Clinical safety study of Bacillus subtilis PLssc probiotic

Not Applicable

Completed

• Registration Number: CTRI/2020/09/027827
• Lead Sponsor: Advanced Enzyme Technologies Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-11-15
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 18

Inclusion Criteria

1. Healthy human in the age range of 18 to 65 years (both inclusive) 2. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study. 3. Have voluntarily given written informed consent to participate in this study. 4. Be of normal health as determined by medical history, have sitting systolic blood pressure of >=90 mmHg to <=120 mmHg and diastolic blood pressure of >=60 mmHg or <= 80 mmHg, pulse rate 60 to 90 bpm, clinical examination and laboratory investigations performed within 14 days prior to the commencement of the study. 5. Not on medication for chronic diseases (thyroid, diabetes, CNS depressants, CNS stimulants, asthma, CVD, COPD, or any other diseases which requires daily consumption of medicine for the same)

Exclusion Criteria

1. History of hypersensitivity to any drug or history of allergic reactions/atopy. 2. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations. 3. Presence of disease markers of HIV (Self-reported) 4. Presence of values, which are out of acceptable limits for hemoglobin, RBC count, hematocrit, activated partial thromboplastin time (aPTT), prothrombin time (PT), total white blood cells count, differential WBC count or platelet count. 5. Presence of values which are out of acceptable limits for blood urea nitrogen (BUN), serum creatinine, uric acid, sodium, potassium, calcium, phosphorus, chloride, bicarbonate, alkaline phosphatase (ALP), aspartate amino transferase (AST), alanine amino transferase (ALT), total bilirubin, gamma glutamyl transpeptidase (GGT), albumin, globulin, total protein, cholesterol, triglycerides, lactate dehydrogenase (LDH), creatine phosphokinase (CPK), glucose,. Clinically abnormal chemical and microscopic examination of urine. 6. History of or any complaints suggestive of gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological (including generalized or partial epilepsy), endocrine, vision abnormality, rheumatological, urogenital or hematological disease. 7. Presence of significant infection or known inflammation by selfdeclaration by subject or diagnosed by PI. 8. Presence of acute gastrointestinal symptoms at the time of screening and/or admission (e.g., nausea, vomiting, diarrhea, heart burn). 9. Presence of chronic constipation (less than 3 times a week for 12 weeks) at the time of screening and/or admission. 10. Inability to communicate well with investigator (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide, written informed consent. 11. History of joint pain, stiffness and reduced mobility. 12. Use of tobacco in any form (including cigarette smoking) in the last 6 months 13. History of drug dependence or habitual alcohol abuser. 14. Use of any regular medication (OTC or prescription) within 14 days or any drug metabolizing enzyme modifying medications within 30 days prior to Day 1 of this study. 15. History of intake of chronic medication. 16. Participation in any clinical trial within 12 weeks preceding Day 1 of this study. 17. Volunteers who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months. 18. On any other probiotic or antibiotic mediations 19. Pregnant or breast-feeding women or women with child-bearing potential not using medically acceptable methods of contraception (Self-reported).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Change in safety parameters from baseline to EOT <br/ ><br>2. Assessment of rate of incidence of AE and SAEâ??s <br/ ><br>3. Gastrointestinal symptom questionnaire <br/ ><br>4. European five-dimensional health scale (EQ-5D-5L)] <br/ ><br>5. Bristol stool score <br/ ><br>6. Product acceptability questionnaireTimepoint: Day 1 and 21

Secondary Outcome Measures

Name	Time	Method
Assessment of rate of incidence of AE and SAEâ??s reported during visit 5 (7 days after the end of treatmentTimepoint: Day 28