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)
VIAB2L
1 other identifier
interventional
185
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 8, 2024
CompletedFirst Posted
Study publicly available on registry
May 22, 2024
CompletedStudy Start
First participant enrolled
September 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2025
CompletedMay 9, 2025
September 1, 2024
5 months
May 8, 2024
May 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Microbiome change in GUT
1\. To investigate if daily supplementation (for 28 days) with either Humiome B2 or Limosilactobacillus reuteri AMBV339 or their combination modulate the microbiome composition (relative abundance of different taxa) in the gastrointestinal tract (GIT). Comparisons will be made between the active groups and with placebo.
day 0 - day 28
Secondary Outcomes (15)
Microbiome change in vagina
day 0 - day 28
Gut microbiome diversity
day 0 - day 28
Vaginal microbiome diversity
day 0 - day 28
Keystone bacterial taxa in gut
day 0 - day 28
Keystone bacterial taxa in vagina
day 0 - day 28
- +10 more secondary outcomes
Other Outcomes (9)
Excreted levels of riboflavin (in urine)
day 0 - day 28
Immune markers
day 0 - day 28
General GIT health
day 0 - day 28
- +6 more other outcomes
Study Arms (4)
L. reuteri AMBV339
ACTIVE COMPARATORProbiotic strain, 1B AFU (per day for 28 days in capsule format)
Humiome B2
ACTIVE COMPARATOR73 mg colon delivered riboflavin containing 10 mg pure riboflavin (per day for 28 days in capsule format)
Combination arm
ACTIVE COMPARATORProbiotic strain, 1B AFU + 73 mg colon delivered riboflavin containing 10 mg pure riboflavin (per day for 28 days in capsule format)
Placebo
PLACEBO COMPARATORMicrocrystalline cellulose (per day for 28 days in capsule format)
Interventions
Limosilactobacillus reuteri AMBV339 is a probiotic strain
Combination of supplements used in arm 1 and 2
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.)
- Participation in another clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DSM Nutritional Products, Inc.lead
- Universiteit Antwerpencollaborator
Study Sites (1)
Lab of Applied Microbiology and Biotechnology, University of Antwerp
Antwerp, Antwerp, 2020, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Veronique Verhoeven, Dr
University of Antwerp Department of Family Medicine and Population Health
- PRINCIPAL INVESTIGATOR
Sarah Lebeer, Dr
University of Antwerp Department of Bioscience Engineering
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The study will double blinded
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2024
First Posted
May 22, 2024
Study Start
September 9, 2024
Primary Completion
January 30, 2025
Study Completion
January 30, 2025
Last Updated
May 9, 2025
Record last verified: 2024-09