Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-31 @ 12:51 PM
Study NCT ID:
NCT06646458
Status:
COMPLETED
Last Update Posted:
2025-07-25
First Post:
2024-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Explorative Pilot Study to Gain Insights for a New Senior Milk Powder
Sponsor:
Danone Nutricia
Organization:
Study Overview
Official Title:
Xuanwu Pilot: A Prospective, Interventional, Single-arm, Before-and-after Explorative Pilot to Gain Insights on Gastrointestinal and Related Benefits of the New Senior Milk Powder
Status:
COMPLETED
Status Verified Date:
2025-07
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:
The purpose of this interventional, single-arm pilot study aimed to evaluate the new product that newly developed contains a mixture of prebiotics and probiotics to gain insights of GI function acceptance, microbiological composition and related benefits before and after study product consumption in population aged between 50-70 years.
This project also serves the purpose of formulating conceptual hypothesis and directions of exploration for future research.
The main questions it aims to answer are:
1. Microbiological change from stool samples collected at baseline and in the days after study product usage
2. Gastrointestinal function and acceptance assessed during the study period
3. Health related outcomes assessed via wearable device
4. Any safety events
No comparison group
Participants will:
1. Take study product
2. Visit the study site
3. Collect the stool sample
4. Record daily gastrointestinal tolerance and health data
This project also serves the purpose of formulating conceptual hypothesis and directions of exploration for future research.
The main questions it aims to answer are:
1. Microbiological change from stool samples collected at baseline and in the days after study product usage
2. Gastrointestinal function and acceptance assessed during the study period
3. Health related outcomes assessed via wearable device
4. Any safety events
No comparison group
Participants will:
1. Take study product
2. Visit the study site
3. Collect the stool sample
4. Record daily gastrointestinal tolerance and health data
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?: