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).

A 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, and Gut Immunity).

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).

Study Overview

• Status: Completed
• Conditions: Gut Dysbiosis
• Intervention / Treatment: Other: MetProUltima

Detailed Description

A total of up to 14 subjects will be enrolled to get 12 evaluable subjects complete the study.

The potential subjects will be screened as per the inclusion & exclusion criteria only after obtaining written informed consent from the subjects. Subjects having symptoms of gut dysbiosis like burning sensation, bloating nausea and altered bowel habit, digestion issues, aching joints and high tendency of falling sick, chronic fatigue, constipation, diarrhoea will be enrolled in the study. The subjects will be instructed to visit the facility as per the below visits.

Visit 01 (Day -01): Screening, Blood Sample Collection Visit 02 (Day 01): Enrolment, Faecal Sample Collection, Test Product Dispensing Visit 03 (Day 45 ±2 Days): Treatment usage period, Evaluations Visit 04 (Day 90 ±2 Days): Treatment usage period, Evaluations and End of study.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Gujarat
    • Ahmadabad, Gujarat, India, 382481
      • NovoBliss Research Pvt.Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age: 18 to 65 years (both inclusive) at the time of consent.
2. Sex: Healthy males and healthy non-pregnant/non-lactating females.
3. Females of childbearing potential must have a self-reported negative pregnancy test.
4. Subject should have refrigerator at their home for storage of test product.
5. Subjects having history of falling sick frequently in two months.
6. Subjects having gut dysbiosis with either of these three symptoms which includes burning sensation, bloating, nausea, altered bowel habit, digestion issues, aching joints and high tendency of falling sick, chronic fatigue, constipation, diarrhoea etc.
7. If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence).
8. Subjects are willing to give written informed consent and are willing to come for regular follow-up.
9. Subjects who commit not to use other probiotics, symbiotic, prebiotics, medicated treatments or food having high probiotics other than the test product for the entire duration of the study.
10. Subject who has not participated in a similar investigation in the past three months.
11. Willing to use test product throughout the study period.

Exclusion Criteria:

1. Subject with suspected or proved organic causes of constipation, such as Hirschsprung's disease, hypothyroidism, or structural anomalies of the anal canal.
2. Subject with present condition of allergic response to any probiotic product.
3. Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
4. Subjects with any major diseases of the cardiovascular, renal, hepatic, gastrointestinal, pulmonary or endocrine systems.
5. History of alcohol or drug addiction.
6. Subjects with a history of major gastrointestinal complications (i.e. Crohn's disease, ulcer, cancer, ulcerative colitis).
7. Subjects who have self-reported immuno-compromised (HIV positive, on anti-rejection medication, rheumatoid arthritis).
8. Pregnant or breastfeeding or planning to become pregnant during the study period.
9. Subjects participating in other similar product or therapeutic trials within the last four weeks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MetProUltima; Test product Name: MetProUltima Marketed By| Manufactured By: Meteoric Biopharmaceuticals Private Limited Mode of Usage: Take one capsule after each meal, twice daily. Frequency: Twice a Day Route of Administration: Oral	Other: MetProUltima; Test product Name: MetProUltima Marketed By| Manufactured By: Meteoric Biopharmaceuticals Private Limited Mode of Usage: Take one capsule after each meal, twice daily. Frequency: Twice a Day Route of Administration: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NovoBliss Research Pvt Ltd
• Collaborators: Meteoric Biopharmaceuticals Pvt. Ltd.
• Investigators: Principal Investigator: Dr. Nayan K Patel, NovoBliss Research Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Actual): February 7, 2025
• Study Completion (Actual): February 7, 2025

Study Registration Dates

• First Submitted: August 11, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Signs and Symptoms, Digestive; Dysbiosis; Constipation; Heartburn
• Other Study ID Numbers: NB240019-MB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No