Randomized Placebo-controlled Study of L. Reuteri NCIMB 30351 in GI Functional Disorders and Food Allergy in Newborns
- Conditions
- Infantile ColicConstipationGastro Esophageal RefluxInfantile Diarrhea
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Lactobacillus Reuteri
- Registration Number
- NCT04262648
- Lead Sponsor
- NovoNatum Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Placebo - Treatment Lactobacillus Reuteri -
- Primary Outcome Measures
Name Time Method Change in the number of infantile colics 25 days from the start of treatment Infantile colics are defined according to IV Rome criteria
- Secondary Outcome Measures
Name Time Method 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
Change in concentrations of stool carbohydrates 25 days from the start of treatment Carbohydrates concentrations will be measured in stool filtrate
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 the number of constipations 25 days from the start of treatment Constipation 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
Trial Locations
- Locations (2)
Children's City Clinical Hospital named after Bashlyaeva, Healthcare department of Moscow city
🇷🇺Moscow, Russian Federation
Medical Center "St. Andrew's Hospitals - NEBOLIT"
🇷🇺Moscow, Russian Federation