BioAmicus Complete probiotic drops for infant tummy and skin issues
A Randomized, Single-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Dietary Supplement BioAmicus Complete (Oral Drops; a Mixture of 10 Strains of Lacto- and Bifidobacteria) in Managing Functional Gastrointestinal Disorders and Cutaneous Symptoms of Food Allergy in Infants During the First Months of Life
This test will see if daily BioAmicus Complete probiotic drops help infants (about 1 to 4 months old) with colic, constipation, diarrhea, reflux, or atopic dermatitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 1 Month to 5 Months |
| Sex | All |
| Sponsor | NovoNatum Ltd Industry-sponsored |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT07444008 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Full-term or later-preterm infants aged 1 month to 4 months 28 days with colic, constipation, diarrhea, reflux, or cutaneous manifestations of food allergy whose Russian-speaking parents can complete a daily diary are ideal candidates.
Not a fit: Infants with congenital pathology or other medical conditions that interfere with participation, those using excluded lactase or other probiotic products, and very early preterm infants are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, the drops could reduce GI upset and skin allergy symptoms in young infants and lower the need for other symptomatic treatments.
How similar studies have performed: Previous trials of various probiotics for infant colic and atopic dermatitis have shown mixed results, with some positive findings for certain strains but no consistent, widely replicated success for multi-strain products.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Saint Petersburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.