A Clinical Study to Assess the Safety and Effectiveness of Test Product in Healthy Adult Human Subjects Having Symptoms of Gut Dysbiosis (Heart Burn, Bloating, Constipation and Gut Immunity).
NCT Number: NCT06572358
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gut Dysbiosis
Interventions: OTHER: MetProUltima
Sponsor: NovoBliss Research Pvt Ltd
Collaborators: Meteoric Biopharmaceuticals Pvt. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 14
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-24
Completion Date: 2024-11-24

Summary:
This is prospective, open-label, single-arm, proof of science, clinical safety and efficacy study of MetProUltima in healthy adult human subjects having symptoms of Gut Dysbiosis (heart burn, bloating, constipation).

Primary Outcome Measures: Changes in stool consistency based on the Bristol Stool Criteria, To evaluate the effectiveness of the test product in terms of change in stool based on the Bristol Stool Criteria categorizes stools into one of seven stool types ranging from type 1 (hard lumps) to type 7 (watery diarrhoea)., Baseline before usage of the test product on Day 01, and after usage of the test product on Day 45 and on Day 90|Change in faecal microbiota using 16s Metagenome sequencing, To evaluate the effectiveness of test product in terms of change in faecal microbiota using 16s Metagenome sequencing, Baseline at Day 1, and on Day 90.|Abbreviated physical examinations in terms of frequency of sensation of defecation, To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of frequency of sensation of defecation according to a 5-point Likert scale, with a score ranging from 0 (no symptoms) to 20 (very severe symptoms, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of bloating, To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of bloating in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of nausea, To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of nausea where scoring determined no nausea=0, mild nausea=1-2, moderate nausea 3-6, and severe nausea7-9, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of altered bowel habit., To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of altered bowel habit in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of digestion issues, To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of digestion issues in which scoring done on yes or no, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of aching joints, To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of aching joints in which scoring done as less than 1 week=1, less than1 month=2, less than 2 months=3 and more than 2 months=4, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of chronic fatigue, To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of chronic fatigue in which scoring done as less than 1 week=1, less than1 month=2, less than 6 months=3 and more than 6 months=4, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of constipation for Frequency of bowel movements, To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Frequency of bowel movements in which scoring done 1-2 times per 1-2 days=1 and less than once per month=4, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of constipation for Completeness: feeling incomplete evacuation, To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Completeness: feeling incomplete evacuation in which scoring done never=0 and always=4, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of constipation for Time: minutes in lavatory per attempt, To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Time: minutes in lavatory per attempt in which scoring done Less than 5=0 and More than 30=4, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of constipation for Failure: unsuccessful attempts for evacuation per 24 hours, To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Failure: unsuccessful attempts for evacuation per 24 hours in which scoring done never=0 and More than 9 =4, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of constipation for Difficulty: painful evacuation effort, To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Difficulty: painful evacuation effort in which scoring done never=0 and always =4, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of constipation for Pain: abdominal pain, To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Pain: abdominal pain in which scoring done never=0 and always =4, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of constipation for Assistance: type of assistance, To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for Assistance: type of assistance in which scoring done without assistance=0 and Digital assistance or enema =2, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of constipation for History: duration of constipation (years), To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of constipation for History: duration of constipation (years) in which scoring done 0=0 and more than 20 =4, Baseline Day 1, Day 45 and on Day 90|Abbreviated physical examinations in terms of diarrhoea, To evaluate the effectiveness of the test product by performing abbreviated physical examinations in terms of diarrhoeawhere score, severe diarrhea - having more than 10 loose, watery stools in a single day (24 hours). Moderate diarrhea -having more than a few but not more than 10 diarrhea stools in a day and Mild, Baseline Day 1, Day 45 and on Day 90
Secondary Outcome Measures: Effectiveness by biomarkers like CRP (C reactive protein)., To assess the effectiveness of the test product by Biomarkers like CRP(C reactive protein), baseline Day 01 and after usage of the test product on Day 90.|Effectiveness by biomarkers like IL-6 (Interleukin-6)., To assess the effectiveness of the test product by Biomarkers IL-6 (Interleukin-6), baseline Day 01 and after usage of the test product on Day 90.|Effectiveness of the test product in terms of subject perception questionnaire where scoring by licert scale where 1 = not at all and 5=Extremely, To assess the effectiveness of the test product in terms of subject perception questionnaire, Baseline before usage of the test product on Day 01 and after usage of the test product, on Day 45 and on Day 90|change in lab parameters-Hemoglobin, To assess the effectiveness of the test product in terms of change in lab parameters Hemoglobin, Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-Hematocrit, To assess the effectiveness of the test product in terms of change in lab parameters Hematocrit, Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-RBC Counts (Red Blood Corpuscle), To assess the effectiveness of the test product in terms of change in lab parameters RBC Counts (Red Blood Corpuscle), Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-MCV (Mean corpuscular volume), To assess the effectiveness of the test product in terms of change in lab parameters MCV (Mean corpuscular volume), Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-MCH (mean corpuscular hemoglobin), To assess the effectiveness of the test product in terms of change in lab parameters MCH (mean corpuscular hemoglobin), Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-MCHC (Mean corpuscular hemoglobin concentration), To assess the effectiveness of the test product in terms of change in lab parameters MCHC (Mean corpuscular hemoglobin concentration), Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-RDW (Red cell distribution width), To assess the effectiveness of the test product in terms of change in lab parameters RDW (Red cell distribution width), Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-WBC Counts (White blood cells), To assess the effectiveness of the test product in terms of change in lab parameters WBC Counts (White blood cells), Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-Neutrophils, To assess the effectiveness of the test product in terms of change in lab parameters Neutrophils, Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-Lymphocytes, To assess the effectiveness of the test product in terms of change in lab parameters Lymphocytes, Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-Eosinophils, To assess the effectiveness of the test product in terms of change in lab parameters Eosinophils, Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-Monocytes, To assess the effectiveness of the test product in terms of change in lab parameters Monocytes, Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-Basophils, To assess the effectiveness of the test product in terms of change in lab parameters Basophils, Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-RBC morphology, To assess the effectiveness of the test product in terms of change in lab parameters RBC morphology, Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-Platelet Count, To assess the effectiveness of the test product in terms of change in lab parameters Platelet Count, Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-Random Blood Sugar, To assess the effectiveness of the test product in terms of change in lab parameters Random Blood Sugar, Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-Total Serum Cholesterol, To assess the effectiveness of the test product in terms of change in lab parameters Total Serum Cholesterol, Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-Triglyceride, To assess the effectiveness of the test product in terms of change in lab parameters Triglyceride, Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-HDL (High-density lipoprotein cholesterol), To assess the effectiveness of the test product in terms of change in lab parameters HDL (High-density lipoprotein cholesterol), Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-LDL (Low-density lipoprotein), To assess the effectiveness of the test product in terms of change in lab parameters LDL (Low-density lipoprotein), Baseline on Day -01 and after usage of the test product on Day 90.|change in lab parameters-Serum Creatinine, To assess the effectiveness of the test product in terms of change in lab parameters Serum Creatinine, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Color, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Color, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Transparency, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Transparency, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Specific Gravity, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Specific Gravity, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -pH, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -pH, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Albumin, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Albumin, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Glucose, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Glucose, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Bile Salts, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Bile Salts, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Bile Pigments, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Bile Pigments, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Bilirubin, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Bilirubin, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Urobilinogen, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Urobilinogen, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Ketone, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Ketone, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Nitrite, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Nitrite, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -RBCs (Red Blood Corpuscle), To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -RBCs (Red Blood Corpuscle), Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Leucocyte, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Leucocyte, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -WBC (White blood cell), To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -WBC (White blood cell), Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Epithelial Cell, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Epithelial Cell, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Casts, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Casts, Baseline on Day -01 and after usage of the test product on Day 90.|change in Urine Routine and Microscopy -Crystals, To assess the effectiveness of the test product in terms of change in Urine Routine and Microscopy -Crystals, Baseline on Day -01 and after usage of the test product on Day 90.|Adverse events, Safety will be determined by treatment-emergent adverse events such as allergies, diarrhoea, bloating, nausea, headache assessed by the study investigator., Baseline Day 1, Day 45 and on Day 90