An interventional study of BioAmicus Complete and Placebo in Infantile Colics, Constipation and Infantile Diarrhea, sponsored by NovoNatum Ltd. Recruiting at 1 site in Russia. Open to participants aged 1 Month to 5 Months. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by NovoNatum Ltd · Not applicable, Interventional, and Treatment
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.
1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.
This study's planned enrollment of 140 is above the median of 75 across 884 interventional studies indexed under Constipation.
Browse Constipation studies →NovoNatum Ltd is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BioAmicus Complete drops
Dietary Supplement: BioAmicus Complete
Sunflower oil
Dietary Supplement: Placebo
BioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria)
Sunflower oil
Constipation or diarrhea
assessed by changes in stool frequency \[number of bowel movements\] and perceived ease of defecation. Episodes per day.
Time frame: 28 days
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 days
Gastroesophageal reflux
GER, assessed by changes in the number of GER episodes per day
Time frame: 28 days
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 days
Weight increase
Change in body weight relative to the baseline
Time frame: 28 days
Started Mar 2026 (actual). Primary completion is estimated for Jun 2026, 3 months after the start.
Of 71 industry-sponsored interventional studies with no phase under Constipation, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's planned 3 months is below that.
Counting every sponsor, half of 314 studies reached it within 14 months; a quarter within 6 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
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