Clinical trial 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Microbial Colonization
Keywords: Probiotic
vitamin
Riboflavin
Vitamin B2
lactobacillus
microbiome
gut microbiome
vaginal microbiome
women's health
gut health
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Universiteit Antwerpen
First posted: 2024-05-22
Enrollment: 185
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded, randomized and placebo-controlled clinical trial
Primary purpose: SCREENING

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.

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.

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

Primary outcomes:
measure: Microbiome change in GUT
timeFrame: day 0 - day 28
Secondary outcomes:
measure: Microbiome change in vagina
timeFrame: day 0 - day 28
measure: Gut microbiome diversity
timeFrame: day 0 - day 28
measure: Vaginal microbiome diversity
timeFrame: day 0 - day 28
measure: Keystone bacterial taxa in gut
timeFrame: day 0 - day 28
measure: Keystone bacterial taxa in vagina
timeFrame: day 0 - day 28
measure: Presence of L. reuteri AMBV339 in gut
timeFrame: day 0 - day 28
measure: Presence of L. reuteri AMBV339 in vagina
timeFrame: day 0 - day 28
measure: co-occurrence patterns of different bacterial taxa in the Gut microbiome
timeFrame: day 0 - day 28
measure: co-occurrence patterns of different bacterial taxa in the vaginal microbiome
timeFrame: day 0 - day 28
measure: Gut metabolomic profile
timeFrame: day 0 - day 28
measure: Vaginal metabolomic profile
timeFrame: day 0 - day 28
measure: levels of riboflavin in the gut
timeFrame: day 0 - day 28
measure: levels of riboflavin in vagina
timeFrame: day 0 - day 28
measure: systemic levels of riboflavin (in blood)
timeFrame: day 0 - day 28
measure: Short chain Fatty Acid (SCFA) levels in gut
timeFrame: day 0 - day 28
Other outcomes:
measure: Excreted levels of riboflavin (in urine)
timeFrame: day 0 - day 28
measure: Immune markers
timeFrame: day 0 - day 28
measure: General GIT health
timeFrame: day 0 - day 28
measure: General Vaginal health
timeFrame: day 0 - day 28
measure: General host health: Body temperature
timeFrame: day 0 - day 28
measure: General host health: Pulse rate
timeFrame: day 0 - day 28
measure: General host health: Respiration rate
timeFrame: day 0 - day 28
measure: General host health: Blood pressure
timeFrame: day 0 - day 28
measure: User satisfaction of investigational product
timeFrame: day 0 - day 28
Locations:
city: Antwerp
country: Belgium
facility: Lab of Applied Microbiology and Biotechnology, University of Antwerp
Study officials:
affiliation: University of Antwerp Department of Family Medicine and Population Health
name: Veronique Verhoeven, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Antwerp Department of Bioscience Engineering
name: Sarah Lebeer, Dr
role: PRINCIPAL_INVESTIGATOR
References: