Dietzia safety study

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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 Dietzia psychralcaliphila C79793-74 for its use as a probiotic in humans

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not aplicable

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:

Garcia Menendez

Medical Specialty :

PhD in Sciences, Graduate in Biochemistry, Master in Virology

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal address:

San Lazaro 701 corner Belascoain. Havana Center

City:

Havana

Country:

Cuba

Zip Code:

10300

Telephone:

+53-78761632

+53-52706385

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:

24/04/2023

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

Intervention(s):

Group I (Experimental) One capsule of Dietzia ssp. C79793–74 (2.5 x109 bacteria /capsule) mixed with the following excipients: dicalcium phosphate, magnesium stearate and colloidal silica). Oral administration, fasting (40 minutes before breakfast) daily for 2 months. Group II (Control) Placebo; same appearance and application scheme as the product

Intervention code:

Probiotics

Dietary Supplements

Placebos

Intervention keyword:

Dietzia ssp.

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):

Adverse effect (Name of the adverse effect, Does not appear to be an adverse effect, Possible adverse effect, Similar to an adverse effect). Measurement time: After 60 days. Intensity of the adverse effect (Mild, Moderate, Severe). Measurement time: After 60 days.

Key secondary outcomes:

Hematological variables, clinical chemistry, hemodynamic parameters and calculation of muscle mass. Measurement time: All will be measured at the beginning of the study (day 0) and at the end of the study (day 60). Clinical Chemistry: (-Liver enzymes (UKAT/L), -Creatinine (umolL/L), -Urea (mmol/L)) Hematological Parameters: (Blood glucose (mmol/L), Leukocytes (x 109/L), Erythrocytes (x 1012/L), Hemoglobin (g/dL), Ematocrit (%), 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: For Men: MM=(0.32810*Weight)+(0.33929*height)-29.5336 For Women: MM=(0.29569*weight)+(0.41813*height)-43.2933

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:

80 years

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 with a family history of inflammatory bowel disease. 4.- 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 Dietzia ssp. C79793–74 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:

50

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:

PhD in Sciences, Graduate in Biochemistry, Master in Virology

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal Address:

San Lazaro 701 corner Belascoain. Havana Center

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:

García Menéndez

Specialty:

PhD in Sciences, Graduate in Biochemistry, Master in Virology

Affiliation:

Hermanos Ameijeiras Clinical Surgical Hospital

Postal Address:

San Lazaro 701 corner Belascoain. Havana Center

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 Belascoain, Havana, ZC 10400, 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:

24/07/2023

Date of available results:

18/12/2023

Date of first publication:

05/02/2024

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:

RPCEC00000421

Date of Registration in Primary Registry:

17/04/2023

Record Verification Date:

2023/04/17

Next update date:

2024/04/17

Link to the spanish version:

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Dietzia safety study

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