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

Phase 1

• Conditions: healthy volunteers; Healthy Volunteers; Healthy Aging

• Registration Number: RPCEC00000429
• Lead Sponsor: Hermanos Ameijeiras Clinical Surgical Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-07
• Last Update Posted: 19 August 2024
• Study Completion: 2025-01-13
• Results First Posted: 2025-03-17

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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.<br>