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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02731183
Recruitment Status : Completed
First Posted : April 7, 2016
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Ding Chao, Jinling Hospital, China

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.

Condition or disease Intervention/treatment Phase
Chronic Intestinal Pseudo Obstruction Procedure: fecal microbiota transplantation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Fecal Microbiota Transplantation in Treatment of Chronic Intestinal Pseudo-obstruction: a Preliminary Study
Actual Study Start Date : December 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : March 2016


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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.

  2. scoring evaluation of abdominal CT [ Time Frame: 8 weeks ]
    We use a computed tomography scoring system to evaluate the severity of obstruction.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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:

None.


Information from the National Library of Medicine

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): NCT02731183


Locations
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China, Jiangsu
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Jinling Hospital, China
Investigators
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Study Director: Ning Li, MD Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
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Responsible Party: Ding Chao, MD candidate, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02731183    
Other Study ID Numbers: FMT-CIPO
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Keywords provided by Ding Chao, Jinling Hospital, China:
Fecal Microbiota Transplantation
Chronic intestinal pseudo obstruction
Efficacy and safety
Additional relevant MeSH terms:
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Intestinal Pseudo-Obstruction
Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases