Clinical trial NCT03018613: Fecal Microbiota Transplantation for Chronic Functional Constipation
Official title: Evaluation of the Effect of Fecal Microbiota Transplantation on Chronic Functional Constipation and Its Mechanism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronic Functional Constipation
Intestinal Bacteria Flora Disturbance
Fecal Microbiota Transplantation
Keywords: Chronic Functional Constipation
Intestinal Bacteria Flora Disturbance
Fecal Microbiota Transplantation
Lead sponsor: First Affiliated Hospital of Chengdu Medical College
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of adverse events complication rate in all patients in both groups
timeFrame: 3 months
Secondary outcomes:
measure: Mean number of bowel movements per week
timeFrame: 4 weeks
measure: Bristol stool scale
timeFrame: 4 weeks
measure: Constipation-related symptoms assessments
timeFrame: 4 weeks
measure: Usage of laxatives or enemas as rescue medication
timeFrame: 4 weeks
measure: Histological changes in the intestinal biopsy in both groups.
timeFrame: 4 weeks
measure: Microbiota composition
timeFrame: 4 weeks
measure: Nitric oxide(NO)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chendu
country: China
facility: IEC of Chengdu Medical College
Study officials:
affiliation: First Affiliated Hospital of Chengdu Medical College
name: Xiaoan Li, Ph.D
role: STUDY_CHAIR
References: