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
|Condition or disease||Intervention/treatment|
|Chronic Intestinal Pseudo Obstruction||Procedure: fecal microbiota transplantation|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Primary Completion Date :||September 2015|
|Study Completion Date :||March 2016|
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731183
|Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University|
|Nanjing, Jiangsu, China, 210002|
|Study Director:||Ning Li, MD||Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University|