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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bioamicus Complete | Experimental | BioAmicus Complete drops |
|
| Placebo | Placebo Comparator | Sunflower oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioAmicus Complete | Dietary Supplement | BioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Constipation or diarrhea | assessed by changes in stool frequency [number of bowel movements] and perceived ease of defecation. Episodes per day. | 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. | 28 days |
| Gastroesophageal reflux | GER, assessed by changes in the number of GER episodes per day | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cutaneous manifestations of food allergy. | Number of patientswithhe presence or absence of clinical manifestations of skin symptoms of food allergy (atopic dermatitis/eczema) | 28 days |
| Weight increase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oleg Tyrsin | Contact | +7 985 784 3151 | vb@novonatum.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 43" | Recruiting | Saint Petersburg | 198207 | Russia |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D003968 | Diarrhea, Infantile |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003967 | Diarrhea |
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| Placebo | Dietary Supplement | Sunflower oil |
|
Change in body weight relative to the baseline
| 28 days |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |