BioAmicus Complete probiotic drops for infant tummy and skin issues

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

This is a randomized, single-blind, placebo-controlled trial enrolling about 140 infants randomized 1:1 to BioAmicus Complete oral drops or placebo for 25 days, with allowed symptomatic therapies such as simethicone or dill water. Infants aged 1 month to 4 months 28 days who present with functional gastrointestinal symptoms (colic, constipation, diarrhea, reflux) or cutaneous signs of food allergy are eligible; very early preterm infants and those with interfering conditions are excluded. Parents/guardians complete a daily observation diary to record symptoms and treatment adherence, and outcomes compare symptom changes between the probiotic and placebo groups. The sponsor is NovoNatum Ltd and the single listed site is a city polyclinic in Saint Petersburg, Russia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The child's parents/guardians speak Russian, have been informed about the study's purpose, understand its essence, are aware of their rights, and have signed the informed consent form.
* Diarrhea or constipation accompanied by colic and/or regurgitation (gastroesophageal reflux, GER).
* Cutaneous manifestations of food allergy.
* The child was born at term or preterm, but not before the 7th month of gestation.
* Age at the time of parental informed consent: from 1 month to 4 months and 28 days.
* The child is on breastfeeding, formula feeding, or mixed feeding.
* The child has no other health conditions that would require a specialized diet.
* The parents/guardians are able and willing to regularly complete the proposed observation diary form.

Exclusion Criteria:

* The child has a congenital pathology or any other conditions/diseases/clinical manifestations that may interfere with participation in the study.
* Use of lactase supplements.
* Use of other probiotic products, antibiotics, enteral antiseptics, antifungal, or antiprotozoal medications.
* The child was born preterm (before the 7th month of gestation).

Where it's running

• St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 43"
  Saint Petersburg, Russia Recruiting

Study contacts

• Study coordinator: Oleg Tyrsin
• Email: vb@novonatum.com
• Phone: +7 985 784 3151

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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.