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).

NovoBliss Research Pvt Ltd14 enrolled

Overview

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).

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

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Gut Dysbiosis

Interventions

MetProUltimaOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

NovoBliss Research Pvt.Ltd

Ahmedabad, Gujarat, India

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline Day 1, Day 45 and on Day 90

Abbreviated physical examinations in terms of altered bowel habit.

Data from ClinicalTrials.gov

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Secondary Outcomes

Effectiveness by biomarkers like CRP (C reactive protein).

To assess the effectiveness of the test product by Biomarkers like CRP(C reactive protein)

Time frame: 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)

Time frame: 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

Time frame: 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