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

NCT ID: NCT02731183

Last Updated: 2017-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-03-31

Brief Summary

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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

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Conditions

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Chronic Intestinal Pseudo Obstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FMT

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

Group Type EXPERIMENTAL

fecal microbiota transplantation

Intervention Type PROCEDURE

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

Interventions

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fecal microbiota transplantation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Ding Chao

MD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ning Li, MD

Role: STUDY_DIRECTOR

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Locations

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Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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FMT-CIPO

Identifier Type: -

Identifier Source: org_study_id

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