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

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

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.

Study Overview

• Status: Completed
• Conditions: Constipation; Gastro Esophageal Reflux; Infantile Colic; Infantile Diarrhea
• Intervention / Treatment: Dietary supplement: Lactobacillus Reuteri; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Children's City Clinical Hospital named after Bashlyaeva, Healthcare department of Moscow city
  • Moscow, Russian Federation
    • Medical Center "St. Andrew's Hospitals - NEBOLIT"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control	Dietary supplement: Placebo; Sunflower oil
Experimental: Treatment	Dietary supplement: Lactobacillus Reuteri; Lactobacillus Reuteri NCIMB 30351; Other Names: BioAmicus Lactobacillus drops

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

Collaborators and Investigators

• Sponsor: NovoNatum Ltd
• Investigators: Study Director: Oleg Tyrsin, NovoNatum CEO

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Actual): May 16, 2022
• Study Completion (Actual): May 16, 2022

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Immune System Diseases; Hypersensitivity, Immediate; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Infant, Newborn, Diseases; Hypersensitivity; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Diarrhea; Gastroesophageal Reflux; Constipation; Colic; Food Hypersensitivity; Diarrhea, Infantile
• Other Study ID Numbers: BioAmicus-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No