Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT06572358
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.
Study:
NCT06572358
Study Brief:
Protocol Section:
NCT06572358