Fecal Microbiota Transplantation for Chronic Functional Constipation (FMTFCFC)
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|ClinicalTrials.gov Identifier: NCT03018613|
Recruitment Status : Unknown
Verified December 2016 by First Affiliated Hospital of Chengdu Medical College.
Recruitment status was: Recruiting
First Posted : January 12, 2017
Last Update Posted : January 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Functional Constipation Intestinal Bacteria Flora Disturbance Fecal Microbiota Transplantation||Other: Fecal Microbiota Transplantation Other: Normal Saline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Effect of Fecal Microbiota Transplantation on Chronic Functional Constipation and Its Mechanism|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2019|
Active Comparator: treatment for part 1
Fecal microbiota transplantation and traditional treatments will be used in patients with chronic functional constipation in part 1.
Other: Fecal Microbiota Transplantation
Fecal Microbiota Transplantation and the traditional treatments for chronic functional constipation in part 1.
Other Name: Fecal Microbiota Transplantation(FMT)
Placebo Comparator: 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.
Other: Normal Saline
Normal saline and the traditional treatments for chronic functional constipation in part 2
Other Name: Normal Saline(NS)
- Number of adverse events complication rate in all patients in both groups [ Time Frame: 3 months ]
- Mean number of bowel movements per week [ Time Frame: 4 weeks ]
- Bristol stool scale [ Time Frame: 4 weeks ]
- Constipation-related symptoms assessments [ Time Frame: 4 weeks ]Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4.
- Usage of laxatives or enemas as rescue medication [ Time Frame: 4 weeks ]
- Histological changes in the intestinal biopsy in both groups. [ Time Frame: 4 weeks ]
- Microbiota composition [ Time Frame: 4 weeks ]
- Nitric oxide(NO) [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018613
|Contact: Xiaoan Li, Ph.Dfirstname.lastname@example.org|
|IEC of Chengdu Medical College||Recruiting|
|Chendu, China, 610500|
|Contact: Xiaoan Li, Ph.D +8613680868858 email@example.com|
|Study Chair:||Xiaoan Li, Ph.D||First Affiliated Hospital of Chengdu Medical College|