Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425081
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-08
Brief Title:
Investigating the Impact of Humiome B2 colon Delivered Riboflavin and Riboflavin-overproducer Probiotic Strain Limosilactobacillus Reuteri AMBV339 on Intestinal and Vaginal Microbiome and Health of Healthy Adult Women The VIAB2L Project
Sponsor:
DSM Nutritional Products Inc
Organization:
DSM Nutritional Products Inc
Study Overview
Official Title:
Investigating the Impact of Humiome B2 colon Delivered Riboflavin and Riboflavin-overproducer Probiotic Strain Limosilactobacillus Reuteri AMBV339 on Intestinal and Vaginal Microbiome and Health The VIAB2L Project
Status:
RECRUITING
Status Verified Date:
2024-09
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:
VIAB2L
Brief Summary:
The goal of this clinical trial is to learn if the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination can change the gut and vaginal microbiome and metabolomics It will also learn about the safety of the investigational product The main questions it aims to answer are
Do the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination modify gut microbiome Do the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination modify gut microbiome
Researchers will compare the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination to a placebo a look-alike substance that contains no drug to see if they can change gut and vaginal microbiome Intervention period is 28 days
Do the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination modify gut microbiome Do the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination modify gut microbiome
Researchers will compare the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination to a placebo a look-alike substance that contains no drug to see if they can change gut and vaginal microbiome Intervention period is 28 days
Detailed Description:
The goal of this clinical trial is to learn if the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination can change the gut and vaginal microbiome and metabolomics It will also learn about the safety of the investigational product Participants are healthy adult females of reproductive age and will take the investigational products for 28 days There will be several non-invasive measurements including but not limited to gut microbiome measured in faecal samples and vaginal microbiome measured in vaginal samples They will fill some questionnaires about their general health
The investigational product is a probiotic strain 1 billion AFU colon-delivered riboflavin10mg and their combination
Participants will
Take the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination or a placebo every day for 28 days
Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their bowel habits and provide fecal and vaginal sample at visits
The investigational product is a probiotic strain 1 billion AFU colon-delivered riboflavin10mg and their combination
Participants will
Take the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination or a placebo every day for 28 days
Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their bowel habits and provide fecal and vaginal sample at visits
Study Oversight
Has Oversight DMC:
None
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?:
None