Efficacy and Safety of Fecal Microbiota Transplantation for Chronic Intestinal Pseudo-obstruction
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|ClinicalTrials.gov Identifier: NCT02731183|
Recruitment Status : Completed
First Posted : April 7, 2016
Last Update Posted : August 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Intestinal Pseudo Obstruction||Procedure: fecal microbiota transplantation||Not Applicable|
|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|
|Actual Primary Completion Date :||September 2015|
|Actual 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.
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
|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|