Fecal Microbiota Transplantation for Chronic Functional C... | NCT03018613

Studies
Fecal Microbiota Transplantation for Chronic Functional Constipation

NCT03018613

Sponsor

First Affiliated Hospital of Chengdu Medical College

Status

Unknown status

Last Update Posted

Jan 12, 2017Estimated

Enrollment

60Estimated

Phase

Phase 1Phase 2

Conditions

Chronic Functional Constipation
Intestinal Bacteria Flora Disturbance
Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation
Normal Saline

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Jul 2018Estimated

Completion Date

Jul 2019Estimated

First Submitted Date

Jan 3, 2017

First Submission Date that Met QC Criteria

Jan 10, 2017

First Posted Date

Jan 12, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2017

Last Update Posted Date

Jan 12, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
treatment for part 1	Active Comparator	Fecal microbiota transplantation and traditional treatments will be used in patients with chronic functional constipation in part 1.	Other: Fecal Microbiota Transplantation
Placebo for part 2	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fecal Microbiota Transplantation	Other	Fecal Microbiota Transplantation and the traditional treatments for chronic functional constipation in part 1.	treatment for part 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of adverse events complication rate in all patients in both groups		3 months

Secondary Outcomes

Measure	Description	Time Frame
Mean number of bowel movements per week		4 weeks
Bristol stool scale		4 weeks
Constipation-related symptoms assessments

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

subjects voluntarily participate in the trial and sign informed consent;
sex is not limited,ranging from 18 to 75 years old;
meet the diagnostic criteria for chronic functional constipation in patients;
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;
be able to communicate well with the researchers and follow the verification requirements.

Exclusion criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaoan Li, Ph.D	Contact	+8613880868858		zqzy1983@163.com

Overall Officials

Name	Affiliation	Role
Xiaoan Li, Ph.D	First Affiliated Hospital of Chengdu Medical College	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IEC of Chengdu Medical College	Recruiting	Chendu		610500	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069467	Fecal Microbiota Transplantation
D000077330	Saline Solution

Ancestor Terms

ID	Term
D001691	Biological Therapy
D013812	Therapeutics
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions

Browse Leaves

Not provided

Browse Branches

Not provided