Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 7:18 AM
Study NCT ID:
NCT02972567
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2016-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effects of a L.Reuteri Strain on Markers of Inflammation, Cardiovascular Risk and Fatty Liver Disease
Sponsor:
Biosearch S.A.
Organization:
Study Overview
Official Title:
Evaluation of the Effect of a Lactobacillus Reuteri Strain on Markers of Inflammation, Cardiovascular Risk and Fatty Liver Disease in Obese Subjects With Insulin Resistance
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSIR
Brief Summary:
The purpose of this study is the evaluation of the effects in obese patients with metabolic syndrome on the composition of the intestinal microbiota, markers of the syndrome (hypertension, dyslipidemia, inflammation biomarkers, risk cardiovascular and hepatic steatosis) and other possible metabolites involved.
Detailed Description:
Randomized double blind crossover placebo controlled intervention study
The proposed study will be conducted by members of the Endocrinology and Nutrition Services (ENCHJ), and Gastroenterology (ADCHJ), of the Hospital of Jaen and members of the Department of Biochemistry and Molecular Biology II of the University of Granada (UGR) and members of Microbiology Department of the University Hospital San Cecilio of Granada (MHUSC).
The selection, clinical and anthropometric control, general biochemical parameters and the determination of hepatic steatosis by ultrasound will be performed by members of ENCHJ.
The determination of the composition of the intestinal microbiota will be carried out by members of the UGR together with members form the MHUSC. Inflammation and steatosis biomarkers as well as metabolic profile will be performed by members of the UGR.
The study will be conducted according to the Helsinki Rules and will be previously approved by the Ethics Committee of Research of Jaen. The study will follow the rules of international, national and regional research The biological samples will be managed and processed in accordance with the research protocols by the Biobanco del Sistema Sanitario Público de Andalucía. At the end of the project, samples will be stored within the framework of Biobank from Public Health Organization of Andalusia .
The present study involves access and use of information confidential, so all the data will be treated anonymously.
• Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
Based on the range and median value on plasma lipopolysaccharide (LPS), and assuming a power of 90% and a type error alpha of 5%, the minimum number of subjects was 32. To avoid possible bias caused by gender and taking into account the withdrawal, will be recruited 60 subjects.
The missing data will be considered as unavailable data.
All statistical analyses will be performed using the statistical package SPSS (Statistical Product and Service Solutions). Normally distributed data will be expressed as the mean and standard error of the mean, whereas median and ranges will be used for data not normally distributed.
The proposed study will be conducted by members of the Endocrinology and Nutrition Services (ENCHJ), and Gastroenterology (ADCHJ), of the Hospital of Jaen and members of the Department of Biochemistry and Molecular Biology II of the University of Granada (UGR) and members of Microbiology Department of the University Hospital San Cecilio of Granada (MHUSC).
The selection, clinical and anthropometric control, general biochemical parameters and the determination of hepatic steatosis by ultrasound will be performed by members of ENCHJ.
The determination of the composition of the intestinal microbiota will be carried out by members of the UGR together with members form the MHUSC. Inflammation and steatosis biomarkers as well as metabolic profile will be performed by members of the UGR.
The study will be conducted according to the Helsinki Rules and will be previously approved by the Ethics Committee of Research of Jaen. The study will follow the rules of international, national and regional research The biological samples will be managed and processed in accordance with the research protocols by the Biobanco del Sistema Sanitario Público de Andalucía. At the end of the project, samples will be stored within the framework of Biobank from Public Health Organization of Andalusia .
The present study involves access and use of information confidential, so all the data will be treated anonymously.
• Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
Based on the range and median value on plasma lipopolysaccharide (LPS), and assuming a power of 90% and a type error alpha of 5%, the minimum number of subjects was 32. To avoid possible bias caused by gender and taking into account the withdrawal, will be recruited 60 subjects.
The missing data will be considered as unavailable data.
All statistical analyses will be performed using the statistical package SPSS (Statistical Product and Service Solutions). Normally distributed data will be expressed as the mean and standard error of the mean, whereas median and ranges will be used for data not normally distributed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: