Infantile ColicsNCT07444008
Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete
A study testing BioAmicus Complete in people with Infantile Colics and Constipation, run by NovoNatum Ltd at 1 site in Russia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 month to 5 months
- Conditions the study is for
- Infantile Colics, Constipation, Infantile Diarrhea
- What is being tested?
- BioAmicus Complete
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteRussia
- Study dates
- 16 Mar 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 43"
Saint Petersburg, 198207
Sergey Rodygin, +7 (812) 403-03-34, gp43@mail.ru
About this study
Official title: 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 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.
Read more
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.
- Conditions
- Infantile Colics, Constipation, Infantile Diarrhea, Atopic Dermatitis
- Being tested
- BioAmicus Complete, Placebo
- Medical subject headings
- Constipation, Diarrhea, Infantile, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioAmicus CompleteDietary supplement
BioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria)
PlaceboDietary supplement
Sunflower oil
| Study group | Role | What they receive |
|---|---|---|
| Bioamicus Complete | Experimental | BioAmicus Complete drops Receives: Dietary Supplement: BioAmicus Complete |
| Placebo | Placebo comparator | Sunflower oil Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constipation or diarrhea
assessed by changes in stool frequency [number of bowel movements] and perceived ease of defecation. Episodes per day.
Measured: 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.
Measured: 28 days
Gastroesophageal reflux
GER, assessed by changes in the number of GER episodes per day
Measured: 28 days
Secondary outcomes (2)
Cutaneous manifestations of food allergy.
Number of patientswithhe presence or absence of clinical manifestations of skin symptoms of food allergy (atopic dermatitis/eczema)
Measured: 28 days
Weight increase
Change in body weight relative to the baseline
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start16 Mar 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile ColicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovoNatum Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444008
- Sponsor's protocol ID
- BioAmicus-002
- Status last verified
- May 2026
- First submitted
- 22 Feb 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07444008
- Acronym / sponsor ID
- BioAmicus-002
- Conditions
- Infantile Colics, Constipation, Infantile Diarrhea, Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- NovoNatum LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioamicus Complete | Experimental | Dietary Supplement: BioAmicus CompleteBioAmicus Complete drops |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSunflower oil |
Who may qualify
- Ages
- 1 month to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioAmicus CompleteBioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria) | Dietary supplement | Bioamicus Complete |
| PlaceboSunflower oil | Dietary supplement | Placebo |
Primary outcome
Constipation or diarrhea
Time frame: 28 days
assessed by changes in stool frequency [number of bowel movements] and perceived ease of defecation. Episodes per day.
Frequency and duration of colic
Time frame: 28 days
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.
Gastroesophageal reflux
Time frame: 28 days
GER, assessed by changes in the number of GER episodes per day
2 secondary outcomes
Cutaneous manifestations of food allergy.
Time frame: 28 days
Weight increase
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioAmicus Complete in people with Infantile Colics and Constipation, run by NovoNatum Ltd at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oleg Tyrsin (+7 985 784 3151, vb@novonatum.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constipation or diarrhea (time frame: 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.