Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-04-08 @ 6:26 PM
Study NCT ID:
NCT06687720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-14
First Post:
2024-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Determine the Safety and Efficacy of An Oral Probiotic Supplementation in the Management of Irritable Bowel Syndrome With Protein Digestion.
Sponsor:
NovoBliss Research Pvt Ltd
Organization:
Study Overview
Official Title:
A Preliminary Investigation of the Safety and Effectiveness of Oral Probiotics Supplementation for Management of Irritable Bowel Syndrome: A Randomized, Open Label, Placebo-Arm, Comparative, Interventional, Proof-of-Science Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, two-arm, prospective, interventional, in-use safety and efficacy study of an oral probiotic supplementation in adult subjects having irritable bowel syndrome.
Detailed Description:
A total of the up to 18 adults aged between 18 and 60 years, with irritable bowel syndrome will be enrolled to ensure 16 subjects complete the study.
Subjectsshall be instructed to visit the facility for the following scheduled visits:
* Visit 01 \[Within 30 days\]: Screening, Blood Parameter Assessment.
* Visit 02 \[Day 01\]: Enrolment, Evaluations, Treatment Dispensing.
* Visit 03 \[Day 15 (±2 days)\]: Telephonic follow-up.
* Visit 04 \[Day 30 (±2 days)\]: Treatment End, Final Evaluations.
Subjectsshall be instructed to visit the facility for the following scheduled visits:
* Visit 01 \[Within 30 days\]: Screening, Blood Parameter Assessment.
* Visit 02 \[Day 01\]: Enrolment, Evaluations, Treatment Dispensing.
* Visit 03 \[Day 15 (±2 days)\]: Telephonic follow-up.
* Visit 04 \[Day 30 (±2 days)\]: Treatment End, Final Evaluations.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: