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This study is a randomized, placebo-controlled, single-masked (blinded), post-marketing clinical study of a drug Lactobacillus Reuteri NCIMB 30351 drops in functional disorders of gastrointestinal tract and skin symptoms of food allergies in children between the ages of one and four months inclusive.
The aim of the study is to assess clinical effects of probiotics Lactobacillus Reuteri NCIMB 30351 drops on the symptoms of infantile colic, constipation, diarrhea, gastroesophageal reflux, atopic dermatitis/eczema in full-term newborns during the first months of life, laboratory parameters of microbiome will also be assessed.
A prospective study comparing two treatment groups:
Group 1 (treatment group) - 60 infants. Group 2 (control group) - 30 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 (fennel)), etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
| |
| Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus Reuteri | Dietary Supplement | Lactobacillus Reuteri NCIMB 30351 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of infantile colics | Infantile colics are defined according to IV Rome criteria | 25 days from the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of constipations | Constipation is defined according to IV Rome criteria | 25 days from the start of treatment |
| Change in the number of diarrhea cases | Diarrhea is defined according to IV Rome criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oleg Tyrsin | NovoNatum CEO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's City Clinical Hospital named after Bashlyaeva, Healthcare department of Moscow city | Moscow | Russia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38427038 | Derived | Tyrsin OY, Tyrsin DY, Nemenov DG, Ruzov AS, Odintsova VE, Koshechkin SI, D Amico L. Effect of Lactobacillus reuteri NCIMB 30351 drops on symptoms of infantile functional gastrointestinal disorders and gut microbiota in early infants: Results from a randomized, placebo-controlled clinical trial. Eur J Pediatr. 2024 May;183(5):2311-2324. doi: 10.1007/s00431-024-05473-y. Epub 2024 Mar 1. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 28, 2024 | |
| Reset | Aug 9, 2024 |
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| Placebo | Dietary Supplement | Sunflower oil |
|
| 25 days from the start of treatment |
| Change in the number of gastroesophageal reflux (posseting) cases | Gastroesophageal reflux is defined according to IV Rome criteria | 25 days from the start of treatment |
| Presence of skin symptoms of food allergy | Presence or absence of skin symptoms of food allergy will be assessed by investigator during general skin examination | 25 days from the start of treatment |
| Change in 16S RNA sequencing | 16S RNA in stool | 25 days from the start of treatment |
| Change in concentrations of stool carbohydrates | Carbohydrates concentrations will be measured in stool filtrate | 25 days from the start of treatment |
| Change in concentrations in stool filtrate of volatile fatty acids | Following volatile fatty acids concentrations will be assessed: acetic, propionic, butyric, valeric, caproic and their isomers | 25 days from the start of treatment |
| Medical Center "St. Andrew's Hospitals - NEBOLIT" |
| Moscow |
| Russia |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 28, 2024 | Aug 9, 2024 |
| ID | Term |
|---|---|
| D003085 | Colic |
| D003248 | Constipation |
| D003968 | Diarrhea, Infantile |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003967 | Diarrhea |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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