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Completed

NCT Number: 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)

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.

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Key information

Conditions

Microbial Colonization Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lab of Applied Microbiology and Biotechnology, University of Antwerp

Antwerp, 2020, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Limosilactobacillus reuteri AMBV339

Dietary Supplement

Limosilactobacillus reuteri AMBV339 is a probiotic strain

Humiome B2

Dietary Supplement

Colon-delivered Riboflavin

Limosilactobacillus reuteri AMBV339 + Humiome B2

Dietary Supplement

Combination of supplements used in arm 1 and 2

Placebo

Dietary Supplement

Microcrystalline cellulose

Primary outcomes

  1. Microbiome change in GUT

    Time frame: day 0 - day 28

    • 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.

Secondary outcomes

  1. Microbiome change in vagina

    Time frame: day 0 - day 28

    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.

  2. Gut microbiome diversity

    Time frame: day 0 - day 28

    • 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.

  3. Vaginal microbiome diversity

    Time frame: day 0 - day 28

    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.

  4. Keystone bacterial taxa in gut

    Time frame: day 0 - day 28

    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.

  5. Keystone bacterial taxa in vagina

    Time frame: day 0 - day 28

    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.

  6. Presence of L. reuteri AMBV339 in gut

    Time frame: day 0 - day 28

    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.

  7. Presence of L. reuteri AMBV339 in vagina

    Time frame: day 0 - day 28

    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.

  8. co-occurrence patterns of different bacterial taxa in the Gut microbiome

    Time frame: day 0 - day 28

    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.

  9. co-occurrence patterns of different bacterial taxa in the vaginal microbiome

    Time frame: day 0 - day 28

    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.

  10. Gut metabolomic profile

    Time frame: day 0 - day 28

    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.

  11. Vaginal metabolomic profile

    Time frame: day 0 - day 28

    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.

  12. levels of riboflavin in the gut

    Time frame: day 0 - day 28

    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.

  13. levels of riboflavin in vagina

    Time frame: day 0 - day 28

    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.

  14. systemic levels of riboflavin (in blood)

    Time frame: day 0 - day 28

    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.

  15. Short chain Fatty Acid (SCFA) levels in gut

    Time frame: day 0 - day 28

    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.

Other outcomes

  1. Excreted levels of riboflavin (in urine)

    Time frame: day 0 - day 28

    To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on the excreted levels of riboflavin (in urine). Comparisons will be made between the active groups and with placebo.

  2. Immune markers

    Time frame: day 0 - day 28

    To investigate the effect of 28 days of supplementation with either Humiome B2 or L. reuteri AMBV339 or their combination on key anti-inflammatory and cytokine markers in the vagina , assessed by ELISA (e.g., beta-defensin-1 and secretory IgA as well as a broad panel of protein biomarkers). Comparisons will be made between the active groups and with placebo.

  3. General GIT health

    Time frame: day 0 - day 28

    To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on GIT health will be measured using the GSRS questionnaire. Comparisons will be made between the active groups and with placebo.

  4. General Vaginal health

    Time frame: day 0 - day 28

    To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on general Vaginal health will measured using a Ph meter. Comparisons will be made between the active groups and with placebo.

  5. General host health: Body temperature

    Time frame: day 0 - day 28

    To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on host Body temperature using a thermometer. Comparisons will be made between the active groups and with placebo.

  6. General host health: Pulse rate

    Time frame: day 0 - day 28

    To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on host Pulse rate using a pulse rate monitor. Comparisons will be made between the active groups and with placebo.

  7. General host health: Respiration rate

    Time frame: day 0 - day 28

    To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on host Respiration rate by counting the number of chest rises per minute in rest mode. Comparisons will be made between the active groups and with placebo.

  8. General host health: Blood pressure

    Time frame: day 0 - day 28

    To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on host Blood pressure sphygmomanometer. Comparisons will be made between the active groups and with placebo.

  9. User satisfaction of investigational product

    Time frame: day 0 - day 28

    To investigate the effect of daily supplementation (for 28 days) with either Humiome B2 or L. reuteri AMBV339 or their combination on user satisfaction levels based on a simple questionnaire of 10 point scale of how they felt before and after intervention (0 being the lowest point and 10 being the highest point). Comparisons will be made between the active groups and with placebo.

Sponsors and collaborators

Lead sponsor

dsm-firmenich Switzerland AG

Industry

Collaborators

  • Universiteit Antwerpen

Registry information

Official study 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)

Acronym: VIAB2L

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 22, 2024
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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