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Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated May 11, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Recruitment openedv3 Show 5 more changesShow less
    • Primary completion pushed from May 30, 2026 to Jun 30, 2026
    • Study completion pushed from Jun 30, 2026 to Jul 30, 2026
    • Start date changed from estimate of Feb 26, 2026 to Mar 16, 2026
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study site revised
  2. Secondary endpoints revised (2)
    • Study title shortened, about 12 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07444008
Lead Sponsor NovoNatum Ltd
Conditions
(from sponsor)		 Infantile Colics, Constipation, Infantile Diarrhea, Atopic Dermatitis
Related terms Constipation, Dermatitis, Atopic, Diarrhea, Infantile
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov