HealthyBEGINNCT06452199
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
A study testing B. infantis in people with Healthy and Healthy Nutrition, run by University of Aarhus at 2 sites in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy, Healthy Nutrition
- What is being tested?
- B. infantis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 2 sitesDenmark
- Study dates
- 10 Jun 2024to Nov 2043
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Multiple pregnancy
- Child diagnosed with immune deficiency, renal, gastrointestinal, hepatic, or endocrine diseases
- Parents expecting to give other probiotics
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Regional Hospital Gødstrup
Herning, Central Jutland, 7400
Marie T Philipsen, MD, +45 53637369, marie_tholstrup@rm.dk
- Recruiting
Regional Hospital Horsens
Horsens, Central Jutland, 8700
Marie T Philipsen, MD, +45 53637369, marie_tholstrup@rm.dk
About this study
Official title: The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions
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
Read more
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
- Conditions
- Healthy, Healthy Nutrition
- Being tested
- B. infantis, Placebo
- Keywords
- Microbiota, Gastrointestinal Microbiome, Probiotics, Bifidobacterium longum subspecies infantis, Paediatrics, Infant, Child, Immunology, Infections, Inflammation, Growth and Development, Colic, Respiratory Tract Diseases, Metabolism
- Medical subject headings
- Infections, Inflammation, Colic, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. infantisDietary supplement
Also called Bifidobacterium longum subsp. infantis Bifin02 (DSM33361)
1000 newborn children are randomized 50/50 to receive either B. infanits or placebo in a dietary supplement, for daily oral administration in three weeks from 7 days of age.
PlaceboDietary supplement
Identical looking placebo (without any probiotics/B. infantis) for double-blinded daily oral administration in three weeks from 7 days of age.
| Study group | Role | What they receive |
|---|---|---|
| B. infantis | Active comparator | 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. Receives: Dietary Supplement: B. infantis |
| Placebo | Placebo comparator | Identical looking placebo. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescriptions of antibiotics
Number of prescriptions of antibiotics among participants, as a measure of bacterial infections.
Measured: First assessment at 1 year and up to 18 years follow-up
Secondary outcomes (16)
The intestinal microbiota and B. infantis colonization
Stool samples collected during the first year of life and tested with shutgun metagenomics, assessing the microbial composition..
Measured: 1 year
Antibiotic resistance genes (ARGs)
Amount of Antibiotic resistance genes (ARGs) in participants microbial community in stool samples. Identification with shutgun metagenomics. Assessing the microbial composition and diversity.
Measured: 1 year
Colic
Parents' observations registered in study app. Duration of crying in the first three months of life. Defined as Wessels criteria:
Crying for three or more hours a day, three or more days a week, for three or more weeks.
Measured: 3 months
Bowel function, stool consistency
Parents' observations registered in study app, related to their infant child's stool consistency measured at the Infant Stool Scale
Measured: 3 months
Bowel function, stool frequency.
Parents' observations of their infant child's frequency of stool passings, registered in study app
Measured: 3 months
Bowel function, laxatives
Parents' reported use of medical laxatives for their infant child, registered in study app and reported as amount of days using the laxative.
Measured: 3 months
High sensitive C-reactive protein (hs-CRP)
Blood biomarker: Low-grade systemic inflammation. Unit of measurement: mg/l
Measured: 1 year
Cluster of Differentiation 163" (CD163)
Blood biomarker: Macrophage-mediated inflammation and insulin-sensitivity. Unit of measurement: mg/l
Measured: 1 year
Plasma Calprotectin
Blood biomarker: Intestinal inflammation. Unit of measurement: µg/l
Measured: 1 year
Allergies, Immunoglobulin E (IgE)
Blood marker: Allergies. Specific IgE against the 11 most common inhalation allergens and IgE directed against Egg white, cow's milk, codfish, wheat, peanut and soybean. Unit of measurement: IU/l
Measured: 1 year
Allergies
Self reported allergy symptoms
Measured: 1 year
Growth, weight gain
Measured as weight gain in kilograms
Measured: First assessment at 1 year and up to 18 years follow-up
Growth
Growth velocity and weight-for-length z-scores, measured in kilograms and centimeters and combined for Z-scores.
