NCT06425081

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)

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: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: dsm-firmenich Switzerland AG · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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 riboflavin,(10mg) 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.

Conditions

• Microbial Colonization

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Limosilactobacillus reuteri AMBV339	Limosilactobacillus reuteri AMBV339 is a probiotic strain
DIETARY_SUPPLEMENT	Humiome B2	Colon-delivered Riboflavin
DIETARY_SUPPLEMENT	Limosilactobacillus reuteri AMBV339 + Humiome B2	Combination of supplements used in arm 1 and 2
DIETARY_SUPPLEMENT	Placebo	Microcrystalline cellulose

Timeline

• Start date: 2024-09-09
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2024-05-22
• Last updated: 2025-05-09

Locations

1 site across 1 country: Belgium