Efficacy and Safety of Fecal Microbiota Transplantation for Chronic Intestinal Pseudo-obstruction
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 2, 2016
CompletedFirst Posted
Study publicly available on registry
April 7, 2016
CompletedAugust 9, 2017
August 1, 2017
9 months
April 2, 2016
August 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
8 weeks
the time oral intake started
The time when oral intake (both fluids and solid food) started was noted.
8 weeks
Secondary Outcomes (2)
symptomatic relief
8 weeks
scoring evaluation of abdominal CT
8 weeks
Study Arms (1)
FMT
EXPERIMENTALPatients included will receive standard FMT, and then will be followed up for 8 weeks.
Interventions
Patients received frozen FMT on 6 consecutive days through nasojejunal tubes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- None.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210002, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ning Li, MD
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD candidate
Study Record Dates
First Submitted
April 2, 2016
First Posted
April 7, 2016
Study Start
December 1, 2014
Primary Completion
September 1, 2015
Study Completion
March 1, 2016
Last Updated
August 9, 2017
Record last verified: 2017-08