Fecal Microbiota Transplantation for Chronic Functional Constipation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Functional Constipation Intestinal Bacteria Flora Disturbance Fecal Microbiota Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment for part 1

Fecal microbiota transplantation and traditional treatments will be used in patients with chronic functional constipation in part 1.

Group Type ACTIVE_COMPARATOR

Fecal Microbiota Transplantation

Intervention Type OTHER

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

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.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

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

Interventions

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Fecal Microbiota Transplantation

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

Intervention Type OTHER

Normal Saline

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

Intervention Type OTHER

Other Intervention Names

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Fecal Microbiota Transplantation(FMT) Normal Saline(NS)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes