Microbial ColonizationVIAB2LNCT06425081
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)
A study testing Limosilactobacillus reuteri AMBV339, Humiome B2 and Limosilactobacillus reuteri AMBV339 + Humiome B2 in people with Microbial Colonization, run by dsm-firmenich Switzerland AG at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Limosilactobacillus reuteri AMBV339, Humiome B2 and Limosilactobacillus reuteri AMBV339 + Humiome B2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Sep 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Lab of Applied Microbiology and Biotechnology, University of Antwerp
Antwerp, Antwerp, 2020
About this study
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)
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.
Read the 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.
- Conditions
- Microbial Colonization
- Being tested
- Limosilactobacillus reuteri AMBV339, Humiome B2, Limosilactobacillus reuteri AMBV339 + Humiome B2, Placebo
- Keywords
- Probiotic, vitamin, Riboflavin, Vitamin B2, lactobacillus, microbiome, gut microbiome, vaginal microbiome, women's health, gut health
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limosilactobacillus reuteri AMBV339Dietary supplement
Limosilactobacillus reuteri AMBV339 is a probiotic strain
Humiome B2Dietary supplement
Colon-delivered Riboflavin
Limosilactobacillus reuteri AMBV339 + Humiome B2Dietary supplement
Combination of supplements used in arm 1 and 2
PlaceboDietary supplement
Microcrystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri AMBV339 | Active comparator | Probiotic strain, 1B AFU (per day for 28 days in capsule format) Receives: Dietary Supplement: Limosilactobacillus reuteri AMBV339 |
| Humiome B2 | Active comparator | 73 mg colon delivered riboflavin containing 10 mg pure riboflavin (per day for 28 days in capsule format) Receives: Dietary Supplement: Humiome B2 |
| Combination arm | Active comparator | Probiotic strain, 1B AFU + 73 mg colon delivered riboflavin containing 10 mg pure riboflavin (per day for 28 days in capsule format) Receives: Dietary Supplement: Limosilactobacillus reuteri AMBV339 + Humiome B2 |
| Placebo | Placebo comparator | Microcrystalline cellulose (per day for 28 days in capsule format) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome change in GUT
- 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.
Measured: day 0 - day 28
Secondary outcomes (15)
Microbiome change in vagina
To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the microbiome composition (relative abundance of different taxa) in the vagina. Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
Gut microbiome diversity
- To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the microbiome diversity in the GIT. Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
Vaginal microbiome diversity
To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the microbiome diversity in the vagina. Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
Keystone bacterial taxa in gut
To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the relative abundance levels of keystone taxa in the GIT. Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
Keystone bacterial taxa in vagina
To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the relative abundance levels of keystone taxa in the vagina. Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
Presence of L. reuteri AMBV339 in gut
To investigate the effect of daily supplementation (for 28 days) with either L. reuteri AMBV339 or its combination with Humiome B2 on the presence, persistence and/or engraftment of L. reuteri AMBV339 in the GIT during the intervention and 1 week after the end of supplementation. Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
Presence of L. reuteri AMBV339 in vagina
To investigate the effect of daily supplementation (for 28 days) with either L. reuteri AMBV339 or its combination with Humiome B2 on the presence, persistence and/or engraftment of L. reuteri AMBV339 in the vagina during the intervention and 1 week after the end of supplementation. Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
co-occurrence patterns of different bacterial taxa in the Gut microbiome
To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on co-occurrence patterns of different bacterial taxa in the GIT, with particular attention to the possible role of riboflavin as an extracellular electron transfer molecule. Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
co-occurrence patterns of different bacterial taxa in the vaginal microbiome
To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on co-occurrence patterns of different bacterial taxa in the vagina, with particular attention to the possible role of riboflavin as an extracellular electron transfer molecule. Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
Gut metabolomic profile
To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the metabolomic profile in the GIT. Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
Vaginal metabolomic profile
To investigate if daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination modulate the metabolomic profile in the vagina. Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
levels of riboflavin in the gut
To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on the levels of riboflavin in the GIT. Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
levels of riboflavin in vagina
To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination for 28 days on the levels of riboflavin in the vagina. Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
systemic levels of riboflavin (in blood)
To investigate the effect of 28 days of supplementation with either Humiome B2 or L. reuteri AMBV339 or their combination on the systemic levels of riboflavin (in blood). Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
Short chain Fatty Acid (SCFA) levels in gut
To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on the levels of short-chain fatty acids (SCFAs) and related metabolites in the GIT. Comparisons will be made between the active groups and with placebo.
Measured: day 0 - day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start9 Sep 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, randomized and placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Sponsor
- Investigators
- Veronique Verhoeven, Dr, Principal investigator, University of Antwerp Department of Family Medicine and Population HealthSarah Lebeer, Dr, Principal investigator, University of Antwerp Department of Bioscience Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425081
- Sponsor's protocol ID
- 2023-07-14-VIAB
- Acronym
- VIAB2L
- Status last verified
- Sep 2024
- First submitted
- 8 May 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06425081
- Acronym / sponsor ID
- VIAB2L / 2023-07-14-VIAB
- Conditions
- Microbial Colonization
- Keywords
- Probiotic, vitamin, Riboflavin, Vitamin B2, lactobacillus, microbiome, gut microbiome, vaginal microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Collaborators
- Universiteit Antwerpen
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 22 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blinded, randomized and placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| L. reuteri AMBV339 | Active comparator | Dietary Supplement: Limosilactobacillus reuteri AMBV339Probiotic strain, 1B AFU (per day for 28 days in capsule format) |
| Humiome B2 | Active comparator | Dietary Supplement: Humiome B273 mg colon delivered riboflavin containing 10 mg pure riboflavin (per day for 28 days in capsule format) |
| Combination arm | Active comparator | Dietary Supplement: Limosilactobacillus reuteri AMBV339 + Humiome B2Probiotic strain, 1B AFU + 73 mg colon delivered riboflavin containing 10 mg pure riboflavin (per day for 28 days in capsule format) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMicrocrystalline cellulose (per day for 28 days in capsule format) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Limosilactobacillus reuteri AMBV339Limosilactobacillus reuteri AMBV339 is a probiotic strain | Dietary supplement | L. reuteri AMBV339 |
| Humiome B2Colon-delivered Riboflavin | Dietary supplement | Humiome B2 |
| Limosilactobacillus reuteri AMBV339 + Humiome B2Combination of supplements used in arm 1 and 2 | Dietary supplement | Combination arm |
| PlaceboMicrocrystalline cellulose | Dietary supplement | Placebo |
Primary outcome
Microbiome change in GUT
Time frame: day 0 - day 28
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.
15 secondary outcomes
Microbiome change in vagina
Time frame: day 0 - day 28
Gut microbiome diversity
Time frame: day 0 - day 28
Vaginal microbiome diversity
Time frame: day 0 - day 28
Keystone bacterial taxa in gut
Time frame: day 0 - day 28
Keystone bacterial taxa in vagina
Time frame: day 0 - day 28
Presence of L. reuteri AMBV339 in gut
Time frame: day 0 - day 28
Presence of L. reuteri AMBV339 in vagina
Time frame: day 0 - day 28
co-occurrence patterns of different bacterial taxa in the Gut microbiome
Time frame: day 0 - day 28
co-occurrence patterns of different bacterial taxa in the vaginal microbiome
Time frame: day 0 - day 28
Gut metabolomic profile
Time frame: day 0 - day 28
Vaginal metabolomic profile
Time frame: day 0 - day 28
levels of riboflavin in the gut
Time frame: day 0 - day 28
levels of riboflavin in vagina
Time frame: day 0 - day 28
systemic levels of riboflavin (in blood)
Time frame: day 0 - day 28
Short chain Fatty Acid (SCFA) levels in gut
Time frame: day 0 - day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique Verhoeven, Dr principal investigator
University of Antwerp Department of Family Medicine and Population Health
Sarah Lebeer, Dr principal investigator
University of Antwerp Department of Bioscience Engineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Limosilactobacillus reuteri AMBV339, Humiome B2 and Limosilactobacillus reuteri AMBV339 + Humiome B2 in people with Microbial Colonization, run by dsm-firmenich Switzerland AG at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome change in GUT (time frame: day 0 - day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.