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)

NCT ID: NCT06425081

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 185 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-09
• Study Completion Date: 2025-01-30

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.

Conditions

Microbial Colonization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: QUADRUPLE

Study Groups

L. reuteri AMBV339

Probiotic strain, 1B AFU (per day for 28 days in capsule format)

Group Type: ACTIVE_COMPARATOR

Limosilactobacillus reuteri AMBV339

Intervention Type: DIETARY_SUPPLEMENT

Limosilactobacillus reuteri AMBV339 is a probiotic strain

Humiome B2

73 mg colon delivered riboflavin containing 10 mg pure riboflavin (per day for 28 days in capsule format)

Group Type: ACTIVE_COMPARATOR

Humiome B2

Intervention Type: DIETARY_SUPPLEMENT

Colon-delivered Riboflavin

Combination arm

Probiotic strain, 1B AFU + 73 mg colon delivered riboflavin containing 10 mg pure riboflavin (per day for 28 days in capsule format)

Group Type: ACTIVE_COMPARATOR

Limosilactobacillus reuteri AMBV339 + Humiome B2

Intervention Type: DIETARY_SUPPLEMENT

Combination of supplements used in arm 1 and 2

Placebo

Microcrystalline cellulose (per day for 28 days in capsule format)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Microcrystalline cellulose

Interventions

Limosilactobacillus reuteri AMBV339

Limosilactobacillus reuteri AMBV339 is a probiotic strain

Intervention Type: DIETARY_SUPPLEMENT

Humiome B2

Colon-delivered Riboflavin

Intervention Type: DIETARY_SUPPLEMENT

Limosilactobacillus reuteri AMBV339 + Humiome B2

Combination of supplements used in arm 1 and 2

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Microcrystalline cellulose

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veronique Verhoeven, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Antwerp Department of Family Medicine and Population Health

Sarah Lebeer, Dr

Role: PRINCIPAL_INVESTIGATOR

University of Antwerp Department of Bioscience Engineering

Locations

Lab of Applied Microbiology and Biotechnology, University of Antwerp

Antwerp, Antwerp, Belgium

Countries

Belgium

Other Identifiers

2023-07-14-VIAB

Identifier Type: -

Identifier Source: org_study_id