NCT06572358

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).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gut Dysbiosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-22
• Primary completion: 2025-02-07
• Completion: 2025-02-07
• First posted: 2024-08-27
• Last updated: 2025-03-03

Locations

1 site across 1 country: India