Fecal Microbiota Transplantation for Chronic Functional Constipation

Phase 1

• Conditions: Intestinal Bacteria Flora Disturbance; Chronic Functional Constipation; Fecal Microbiota Transplantation
• Interventions: Other: Fecal Microbiota Transplantation; Other: Normal Saline

• Registration Number: NCT03018613
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-07
• Status Verified: 2016-12
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-10
• Last Update Submitted: 2017-01-10
• Study First Posted: 2017-01-12
• Last Update Posted: 2017-01-12
• Primary Completion: 2018-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment for part 1	Fecal Microbiota Transplantation	Fecal microbiota transplantation and traditional treatments will be used in patients with chronic functional constipation in part 1.
Placebo for part 2	Normal Saline	The traditional treatments and normal saline will be used in patients with chronic functional constipation in part 2 according to associated guidelines.

Primary Outcome Measures

Name	Time	Method
Number of adverse events complication rate in all patients in both groups	3 months

Secondary Outcome Measures

Name	Time	Method
Microbiota composition	4 weeks
Nitric oxide(NO)	4 weeks
Mean number of bowel movements per week	4 weeks
Bristol stool scale	4 weeks
Constipation-related symptoms assessments	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	4 weeks
Histological changes in the intestinal biopsy in both groups.	4 weeks

Trial Locations

Locations (1)

IEC of Chengdu Medical College; 🇨🇳 Chendu, China