Probiotic Bifidobacterium bifidum for formula-fed infants with colic (with or without eczema)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Infants who are formula-fed and meet Rome IV criteria for colic, with or without atopic dermatitis, will receive either Bifidobacterium bifidum drops or a placebo for eight weeks. The trial compares the effect on average daily crying time and several secondary outcomes such as crying frequency, sleep quality, bowel movements, stool consistency, gut microbiota, SCFA levels, and SCORAD scores. It uses a randomized, placebo-controlled design to assess safety and efficacy in a young population. The probiotic preparation contains BFP19 and BFP29 strains delivered as Bifipral drops. Eligible participants are non-breastfed infants aged ≤5 months whose guardians provide informed consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Non-breastfed infants aged ≤ 5 months diagnosed with infant colic according to Rome IV criteria, with or without atopic dermatitis.
* Written informed consent from parents or legal guardians.

Exclusion Criteria:

* Age \> 5 months.
* Exclusive breastfeeding or mixed feeding.
* Absence of infant colic diagnosis.
* Presence of chronic diseases, neoplasms, immunodeficiencies, chronic infections, autoimmune diseases, IBD, celiac disease, genetic-metabolic disorders, cystic fibrosis or other chronic pulmonary diseases, cardiovascular/respiratory/GI malformations, neuropsychiatric disorders, neurological conditions, or vegetarian/vegan diet.

Where it's running

• AOU Sant'Andrea
  Roma, Rm, Italy Recruiting

Study contacts

• Principal investigator: Giovanni Di Nardo, Professor — UOC Pediatrics, AOU Sant'Andrea, Rome / Sapienza University of Rome
• Study coordinator: Giovanni Di Nardo, Professor
• Email: giovanni.dinardo@uniroma1.it
• Phone: 0633775870

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.