Measured: First assessment at 1 year and up to 18 years follow-up
Growth, IGF-1 (Insulin-like Growth Factor-1)
Blood biomarker: Mediating the growth-promoting effects of growth hormone. Unit of measurement: µg/l
Measured: 1 year
Body composition
Measured by air displacement plethysmography (ADP) (Pea Pod) estimating body fat
Measured: 3 months
Body composition
Measured by air displacement plethysmography (ADP) (Pea Pod) estimating muscle mass.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start10 Jun 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled double-blinded intervention trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Gødstrup Hospital, Regionshospitalet Horsens, Technical University of Denmark, Statens Serum Institut, University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Sune Rubak, MD, Phd, Principal investigator, Department of Paediatrics, Aarhus University Hospital (AUH) and Aarhus UniversityKurt Kristensen, MD, Phd, Principal investigator, Steno Diabetes Centre Aarhus and Department of Paediatrics (AUH) and and Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452199
- Sponsor's protocol ID
- BEGIN 2024
- Acronym
- BEGIN
- Status last verified
- Apr 2024
- First submitted
- 22 May 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data that underlie the results reported in study articles (text, tables, figures, and appendices). The laws related to the handling of personal data will be followed and results are processed in accordance with the General Data Protection Regulation (GDPR) and the Danish Data Protection Act (Databeskyttelsesforordningen and Databeskyttelsesloven).
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BEGIN Study Bifidobacterium Infantis to Newborns: Effects of Modulating the Gut Microbial Composition on Growth, Immune Function and Inflammatory Conditions
- ClinicalTrials.gov ID
- NCT06452199
- Acronym / sponsor ID
- BEGIN / BEGIN 2024
- Conditions
- Healthy, Healthy Nutrition
- Keywords
- Microbiota, Gastrointestinal Microbiome, Probiotics, Bifidobacterium longum subspecies infantis, Paediatrics, Infant, Child, Immunology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Gødstrup Hospital, Regionshospitalet Horsens, Technical University of Denmark, Statens Serum Institut, University of Copenhagen
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2043 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled double-blinded intervention trial
| Arm | Type | Receives |
|---|---|---|
| B. infantis | Active comparator | Dietary Supplement: B. infantisThe 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIdentical looking placebo. |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Multiple pregnancy
- Child diagnosed with immune deficiency, renal, gastrointestinal, hepatic, or endocrine diseases
- Parents expecting to give other probiotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B. infantisAlso: Bifidobacterium longum subsp. infantis Bifin02 (DSM33361)1000 newborn children are randomized 50/50 to receive either B. infanits or placebo in a dietary supplement, for daily oral administration in three weeks from 7 days of age. | Dietary supplement | B. infantis |
| PlaceboIdentical looking placebo (without any probiotics/B. infantis) for double-blinded daily oral administration in three weeks from 7 days of age. | Dietary supplement | Placebo |
Primary outcome
Prescriptions of antibiotics
Time frame: First assessment at 1 year and up to 18 years follow-up
Number of prescriptions of antibiotics among participants, as a measure of bacterial infections.
16 secondary outcomes
The intestinal microbiota and B. infantis colonization
Time frame: 1 year
Antibiotic resistance genes (ARGs)
Time frame: 1 year
Colic
Time frame: 3 months
Bowel function, stool consistency
Time frame: 3 months
Bowel function, stool frequency.
Time frame: 3 months
Bowel function, laxatives
Time frame: 3 months
High sensitive C-reactive protein (hs-CRP)
Time frame: 1 year
Cluster of Differentiation 163" (CD163)
Time frame: 1 year
Plasma Calprotectin
Time frame: 1 year
Allergies, Immunoglobulin E (IgE)
Time frame: 1 year
Allergies
Time frame: 1 year
Growth, weight gain
Time frame: First assessment at 1 year and up to 18 years follow-up
Growth
Time frame: First assessment at 1 year and up to 18 years follow-up
Growth, IGF-1 (Insulin-like Growth Factor-1)
Time frame: 1 year
Body composition
Time frame: 3 months
Body composition
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- studywebsite for participantsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized data that underlie the results reported in study articles (text, tables, figures, and appendices). The laws related to the handling of personal data will be followed and results are processed in accordance with the General Data Protection Regulation (GDPR) and the Danish Data Protection Act (Databeskyttelsesforordningen and Databeskyttelsesloven).
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sune Rubak, MD, Phd principal investigator
Department of Paediatrics, Aarhus University Hospital (AUH) and Aarhus University
Kurt Kristensen, MD, Phd principal investigator
Steno Diabetes Centre Aarhus and Department of Paediatrics (AUH) and and Aarhus University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B. infantis in people with Healthy and Healthy Nutrition, run by University of Aarhus at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie T Philipsen, MD, PhD.stud (+45 53637369, marie.tholstrup@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescriptions of antibiotics (time frame: First assessment at 1 year and up to 18 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.