Efficacy and Safety of Fecal Microbiota Transplantation for Chronic Intestinal Pseudo-obstruction

• ClinicalTrials.gov Identifier: NCT02731183
• Recruitment Status: Completed
• First Posted: April 7, 2016
• Last Update Posted: August 9, 2017
• Sponsor: Jinling Hospital, China
• Information provided by (Responsible Party): Ding Chao, Jinling Hospital, China

Tracking Information

• First Submitted Date: April 2, 2016
• First Posted Date: April 7, 2016
• Last Update Posted Date: August 9, 2017
• Actual Study Start Date: December 2014
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 6, 2016)

• the tolerance of enteral nutrition (EN) through nasojejunal tube [ Time Frame: 8 weeks ]
  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 [ Time Frame: 8 weeks ]
  The time when oral intake (both fluids and solid food) started was noted.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 6, 2016)

• symptomatic relief [ Time Frame: 8 weeks ]
  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 [ Time Frame: 8 weeks ]
  We use a computed tomography scoring system to evaluate the severity of obstruction.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Intestinal Pseudo Obstruction

Intervention

Procedure: fecal microbiota transplantation

Patients received frozen FMT on 6 consecutive days through nasojejunal tubes.

Study Arms

Experimental: FMT

Patients included will receive standard FMT, and then will be followed up for 8 weeks.

Intervention: Procedure: fecal microbiota transplantation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 8, 2017): 9
• Original Estimated Enrollment (submitted: April 6, 2016): 10
• Actual Study Completion Date: March 2016
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02731183
• Other Study ID Numbers: FMT-CIPO
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Ding Chao, Jinling Hospital, China
• Study Sponsor: Jinling Hospital, China
• Collaborators: Not Provided

Investigators

• Study Director: Ning Li, MD; Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

• PRS Account: Jinling Hospital, China
• Verification Date: August 2017