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Fecal Microbiota Transplantation for Chronic Functional Constipation (FMTFCFC)

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ClinicalTrials.gov Identifier: NCT03018613
Recruitment Status : Unknown
Verified December 2016 by First Affiliated Hospital of Chengdu Medical College.
Recruitment status was:  Recruiting
First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Chengdu Medical College

Brief Summary:
Chronic functional constipation is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of chronic functional constipation is closely related to imbalance of intestinal flora .Moreover,types and quantity of intestinal flora may be related to intestinal motility. Fecal microbiota transplantation as a new technology to rebuild intestinal flora has been used for several disease,but the clinical efficacy of chronic functional constipation by fecal microbiota transplantation needs to be further explored.

Condition or disease Intervention/treatment Phase
Chronic Functional Constipation Intestinal Bacteria Flora Disturbance Fecal Microbiota Transplantation Other: Fecal Microbiota Transplantation Other: Normal Saline Phase 1 Phase 2

Detailed Description:
Patients who meet the inclusion crit chronic functional constipation will be separated into two parts depending on acceptation or refuse of Fecal microbiota transplantation.Blood specimen from patients will be collected to analysis intestinal motility.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of Fecal Microbiota Transplantation on Chronic Functional Constipation and Its Mechanism
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: treatment for part 1
Fecal microbiota transplantation and traditional treatments will be used in patients with chronic functional constipation in part 1.
Other: Fecal Microbiota Transplantation
Fecal Microbiota Transplantation and the traditional treatments for chronic functional constipation in part 1.
Other Name: Fecal Microbiota Transplantation(FMT)

Placebo Comparator: Placebo for part 2
The traditional treatments and normal saline will be used in patients with chronic functional constipation in part 2 according to associated guidelines.
Other: Normal Saline
Normal saline and the traditional treatments for chronic functional constipation in part 2
Other Name: Normal Saline(NS)




Primary Outcome Measures :
  1. Number of adverse events complication rate in all patients in both groups [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Mean number of bowel movements per week [ Time Frame: 4 weeks ]
  2. Bristol stool scale [ Time Frame: 4 weeks ]
  3. Constipation-related symptoms assessments [ Time Frame: 4 weeks ]
    Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4.

  4. Usage of laxatives or enemas as rescue medication [ Time Frame: 4 weeks ]
  5. Histological changes in the intestinal biopsy in both groups. [ Time Frame: 4 weeks ]
  6. Microbiota composition [ Time Frame: 4 weeks ]
  7. Nitric oxide(NO) [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. subjects voluntarily participate in the trial and sign informed consent;
  2. sex is not limited,ranging from 18 to 75 years old;
  3. meet the diagnostic criteria for chronic functional constipation in patients;
  4. patients has been ruled out organic diseases of the large intestine within 1 year by colonoscopy or barium enema examination, and stool routine and occult blood examination are normal within 1 month;
  5. be able to communicate well with the researchers and follow the verification requirements.

Exclusion criteria:

  1. does not meet the diagnostic criteria;
  2. with severe primary heart, liver, lung, kidney, blood or affect the survival of serious diseases;
  3. severe anemia and severe systemic infection;
  4. suspected or indeed have alcohol, drug abuse history;
  5. pregnancy or are preparing for pregnancy, and breastfeeding women;
  6. Those who are unwilling to accept the research measures or other reasons can not cooperate;
  7. due to mental disorders can not give adequate informed consent;
  8. Participated in other clinical trials within 3 months before the start of the study;
  9. researchers believe that participates are not suitable for other reasons in this clinical trial.

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): NCT03018613


Contacts
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Contact: Xiaoan Li, Ph.D +8613880868858 zqzy1983@163.com

Locations
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China
IEC of Chengdu Medical College Recruiting
Chendu, China, 610500
Contact: Xiaoan Li, Ph.D    +8613680868858    zqzy1983@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Chengdu Medical College
Investigators
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Study Chair: Xiaoan Li, Ph.D First Affiliated Hospital of Chengdu Medical College

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Responsible Party: First Affiliated Hospital of Chengdu Medical College
ClinicalTrials.gov Identifier: NCT03018613     History of Changes
Other Study ID Numbers: FMT-CFC
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by First Affiliated Hospital of Chengdu Medical College:
Chronic Functional Constipation
Intestinal Bacteria Flora Disturbance
Fecal Microbiota Transplantation
Additional relevant MeSH terms:
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Constipation
Dysbiosis
Signs and Symptoms, Digestive
Signs and Symptoms
Pathologic Processes