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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Jinling Hospital, China
Sponsor:
Information provided by (Responsible Party):
Ding Chao, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT02731183
First received: April 2, 2016
Last updated: August 29, 2016
Last verified: August 2016
  Purpose
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.

Condition Intervention Phase
Chronic Intestinal Pseudo Obstruction
Procedure: fecal microbiota transplantation
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fecal Microbiota Transplantation in Treatment of Chronic Intestinal Pseudo-obstruction: a Preliminary Study

Resource links provided by NLM:


Further study details as provided by Jinling Hospital, China:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 10
Study Start Date: September 2015
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FMT
Patients included will receive standard FMT, and then will be followed up for 8 weeks.
Procedure: fecal microbiota transplantation
Patients received frozen FMT on 6 consecutive days through nasojejunal tubes.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02731183

Contacts
Contact: Chao Ding, MD candidate +86-25-80860036 dingchao19910521@126.com
Contact: Ning Li, MD +86-25-80860089 jinlingh_lining@126.com

Locations
China, Jiangsu
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Chao Ding, MD candidate    +86-25-80860036    dingcaho199105121@126.com   
Contact: Ning Li, MD    +86-25-80860089    liningrigs@vip.sina.com   
Sponsors and Collaborators
Jinling Hospital, China
Investigators
Study Director: Ning Li, MD Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
  More Information

Responsible Party: Ding Chao, MD candidate, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02731183     History of Changes
Other Study ID Numbers: FMT-CIPO
Study First Received: April 2, 2016
Last Updated: August 29, 2016

Keywords provided by Jinling Hospital, China:
Fecal Microbiota Transplantation
Chronic intestinal pseudo obstruction
Efficacy and safety

Additional relevant MeSH terms:
Intestinal Pseudo-Obstruction
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on March 29, 2017