Evaluation of a Probiotic on LDL-cholesterol Levels | NCT04029818

Studies
Evaluation of a Probiotic on LDL-cholesterol Levels

NCT04029818

Sponsor

Biosearch S.A.

Status

Completed

Last Update Posted

Nov 15, 2019Actual

Enrollment

40Actual

Phase

Phase 1

Conditions

Cardiovascular Diseases
LDL-cholesterol

Interventions

Bifidobacterium BSL_PS404
Placebo

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 24, 2019Actual

Primary Completion Date

Jul 31, 2019Actual

Completion Date

Jul 31, 2019Actual

First Submitted Date

Jul 22, 2019

First Submission Date that Met QC Criteria

Jul 22, 2019

First Posted Date

Jul 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2019

Last Update Posted Date

Nov 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the present study is to evaluate the ability of Bifidobacterium BSL_PS404 in reducing LDL-cholesterol levels in healthy individuals.

Detailed Description

There is a strong correlation between LDL-cholesterol and cardiovascular diseases.

Conjugated bile acids help to break down and emulsify dietary fat into micelles that promote their absorption by the enterocytes. The disruption or alteration of these micelles may interfere with the absorption of cholesterol.

Several intestinal bacteria strains are capable of carrying out numerous biotransformations of bile salts during their enterohepatic circulation, such as the hydrolysis of the conjugated bile acids by the action of hydrolases. The mechanism proposed to explain the cholesterol-lowering activity of these probiotic strains is that, due to the greater bile salt hydroxylation in the intestine, the formation of micelles would decrease and, therefore, the absorption of cholesterol and lipids would be decrease too. In addition, probiotics may also increase the excretion of bile acids in the stool, possibly by binding or absorbing them. This increase in fecal secretion of bile acids would require an increase in the hepatic catabolism of cholesterol for the synthesis of bile acids. All these processes may help to reduce LDL-cholesterol levels Bifidobacterium BSL_PS404 is a bacterium isolated from maternal milk with QPS category that presents a high hydrolase activity that exceeds in more than 20% the activity of other reference strains.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic	Experimental	Volunteers will take a capsule with Bifidobacterium BSL_PS404 (3x109 cfu) daily.	Biological: Bifidobacterium BSL_PS404
Placebo	Placebo Comparator	Volunteers will take a capsule with maltodextrin daily.	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bifidobacterium BSL_PS404	Biological	Each participant will consume 1 capsule daily at lunch for 8 weeks.	Probiotic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
LDL-cholesterol	Levels of LDL-cholesterol in plasma	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Total cholesterol	Levels of total cholesterol in plasma	8 weeks
HDL-cholesterol	Levels of HDL-cholesterol in plasma	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Levels of LDL-cholesterol between 100 and 190 mg/dL.
Accept freely to participate in the study and sign the informed consent document.

Exclusion Criteria:

Be pregnant.
Have planned to carry out a dietary intervention or exercise practice with the aim of losing weight in the coming weeks.
Having a serious illness.
Having diabetes.
Having a cerebrovascular disease.
Being allergic to any group of antibiotics.
Take probiotics in the form of supplements at least 4 weeks before.
Take antibiotics at least 4 weeks before.
Being taking products or drugs to control cholesterol levels

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Miguel Quesada, MD, PhD	Medical specialist in Endocrinology, Hospital San Cecilio de Granada	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital San Cecilio		Granada	Andalusia	18016	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided