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New treatment option for Microbiome Dysbiosis
Official title Colon-delivered Riboflavin and Gut Microbiota Composition
ClinicalTrials.gov ID: NCT07093463
What this study is testing
- What it's testing
- Recent studies suggest B-vitamins such as riboflavin to possess prebiotic-like effects. However, there is still a lack of understanding of the exact host health benefits vs.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Individuals providing written informed consent for participation in the study and data processing
- Female and males between 50 and 70 years of age
- For females only: Menopausal as marked by at least 1 year since the last menstrual bleeding
- Individuals with a BMI between 18.5 - 29.9 Kg/m2
- Individuals with stable body weight (≤5% change) over the past 3 months prior to V1
You likely can't join if
- Individuals who are hypersensitive/intolerant to any of the components of the Investigational product or the standardised diet addition (inulin)
- Individuals who have taken systemic antibiotics within the previous 3 months prior to Baseline (V2) or are expected to be taking any during the study
- Individuals who consumed microbiome modulating dietary supplements, prebiotic, probiotic, or fibre-rich supplements within 4 weeks prior to the...
- Individuals who are currently regularly using systemic steroids, proton pump inhibitors, H2 blocker, antacids (however, sporadic use during the study...
- Individuals who have a history of drug abuse in the previous 5 years and/or alcohol abuse at the time of enrolment (\>11 units/week for women; \>17...
- Individuals who are a smoker or vaper
See the full eligibility criteria
Who can join
- Individuals providing written informed consent for participation in the study and data processing
- Female and males between 50 and 70 years of age
- For females only: Menopausal as marked by at least 1 year since the last menstrual bleeding
- Individuals with a BMI between 18.5 - 29.9 Kg/m2
- Individuals with stable body weight (≤5% change) over the past 3 months prior to V1
- Individuals with self-reported moderate bowel complaints in at least last 3 months prior to V1
- Individuals with GSRS score suggestive of moderate bowel complaints, as assessed at V1, for the average condition over the 4 last weeks (all GSRS items have to be answered at V1): indigestion score 3-5 or constipation...
- Individuals with a general good health, as determined by questioning, clinical examination and vital signs (blood pressure, pulse rate) by the investigator at V1
- Individuals willing to avoid consuming gut microbiome modulating dietary supplements, prebiotic, probiotic, synbiotic or fibre-rich supplements during the entire study duration
- Individuals willing to maintain current level of physical activity throughout the entire study duration
- If individuals are taking chronic medications (e.g., antihypertensive medications), they must be willing and expected to maintain the same dosage throughout the study
What rules you out
- Individuals who are hypersensitive/intolerant to any of the components of the Investigational product or the standardised diet addition (inulin)
- Individuals who have taken systemic antibiotics within the previous 3 months prior to Baseline (V2) or are expected to be taking any during the study
- Individuals who consumed microbiome modulating dietary supplements, prebiotic, probiotic, or fibre-rich supplements within 4 weeks prior to the baseline (V2)
- Individuals who are currently regularly using systemic steroids, proton pump inhibitors, H2 blocker, antacids (however, sporadic use during the study if needed is allowed, but not within 8 hours before each visit)...
- Individuals who have a history of drug abuse in the previous 5 years and/or alcohol abuse at the time of enrolment (\>11 units/week for women; \>17 units/week for men; unit: approx. 125 mL of wine or similar / approx...
- Individuals who are a smoker or vaper
- Individuals who are vegetarian or vegan
- Individuals who have made any major dietary changes in the past 3 months prior to Baseline (V2)
- Individuals who have planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study.
- Individuals who have a currently present active eating disorder
- Individuals with self-reported food allergy / intolerance (e.g., lactose, gluten, fructose), as determined by the study investigator
- Clinical significance for any of screening laboratory test results from the blood draw at V1, as per investigator's judgement
- Individuals with a self-reported fibre-rich regular diet, as per investigator's judgement
- Individuals who have a (self-reported) gastrointestinal disorder/disease (e.g., chronic/recurrent diarrhoea, inflammatory bowel disorder, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, bile acid...
- Individuals with GSRS assessed at V1 for the average condition over the 4 last weeks prior to V1 for any score (abdominal pain, reflux score, indigestion, constipation, diarrhoea) \>5 (all GSRS items have to be answered...
- Individuals who have severe or uncontrolled conditions such as type 2 diabetes (FBG ≥ 150 mg/dl from blood draw at V1), psychiatric disorder, respiratory or cardiac illness or any other condition which in the opinion of...
- Individuals who have a history of any gastrointestinal cancer
- Individuals who are severely immunocompromised
- Individuals with alarm features in the past 3 months prior to V1 such as unintentional weight loss (≤5% change), fever, anorectal problems, blood in stool, vomiting
- Individuals who, in the opinion of the investigator are considered to be poor attendees or unlikely for any reason to be able to comply with the study requirements
- If Individuals have been in a recent experimental study, this must have been completed not less than 30 days prior to this study
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, State of Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, State of Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.