AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Probiotic for Infants

RecruitingNAAges 0 Days - 1 DayAllHvidovre University Hospital
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

The BABIES II study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with an 8ยฝ months intervention period from 14 days of age to 9 months of age followed by a 3-months short-term follow-up period until 1 year of age and a possible long-term follow-up until 18 years of age. The study will evaluate the effect of supplementation with a probiotic strain on different health outcomes.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
"Inclusion Criteria" Inclusion Criteria for the pregnant person 1. Pregnant person above 18 years of age in gestational week 36+0-38+0 (at Visit 0) 2. Singleton pregnancy 3. Ability to read and speak Danish 4. Plan to breastfeed 5. Provided voluntary written informed consent. Inclusions Criteria for the newborn 1. Born at full-term โ‰ฅ37+0 2. Birth weight โ‰ฅ 2500 g 3. APGAR score of โ‰ฅ 7 within the first 5 min of life. "Exclusion Criteria" Exclusion Criteria for the pregnant person 1. Pregnancy at 38 weeks + 0 or later at the time of recruitment 2. Pregnancy with significant fetal abnormality at ultrasound scan of the fetus at gestational age 19-20 weeks 3. Alcohol or drug abuse 4. Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre 5. Pregnant person with any contraindications for breastfeeding. Exclusion Criteria for the newborn 1. Congenital disorders that could affect their safety or the study outcome 2. Admission to Neonatal Intensive Care Unit for more than 24 hours 3. Participation in another clinical intervention study which can interfere with this probiotic intervention 4. Probiotics other than the study product.
๐Ÿ’Š

What it tests

  • Probiotic
  • Placebo
๐Ÿ“

Where

2 sites
Hvidovre Hospital
Hvidovre, Denmark
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling
Hvidovre, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy