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)

Sponsored by dsm-firmenich Switzerland AG

About this trial

Last updated a year ago

Study ID

2023-07-14-VIAB

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Yes

Accepting

18 to 45 Years

Female

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

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