NCT03018613

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

January 12, 2017

Status Verified

December 1, 2016

Enrollment Period

2 years

First QC Date

January 3, 2017

Last Update Submit

January 10, 2017

Conditions

Chronic Functional ConstipationIntestinal Bacteria Flora DisturbanceFecal Microbiota Transplantation

Keywords

Chronic Functional ConstipationIntestinal Bacteria Flora DisturbanceFecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

  • Number of adverse events complication rate in all patients in both groups

    3 months

Secondary Outcomes (7)

  • Mean number of bowel movements per week

    4 weeks

  • Bristol stool scale

    4 weeks

  • Constipation-related symptoms assessments

    4 weeks

  • Usage of laxatives or enemas as rescue medication

    4 weeks

  • Histological changes in the intestinal biopsy in both groups.

    4 weeks

  • +2 more secondary outcomes

Study Arms (2)

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

Fecal Microbiota TransplantationOTHER

Fecal Microbiota Transplantation and the traditional treatments for chronic functional constipation in part 1.

Also known as: Fecal Microbiota Transplantation(FMT)
treatment for part 1
Normal SalineOTHER

Normal saline and the traditional treatments for chronic functional constipation in part 2

Also known as: Normal Saline(NS)
Placebo for part 2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IEC of Chengdu Medical College

Chendu, 610500, China

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota TransplantationSaline Solution

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeuticsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Xiaoan Li, Ph.D

    First Affiliated Hospital of Chengdu Medical College

    STUDY CHAIR

Central Study Contacts

Xiaoan Li, Ph.D

CONTACT

+8613880868858zqzy1983@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 12, 2017

Study Start

July 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2019

Last Updated

January 12, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)