The present study is a randomized, placebo-controlled, parallel-group, double-blind clinical study. Seventy-eight individuals will be screened, and considering a screening failure rate of 20%, approximately 64 participants will be randomized in a ratio of 1:1 to receive either BioPB-01 or Placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
64
Aman Hospital and Research Center
Vadodara, Gujarat, India
Lifecare Hospital
Nashik, Maharashtra, India
To evaluate the safety of 21 days of BioPB-01 administration on
The gastrointestinal (GI) health assessed using a modified Gastrointestinal Symptom Questionnaire (GSQ) compared to baseline and placebo
Time frame: Day 21
To evaluate the safety of 21 days of BioPB-01 administration on
The gastrointestinal (GI) health assessed using a modified Gastrointestinal Symptom Questionnaire (GSQ) compared to baseline and placebo
Time frame: Day 14
To evaluate the safety of 21 days of BioPB-01 administration on
The gastrointestinal (GI) health assessed using a modified Gastrointestinal Symptom Questionnaire (GSQ) compared to baseline and placebo
Time frame: Day 7
To evaluate the safety of 21 days of BioPB-01 administration on
Stool consistency using Bristol stool form scale (BSFS) compared to baseline and placebo.This scale is a 7 point ordinal scale of stool types. The participants will be asked to rate their stool consistency and frequency daily to assess abnormal stools, defined as alteration in the frequency or consistency type 1, 2, 6, or 7.
Time frame: Day 21
To evaluate the safety of 21 days of BioPB-01 administration on
Stool consistency using Bristol stool form scale (BSFS) compared to baseline and placebo. The participants will be asked to rate their stool consistency and frequency daily to assess abnormal stools, defined as alteration in the frequency or consistency type 1, 2, 6, or 7.
Time frame: Day 14
To evaluate the safety of 21 days of BioPB-01 administration on
Stool consistency using Bristol stool form scale (BSFS) compared to baseline and placebo. The participants will be asked to rate their stool consistency and frequency daily to assess abnormal stools, defined as alteration in the frequency or consistency type 1, 2, 6, or 7.
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Time frame: Day 7
To evaluate the safety of 21 days of BioPB-01 administration on
Liver function biomarkers Alanine transaminase (ALT) Reference range: Females: 9-52 U/L Males: 21-72 U/L
Time frame: Day 21
To evaluate the safety of 21 days of BioPB-01 administration on
Liver function biomarkers Aspartate aminotransferase (AST) Reference range: Females: 14-36 U/L Males: 17-59 U/L
Time frame: Day 21
To evaluate the safety of 21 days of BioPB-01 administration on
Renal function biomarker blood urea nitrogen (BUN) - Female: 7-17 mg/dL or 2.5-6.1 mmol/L Male: 9-20 mg/dL or 3.2-7.1 mmol/L
Time frame: Day 21
To evaluate the safety of 21 days of BioPB-01 administration on
Renal function biomarker Creatinine Reference range: Female: 0.52-1.04 mg/dL or 46-92 μmol/L Male: 0.66-1.25 mg/dL or 58-110 μmol/L
Time frame: Day 21
To evaluate the safety of 21 days of BioPB-01 administration on
Serum electrolytes (sodium) : 137-145 mmol/L
Time frame: Day 21
To evaluate the safety of 21 days of BioPB-01 administration on
Serum electrolytes (potassium): 3.5-5.1 mmol/L
Time frame: Day 21
To evaluate the safety of 21 days of BioPB-01 administration on
Vitals - Blood pressure : Both Systolic and Diastolic pressure will be measured
Time frame: Day 21
To evaluate the safety of 21 days of BioPB-01 administration on
Vitals - Pulse rate
Time frame: Day 21
To evaluate the safety of 21 days of BioPB-01 administration on
The number and percentage of participants having adverse product reaction (as per CTCAE V5.0)
Time frame: Throughout the study (an average of 21 days)
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing the metabolic health
As assessed by the serum lipid profile (Triglycerides (TG), Total cholesterol (TC), low-density lipoprotein (LDL), and high-density lipoprotein (HDL)) level from Baseline
Time frame: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
The insulin sensitivity as assessed by HOMA-IR from baseline
Time frame: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
The post-prandial insulin response by net incremental area-under-the-curve (AUC) for post-prandial glucose and insulin (30, 60, 90, and 120 min. after standardised meal) from baseline.
Time frame: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Inflammation by serum C-reactive protein (CRP) level from Baseline
Time frame: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Satiety using the Appetite/Satiety - using Visual Analog Scale (VAS) from Baseline. The scale comprises of 4 main domains: 1) Hunger, 2) Fullness after meals, 3) Thoughts of food, 4) Cravings. The appetite will be analysed based on these four domains on a 100 mm VAS. Reduction in scores as compared to day 0 and placebo will indicate improvement in the appetite/satiety and efficacy of the IP on the appetite/satiety.
Time frame: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing
Body weight from baseline.
Time frame: Day 21
To evaluate the efficacy of BioPB-01 after 21 days of administration by assessing Fecal short chain fatty acids (SCFA)
Namely acetate, propionate, and butyrate from Baseline. The samples will be analysed using liquid chromatography tandem mass spectrometry (LC-MS/MS).
Time frame: Day 21