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)

Microbial Colonization Clinical Trial

— VIAB2L  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06425081
• Other study ID #: 2023-07-14-VIAB
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: June 2024
• Source: DSM Nutritional Products, Inc.
• Contact: Sarah Ahannach, Dr
• Phone: +32 3 265 32 17
• Email: Sarah.Ahannach[@]uantwerpen.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 CFU), 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

Dietary Supplement:
• Limosilactobacillus reuteri AMBV339
Limosilactobacillus reuteri AMBV339 is a probiotic strain
• Humiome B2
Colon-delivered Riboflavin
• L. reuteri AMBV339 ca. 1x109 CFU per capsule + Humiome B2
Combination of supplements used in arm 1 and 2
• Placebo
Microcrystalline cellulose

Locations

Country	Name	City	State
Belgium	Lab of Applied Microbiology and Biotechnology, University of Antwerp	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
DSM Nutritional Products, Inc.	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Excreted levels of riboflavin (in urine)	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.	day 0 - day 28
Other	Immune markers	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.	day 0 - day 28
Other	General GIT health	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.	day 0 - day 28
Other	General Vaginal health	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.	day 0 - day 28
Other	General host health: Body temperature	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.	day 0 - day 28
Other	General host health: Pulse rate	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.	day 0 - day 28
Other	General host health: Respiration rate	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.	day 0 - day 28
Other	General host health: Blood pressure	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.	day 0 - day 28
Other	User satisfaction of investigational product	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.	day 0 - day 28
Primary	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	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.	day 0 - day 28
Secondary	Gut microbiome diversity	2. 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.	day 0 - day 28
Secondary	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.	day 0 - day 28
Secondary	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.	day 0 - day 28
Secondary	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.	day 0 - day 28
Secondary	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.	day 0 - day 28
Secondary	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.	day 0 - day 28
Secondary	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.	day 0 - day 28
Secondary	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.	day 0 - day 28
Secondary	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.	day 0 - day 28
Secondary	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.	day 0 - day 28
Secondary	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.	day 0 - day 28
Secondary	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.	day 0 - day 28
Secondary	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.	day 0 - day 28
Secondary	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.	day 0 - day 28