Randomized Placebo-controlled Study of L. Reuteri NCIMB 30351 in GI Functional Disorders and Food Allergy in Newborns

Study Overview
=================
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.

Official Title
-----------------
Randomized, Blinded, Placebo-controlled, Study of Clinical and Laboratory Effects of L. Reuteri NCIMB 30351 in Functional Disorders of Gastrointestinal Tract and Skin Symptoms of Food Allergy in Children During the First Months of Life

Conditions
-----------------
Infantile Colic, Constipation, Infantile Diarrhea, Gastro Esophageal Reflux

Intervention / Treatment
-----------------
* Dietary Supplement: Lactobacillus Reuteri
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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). Vaginal delivery. Full-term newborn. Age at the time of the signing of informed consent form 1-4 months 28 days. Breast- and formula-fed infants. Colic , constipation , diarrhea, regurgitation (single symptom or combination of several symptoms). Infant does not have other deviations in health, which would require the appointment of a specialized diet Parents / guardians can and ready to regularly fill out the proposed diary form. Exclusion Criteria: Born by Cesarean section. Premature newborn. Congenital abnormalities or other clinical manifestations that may interfere with the study. Lactase food supplements. Other probiotic drugs, antibiotics, enteric antiseptics, antifungal and antiprotozoal drugs.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 5 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Dietary Supplement: Lactobacillus Reuteri<br>* Lactobacillus Reuteri NCIMB 30351<br>* Other names: BioAmicus Lactobacillus drops;|
| Placebo Comparator: Control<br> | Dietary Supplement: Placebo<br>* Sunflower oil<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |