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Official title The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions - a Randomized Placebo-controlled Double-blinded Intervention Trial
ClinicalTrials.gov ID: NCT06452199
What this study is testing
- What it's testing
- The goal of The BEGIN Study, a randomized controlled double-blinded intervention trial, is to learn if probiotics, with Bifidobacterium longum subspecies infantis Bifin02 (B. infantis), given to healthy newborns can affect various health outcomes and to explore impacts of the infant gastrointestinal microbiome.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 7. Healthy volunteers may be eligible.
You may be able to join if
- Infants born at term (above gestational week 37)
- Infants born in Region Midtjylland Denmark receiving a Danish CPR number.
- Parents age is above 18
- At least one parent holds a smartphone (for study app) and is able to fill out Danish questionaries
- Both legal parents are willing and able to provide written informed consent prior to participation, regarding both themselves and their future child.
You likely can't join if
- Multiple pregnancy
- Child diagnosed with immune deficiency, renal, gastrointestinal, hepatic, or endocrine diseases
- Parents expecting to give other probiotics
The study team makes the final eligibility decision.
Where it's taking place
- Herning, Central Jutland, Denmark
- Horsens, Central Jutland, Denmark
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, 1 day to 7 days. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herning, Central Jutland, Denmark; Horsens, Central Jutland, Denmark. 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.