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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000429

Enrollment

100

Registered

2023-08-07

Start date

2023-09-05

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers

Interventions

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, fas

same appearance and application scheme as the Experimental product.

Probiotics

Dietary Supplements

Placebos

Bacillus clausii AO1125

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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=(0.32810Weight)+(0.33929height)-29.5336 For Women: MM=(0.29569weight)+(0.41813height)-43.2933 Measurement time: All the variables will be measured at the beginning, day 0; and at the end of the study, day 60.	—

Measure

Time frame

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.

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Countries

Cuba

Contacts

Public ContactGissel Garcia Menendez

Hermanos Ameijeiras Clinical Surgical Hospital

gisselgarcia@infomed.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026