Skip to main content
OpenTrials
Completed

NCT Number: NCT04262648

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infantile Colic Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Constipation Deglutition Disorders Diarrhea Diarrhea, Infantile Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastro Esophageal Reflux Gastroesophageal Reflux Gastrointestinal Diseases Infant, Newborn, Diseases Infantile Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

1 month–5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's City Clinical Hospital named after Bashlyaeva, Healthcare department of Moscow city, Moscow, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactobacillus reuteri

Dietary Supplement

Lactobacillus Reuteri NCIMB 30351

Other names: BioAmicus Lactobacillus drops

Placebo

Dietary Supplement

Sunflower oil

Primary outcomes

  1. Change in the number of infantile colics

    Time frame: 25 days from the start of treatment

    Infantile colics are defined according to IV Rome criteria

Secondary outcomes

  1. Change in the number of constipations

    Time frame: 25 days from the start of treatment

    Constipation is defined according to IV Rome criteria

  2. Change in the number of diarrhea cases

    Time frame: 25 days from the start of treatment

    Diarrhea is defined according to IV Rome criteria

  3. Change in the number of gastroesophageal reflux (posseting) cases

    Time frame: 25 days from the start of treatment

    Gastroesophageal reflux is defined according to IV Rome criteria

  4. Presence of skin symptoms of food allergy

    Time frame: 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

  5. Change in 16S RNA sequencing

    Time frame: 25 days from the start of treatment

    16S RNA in stool

  6. Change in concentrations of stool carbohydrates

    Time frame: 25 days from the start of treatment

    Carbohydrates concentrations will be measured in stool filtrate

  7. Change in concentrations in stool filtrate of volatile fatty acids

    Time frame: 25 days from the start of treatment

    Following volatile fatty acids concentrations will be assessed: acetic, propionic, butyric, valeric, caproic and their isomers

Sponsors and collaborators

Lead sponsor

NovoNatum Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2020
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.