeks, 4 weeks, 8 weeks, 12weeks
Secondary	PAC-QOL	score of PAC-QOL	pre, 2 weeks, 4 weeks, 8 weeks, 12weeks