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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 2
- 主要终点
- Microbiome change in GUT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will double blinded
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Microbiome change in GUT
时间窗: 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.
次要结局
- Presence of L. reuteri AMBV339 in gut(day 0 - day 28)
- Keystone bacterial taxa in gut(day 0 - day 28)
- Vaginal metabolomic profile(day 0 - day 28)
- Microbiome change in vagina(day 0 - day 28)
- Keystone bacterial taxa in vagina(day 0 - day 28)
- co-occurrence patterns of different bacterial taxa in the vaginal microbiome(day 0 - day 28)
- systemic levels of riboflavin (in blood)(day 0 - day 28)
- Vaginal microbiome diversity(day 0 - day 28)
- Presence of L. reuteri AMBV339 in vagina(day 0 - day 28)
- Gut metabolomic profile(day 0 - day 28)
- co-occurrence patterns of different bacterial taxa in the Gut microbiome(day 0 - day 28)
- levels of riboflavin in vagina(day 0 - day 28)
- levels of riboflavin in the gut(day 0 - day 28)
- Short chain Fatty Acid (SCFA) levels in gut(day 0 - day 28)
- Gut microbiome diversity(day 0 - day 28)