Dietzia safety study

Safety evaluation of Dietzia natronolimnaea C79793-74 for its use as a probiotic in humans

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000421

Enrollment

Registered

2023-04-17

Start date

2023-04-24

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 Dietzia ssp. C79793–74 (2.5 x109 bacteria /capsule) mixed with the following excipients: dicalcium phosphate, magnesium stearate and colloidal silica). Oral admin

same appearance and application scheme as the product

Probiotics

Dietary Supplements

Placebos

Dietzia ssp.

Eligibility

Sex/Gender

All

Age

19 Years to 80 Years

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 with a family history of inflammatory bowel disease. 4.- 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
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.	—

Secondary

Measure	Time frame
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=(0.32810Weight)+(0.33929height)-29.5336 For Women: MM=(0.29569weight)+(0.41813height)-43.2933	—

Measure

Time frame

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

—

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