Fecal Microbiota Transplantation for Chronic Functional Constipation (FMTFCFC)

First Affiliated Hospital of Chengdu Medical College

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Intestinal Bacteria Flora Disturbance; Chronic Functional Constipation; Fecal Microbiota Transplantation

Treatments: Other: Normal Saline; Other: Fecal Microbiota Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03018613

FMT-CFC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

treatment for part 1

Active Comparator group

Description:

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

Treatment:

Other: Fecal Microbiota Transplantation

Placebo for part 2

Placebo Comparator group

Description:

The traditional treatments and normal saline will be used in patients with chronic functional constipation in part 2 according to associated guidelines.

Treatment:

Other: Normal Saline