Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572358
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None