Clinical trial NCT04262648: Randomized Placebo-controlled Study of L. Reuteri NCIMB 30351 in GI Functional Disorders and Food Allergy in Newborns
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infantile Colic
Constipation
Infantile Diarrhea
Gastro Esophageal Reflux
Lead sponsor: NovoNatum Ltd
Sponsor class: INDUSTRY
First posted: 2020-02-10
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the number of infantile colics
timeFrame: 25 days from the start of treatment
Secondary outcomes:
measure: Change in the number of constipations
timeFrame: 25 days from the start of treatment
measure: Change in the number of diarrhea cases
timeFrame: 25 days from the start of treatment
measure: Change in the number of gastroesophageal reflux (posseting) cases
timeFrame: 25 days from the start of treatment
measure: Presence of skin symptoms of food allergy
timeFrame: 25 days from the start of treatment
measure: Change in 16S RNA sequencing
timeFrame: 25 days from the start of treatment
measure: Change in concentrations of stool carbohydrates
timeFrame: 25 days from the start of treatment
measure: Change in concentrations in stool filtrate of volatile fatty acids
timeFrame: 25 days from the start of treatment
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Children's City Clinical Hospital named after Bashlyaeva, Healthcare department of Moscow city
city: Moscow
country: Russian Federation
facility: Medical Center "St. Andrew's Hospitals - NEBOLIT"
Study officials:
affiliation: NovoNatum CEO
name: Oleg Tyrsin
role: STUDY_DIRECTOR
References: