Constipation, Gastro Esophageal Reflux, Infantile Colic, Infantile Diarrhea
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Sunflower oil
DIETARY_SUPPLEMENTLactobacillus Reuteri
Lactobacillus Reuteri NCIMB 30351
Sponsors
NovoNatum Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Months to 5 Months
Healthy volunteers
No
Inclusion criteria
1. Parents / guardians speak Russian, understand the essence of study, are informed about the purpose of the study, understand their rights and signed informed consent form (ICF). 2. Vaginal delivery. 3. Full-term newborn. 4. Age at the time of the signing of informed consent form 1-4 months 28 days. 5. Breast- and formula-fed infants. 6. Colic , constipation , diarrhea, regurgitation (single symptom or combination of several symptoms). 7. Infant does not have other deviations in health, which would require the appointment of a specialized diet 8. Parents / guardians can and ready to regularly fill out the proposed diary form.
Exclusion criteria
1. Born by Cesarean section. 2. Premature newborn. 3. Congenital abnormalities or other clinical manifestations that may interfere with the study. 4. Lactase food supplements. 5. Other probiotic drugs, antibiotics, enteric antiseptics, antifungal and antiprotozoal drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of infantile colics | 25 days from the start of treatment | Infantile colics are defined according to IV Rome criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of constipations | 25 days from the start of treatment | Constipation is defined according to IV Rome criteria |
| Change in the number of diarrhea cases | 25 days from the start of treatment | Diarrhea is defined according to IV Rome criteria |
| Change in the number of gastroesophageal reflux (posseting) cases | 25 days from the start of treatment | Gastroesophageal reflux is defined according to IV Rome criteria |
| Change in concentrations in stool filtrate of volatile fatty acids | 25 days from the start of treatment | Following volatile fatty acids concentrations will be assessed: acetic, propionic, butyric, valeric, caproic and their isomers |
| Change in 16S RNA sequencing | 25 days from the start of treatment | 16S RNA in stool |
| Change in concentrations of stool carbohydrates | 25 days from the start of treatment | Carbohydrates concentrations will be measured in stool filtrate |
| Presence of skin symptoms of food allergy | 25 days from the start of treatment | Presence or absence of skin symptoms of food allergy will be assessed by investigator during general skin examination |
Countries
Russia
Outcome results
None listed