Safety evaluation of Bacillus clausii AO1125 for its use as a probiotic in humans

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Safety evaluation of Bacillus clausii AO1125 for its use as a probiotic in humans”.

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Biocollective Company, Denver Colorado USA

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Gissel

Last name:

García Menéndez

Medical Specialty :

Graduate in Biochemistry, Master in Virology, PhD in Sciences

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal address:

San Lazaro 701 corner to Belascoain

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-78761632

Email address:

gisselgarcia@infomed.sld.cu

gisselgarcia2805@gmail.com

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

05/09/2023

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

healthy volunteers

Health condition(s) code:

Healthy Volunteers

Healthy Aging

Intervention(s):

Group I (Experimental) One capsule of Bacillus clausii AO1125 (2.5 x109 bacteria / capsule mixed with the following excipients: calcium phosphate, magnesium stearate and colloidal silica), orally, fasting for 2 months . Group II (Control). Placebo; same appearance and application scheme as the Experimental product.

Intervention code:

Probiotics

Dietary Supplements

Placebos

Intervention keyword:

Bacillus clausii AO1125

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1.- Adverse effect. It will be measured taking into account: the presence of the adverse effect: (It does not appear to be an adverse effect, Possible adverse effect, Similar to an adverse effect, Adverse effect). Measurement time: at the end of the study, day 60. 2.- Intensity of the Adverse Effect. (Mild (Does not produce restrictions in daily activities), Moderate (Produces a partial restriction of daily activities), Severe (Inability to carry out daily activities)). Measurement time: at the end of the study, day 60.

Key secondary outcomes:

Hematological variables, clinical chemistry, hemodynamic parameters and calculation of muscle mass Clinical Chemistry: -Liver enzymes (UKAT/L) -creatinine (umolL/L) -Urea (mmol/L) Hematological parameters Blood glucose (mmol/L), Leukocytes (x 109/L) Red blood cells (x 1012/L) Hemoglobin (g/dL) Hematocrit (%) MCV (fL) MCHC (g/dL) RDW (%) platelets (x 109/L) MPV (fL) Neutrophils (%) Lymphocytes (%) Monocytes (%) Eosinophils (%) Basophils (%) Neutrophils (x 109/L) Lymphocytes (x 109/L) Monocytes (x 109/L) Eosinpophils (x 109/L) Basophils (x 109/L) Hemodynamic Parameters Systolic blood pressure (mmHg). Diastolic blood pressure (mmHg) Heart rate (bpm) Calculation of muscle mass Muscle mass (MM) will be calculated for men and women using the following formulas using height and weight. For Men: MM=(0.32810*Weight)+(0.33929*height)-29.5336 For Women: MM=(0.29569*weight)+(0.41813*height)-43.2933 Measurement time: All the variables will be measured at the beginning, day 0; and at the end of the study, day 60.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

none

Inclusion criteria:

1.- Healthy individuals, over 18 years of age and will have no distinction of sex or skin color. 2.- They give their consent to participate in the study. 3.- Individuals who have hematological, clinical chemistry and hemodynamic parameters in normal ranges

Exclusion criteria:

Individuals suffering from any comorbidity. and who show alterations in their hematological, clinical or hemodynamic parameters.

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Other

Other purpose:

This is a study that will evaluate the probiotic strain Bacillus clausii AO1125 in healthy individuals, which has anti-inflammatory properties, so its use will have an impact on intestinal health as well as on improving the immunity of individuals.

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

1

Target sample size:

100

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Gissel

Last Name:

Garcia Menendez

Specialty:

Graduate in Biochemistry, Master in Virology, PhD in Sciences

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal Address:

San Lazaro 701 corner to Belascoain

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-78761632

Email :

gisselgarcia@infomed.sld.cu

gisselgarcia2805@gmail.com

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Gissel

Last Name:

Garcia Menendez

Specialty:

Graduate in Biochemistry, Master in Virology, PhD in Sciences

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal Address:

San Lazaro 701 corner to Belascoain

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-78761632

Email :

gisselgarcia@infomed.sld.cu

gisselgarcia2805@gmail.com

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Hermanos Ameijieras Clinical Surgery Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

15/02/2023

Postal address of Ethic Committee :

San Lazaro 701 corner to Belascoain, Havana, ZC 10300, Cuba

Telephone:

+53-78761000

Email:

hha@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

10/01/2024

Date of available results:

13/01/2025

Date of first publication:

17/03/2025

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000429

Date of Registration in Primary Registry:

07/08/2023

Record Verification Date:

2023/08/07

Next update date:

2024/08/07

Link to the spanish version:

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Safety evaluation of Bacillus clausii AO1125 for its use as a probiotic in humans

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