Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorNovoNatum Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
BioAmicus Complete
Dietary supplementBioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria)
Placebo
Dietary supplementSunflower oil
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Bioamicus CompleteExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Constipation or diarrhea
assessed by changes in stool frequency \[number of bowel movements\] and perceived ease of defecation. Episodes per day.
Time frame
28 days2
Frequency and duration of colic
assessed by changes in the number of colic episodes, number of crying episodes, and average duration of crying. Episodes per day and duration in minutes.
Time frame
28 days3
Gastroesophageal reflux
GER, assessed by changes in the number of GER episodes per day
Time frame
28 daysSecondary outcomes
1
Cutaneous manifestations of food allergy.
Number of patientswithhe presence or absence of clinical manifestations of skin symptoms of food allergy (atopic dermatitis/eczema)
Time frame
28 days2
Weight increase
Change in body weight relative to the baseline
Time frame
28 daysSponsors and contacts
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Source ClinicalTrials.gov