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| Name | Class |
|---|---|
| Universiteit Antwerpen | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L. reuteri AMBV339 | Active Comparator | Probiotic strain, 1B AFU (per day for 28 days in capsule format) |
|
| Humiome B2 | Active Comparator | 73 mg colon delivered riboflavin containing 10 mg pure riboflavin (per day for 28 days in capsule format) |
|
| 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) |
|
| Placebo | Placebo Comparator | Microcrystalline cellulose (per day for 28 days in capsule format) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Limosilactobacillus reuteri AMBV339 | Dietary Supplement | Limosilactobacillus reuteri AMBV339 is a probiotic strain |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Immune markers |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lab of Applied Microbiology and Biotechnology, University of Antwerp | Antwerp | Antwerp | 2020 | Belgium |
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Double-blinded, randomized and placebo-controlled clinical trial
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The study will double blinded
| 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 |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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