Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete

Sponsor
NovoNatum Ltd
Study ID
NCT07444008
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Month - 5 Months
Healthy Volunteers
Not accepted

Interventions

  • BioAmicus Complete — DIETARY_SUPPLEMENT
    BioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria)
  • Placebo — DIETARY_SUPPLEMENT
    Sunflower oil

Study Details

This is 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. The aim of the study is to assess clinical effects of BioAmicus Complete drops on the symptoms of infantile colic, constipation, diarrhea, gastroesophageal reflux, atopic dermatitis/eczema in full-term newborns during the first months of life. A prospective study comparing two treatment groups: Group 1 (treatment group) - 70 infants. Group 2 (control group) - 70 infants, placebo. The study drug will be taken in 1 time per day within 25 days. Allowed symptomatic therapy includes defoamers (simethicone-based preparations), carminative preparations (dill water (fenhel)), etc.

Key Dates

First listed
Mar 2, 2026
Start date
Mar 16, 2026
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jul 30, 2026

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bioamicus Complete
    BioAmicus Complete drops
  • Placebo Comparator: Placebo
    Sunflower oil

Primary Outcome Measure

Constipation or diarrhea [ Time Frame: 28 days ]

Central Contacts

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