Back to resultsEfficacy and Safety of Fecal Microbiota Transplantation for Chronic Intestinal Pseudo-obstruction
Primary Purpose
Chronic Intestinal Pseudo Obstruction
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
fecal microbiota transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Intestinal Pseudo Obstruction focused on measuring Fecal Microbiota Transplantation, Chronic intestinal pseudo obstruction, Efficacy and safety
Eligibility Criteria
Inclusion Criteria:
Patients had to have a firm diagnosis diagnostic criteria for CIPO proposed by Ministry of Health, Labour, and Welfare, including documented pathological bowel dilatation on imaging in the absence of mechanical obstruction.
Exclusion Criteria:
None.
Sites / Locations
- Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FMT
Arm Description
Patients included will receive standard FMT, and then will be followed up for 8 weeks.
Outcomes
Primary Outcome Measures
the tolerance of enteral nutrition (EN) through nasojejunal tube
We defined feeding intolerance (FI) as inability to deliver the amount of nutrient as a proportion of 'energy requirements', with values of 80% chosen, or a certain amount (750ml) per 24h.
the time oral intake started
The time when oral intake (both fluids and solid food) started was noted.
Secondary Outcome Measures
symptomatic relief
The occurrence and severity of each of these symptoms: pain, nausea, vomiting and bloating (each scored as 0 = absent, 1 = mild, 2 = medium, 3 = severe, or 4 = could not be worse) were recorded by nurses blinded to the intervention on a daily basis.
scoring evaluation of abdominal CT
We use a computed tomography scoring system to evaluate the severity of obstruction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02731183
Brief Title
Efficacy and Safety of Fecal Microbiota Transplantation for Chronic Intestinal Pseudo-obstruction
Official Title
Efficacy and Safety of Fecal Microbiota Transplantation in Treatment of Chronic Intestinal Pseudo-obstruction: a Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic intestinal pseudo obstruction(CIPO) is a serious motility disorder with life-threatening condition, and it is often related with bacterial overgrowth. Fecal microbiota transplantation (FMT) results in restoration of the normal intestinal microbial community structure. The investigators planned to observe the efficacy of FMT in the treatment of a series CIPO patients. Patients received FMT on 6 consecutive days through nasojejunal tubes and followed up for 8 weeks after treatment. Rate of clinical improvement and remission, feeding tolerance of enteral nutrition, CT score of intestinal obstruction, and gastrointestinal quality-of-life index(GIQLI) were evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Intestinal Pseudo Obstruction
Keywords
Fecal Microbiota Transplantation, Chronic intestinal pseudo obstruction, Efficacy and safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FMT
Arm Type
Experimental
Arm Description
Patients included will receive standard FMT, and then will be followed up for 8 weeks.
Intervention Type
Procedure
Intervention Name(s)
fecal microbiota transplantation
Intervention Description
Patients received frozen FMT on 6 consecutive days through nasojejunal tubes.
Primary Outcome Measure Information:
Title
the tolerance of enteral nutrition (EN) through nasojejunal tube
Description
We defined feeding intolerance (FI) as inability to deliver the amount of nutrient as a proportion of 'energy requirements', with values of 80% chosen, or a certain amount (750ml) per 24h.
Time Frame
8 weeks
Title
the time oral intake started
Description
The time when oral intake (both fluids and solid food) started was noted.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
symptomatic relief
Description
The occurrence and severity of each of these symptoms: pain, nausea, vomiting and bloating (each scored as 0 = absent, 1 = mild, 2 = medium, 3 = severe, or 4 = could not be worse) were recorded by nurses blinded to the intervention on a daily basis.
Time Frame
8 weeks
Title
scoring evaluation of abdominal CT
Description
We use a computed tomography scoring system to evaluate the severity of obstruction.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients had to have a firm diagnosis diagnostic criteria for CIPO proposed by Ministry of Health, Labour, and Welfare, including documented pathological bowel dilatation on imaging in the absence of mechanical obstruction.
Exclusion Criteria:
None.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ning Li, MD
Organizational Affiliation
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Fecal Microbiota Transplantation for Chronic Intestinal Pseudo-obstruction
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