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

Not Applicable

Completed

• Conditions: Chronic Intestinal Pseudo Obstruction
• Interventions: Procedure: fecal microbiota transplantation

• Registration Number: NCT02731183
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-09
• Study Completion: 2016-03
• Study First Submitted: 2016-04-02
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FMT	fecal microbiota transplantation	Patients included will receive standard FMT, and then will be followed up for 8 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
symptomatic relief	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	8 weeks	We use a computed tomography scoring system to evaluate the severity of obstruction.

Trial Locations

Locations (1)

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China