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

University of Aarhus

Status: Enrolling

Conditions: Healthy; Healthy Nutrition

Treatments: Dietary Supplement: B. infantis; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06452199

BEGIN 2024

Details and patient eligibility

About

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. The main questions it aims to answer are:

• Does B. infantis probiotics impact immune function and does it lower the number of bacterial infections and use of antibiotics?
• Does B. infantis probiotics impact overall health, development, growth and wellbeing?
• Does B. infantis probiotics impact inflammatory diseases, allergies and autoimmune diseases

Researchers will compare B. infantis probiotics to a placebo (a look-alike substance that contains no probiotic) to see if B. infantis colonization impact the human immunesystem and various clinical and biochemical health markers.

Participants (parents) will

• Orally administrate the B. infantis probiotic to their newborn child daily in three weeks from 7 days of age.
• Answer baseline and follow up questionnaires in a study app
• Take five stool samples from the child and one stool sample from the mother
• Collect a 4 week of passive dust sample at home (Electrostatic Dust fall Collector)
• Donate one dried bloodspot and one blood sample from their child

Enrollment: 1,000 estimated patients

Sex: All

Ages: 1 to 7 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Multiple pregnancy
• Child diagnosed with immune deficiency, renal, gastrointestinal, hepatic, or endocrine diseases
• Parents expecting to give other probiotics

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,000 participants in 2 patient groups, including a placebo group

B. infantis

Active Comparator group

Description:

The investigational product to be tested is a Probio-Tec® I Stick-0.16 IF, containing 1.0 g of a standardized fine powder consisting of a food constituent, the freeze-dried culture of Bifidobacterium longum subsp. infantis Bifin02 (DSM33361). The infant dietary supplement is supposed to be mixed with a little human milk or clean water.

Treatment:

Dietary Supplement: B. infantis

Placebo

Placebo Comparator group

Description:

Identical looking placebo.

Treatment:

Dietary Supplement: Placebo