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)

Launched by DSM NUTRITIONAL PRODUCTS, INC. · May 17, 2024

Keywords

ClinConnect Summary

The VIAB2L Project is a clinical trial that aims to understand how a specific probiotic (a type of beneficial bacteria called Limosilactobacillus reuteri AMBV339) and a special form of riboflavin (Vitamin B2) can affect the gut and vaginal bacteria in healthy adult women. Researchers want to see if these treatments, either alone or together, can change the balance of bacteria in these areas and improve overall health. Over a period of 28 days, participants will receive either the probiotic, the riboflavin, a combination of both, or a placebo (a substance that looks like the treatments but has no active ingredients).

To be part of this study, women must be between 18 and 45 years old, in good health, and living in Flanders while speaking Dutch. They should also be using a specific type of contraceptive during the study. However, women who are pregnant, breastfeeding, or have certain health issues—like infections or gastrointestinal disorders—won't be eligible. Participants can expect to attend regular visits and provide information about their health and experiences during the trial. This study is essential for learning more about how probiotics and vitamins can support women's health.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women of reproductive age (appr. 18-45 years old)
• • Women of self-reported good general health
• • Living in Flanders and speaking Dutch
• • Using a combination contraceptive pill (without stop week) during the study and preferably at least three months before the study OR having a hormonal intrauterine device during the study and preferably at least three months before the study
• • Subjects willing and able to give written informed consent and to understand, to participate and to comply with the clinical study requirements.
• Exclusion Criteria:
• • Current pregnancy or breastfeeding
• • Antibiotic/antimycotic use during the last three months before the study
• • Use of group B vitamin supplements or vitamin C during the study (record vitamin use via questionnaires)
• • Ketogenic diet during the study and during the last two weeks before the study
• • Oral and vaginal probiotic, prebiotic, and postbiotic and synbiotic supplementation during the study or recent use during the last two weeks before the study
• • Vaginal douching during the study
• • Presence of general infection
• • Having a reproductive disorder or current vaginal infection or vaginal symptoms (VVC, BV, AV, etc.)
• • Having a gastro-intestinal disorder or current GIT infections or gastrointestinal disorders (Crohn, IBS, IBD, etc.)
• • Having any other medical condition that gives rise to exclusion from the study according to the responsible clinician/principal investigator of the study
• • Participation in another clinical trial