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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)

NCT06425081 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2025-05-09

No results posted yet for this study

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.

Conditions

  • Microbial Colonization

Interventions

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

Sponsors & Collaborators

  • Universiteit Antwerpen

    collaborator OTHER

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Veronique Verhoeven, Dr · University of Antwerp Department of Family Medicine and Population Health

  • Sarah Lebeer, Dr · University of Antwerp Department of Bioscience Engineering

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2025-01-30
Completion
2025-01-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06425081 on ClinicalTrials.gov