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Outcome Measures

Primary Outcomes (18)

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 Outcomes (43)

Effectiveness 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).
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
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
Baseline on Day -01 and after usage of the test product on Day 90.
change in lab parameters-Hematocrit
Baseline on Day -01 and after usage of the test product on Day 90.
+38 more secondary outcomes

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

MetProUltima

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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).

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (18)

Secondary Outcomes (43)

Study Arms (1)

MetProUltima

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (18)

Secondary Outcomes (43)

Study Arms (1)

MetProUltima

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations