Clinical Trial: Fecal Microbiota Transplantation for Chronic Functional Constipation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluation of the Effect of Fecal Microbiota Transplantation on Chronic Functional Constipation and Its Mechanism

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.

Detailed Summary: 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.
Sponsor: First Affiliated Hospital of Chengdu Medical College

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mean number of bowel movements per week [ Time Frame: 4 weeks ]
  • Bristol stool scale [ Time Frame: 4 weeks ]
  • 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.
  • Usage of laxatives or enemas as rescue medication [ Time Frame: 4 weeks ]
  • Histological changes in the intestinal biopsy in both groups. [ Time Frame: 4 weeks ]
  • Microbiota composition [ Time Frame: 4 weeks ]
  • Nitric oxide(NO) [ Time Frame: 4 weeks ]


Original Secondary Outcome: Same as current

Information By: First Affiliated Hospital of Chengdu Medical College

Dates:
Date Received: January 3, 2017
Date Started: July 2016
Date Completion: July 2019
Last Updated: January 10, 2017
Last Verified: December 2016