Dietzia safety study

Phase 1

• Conditions: healthy volunteers; Healthy Volunteers

• Registration Number: RPCEC00000421
• Lead Sponsor: Hermanos Ameijeiras Clinical Surgical Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-17
• Study Completion: 2023-12-18
• Results First Posted: 2024-02-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>Intensity of the adverse effect (Mild, Moderate, Severe). Measurement time: After 60 days.<br>

Secondary Outcome Measures

Name	Time	Method
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).<br>Clinical Chemistry: (-Liver enzymes (UKAT/L), -Creatinine (umolL/L), -Urea (mmol/L))<br>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).<br>Hemodynamic Parameters: Systolic blood pressure (mmHg), Diastolic blood pressure (mmHg), Heart rate (bpm).<br>Calculation of muscle mass:<br>For Men: MM=(0.32810*Weight)+(0.33929*height)-29.5336<br>For Women: MM=(0.29569*weight)+(0.41813*height)-43.2933