NCT04262648

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
22 days until next milestone

Study Start

First participant enrolled

March 3, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2022

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

2.2 years

First QC Date

February 7, 2020

Last Update Submit

May 10, 2023

Conditions

Infantile ColicConstipationInfantile DiarrheaGastro Esophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • Change in the number of infantile colics

    Infantile colics are defined according to IV Rome criteria

    25 days from the start of treatment

Secondary Outcomes (7)

  • Change in the number of constipations

    25 days from the start of treatment

  • Change in the number of diarrhea cases

    25 days from the start of treatment

  • Change in the number of gastroesophageal reflux (posseting) cases

    25 days from the start of treatment

  • Presence of skin symptoms of food allergy

    25 days from the start of treatment

  • Change in 16S RNA sequencing

    25 days from the start of treatment

  • +2 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL
Dietary Supplement: Lactobacillus Reuteri

Control

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Lactobacillus ReuteriDIETARY_SUPPLEMENT

Lactobacillus Reuteri NCIMB 30351

Also known as: BioAmicus Lactobacillus drops
Treatment
PlaceboDIETARY_SUPPLEMENT

Sunflower oil

Control

Eligibility Criteria

Age1 Month - 5 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Moscow, Russia

Location

Medical Center "St. Andrew's Hospitals - NEBOLIT"

Moscow, Russia

Location

Related Publications (1)

  • Tyrsin OY, Tyrsin DY, Nemenov DG, Ruzov AS, Odintsova VE, Koshechkin SI, D Amico L. Effect of Lactobacillus reuteri NCIMB 30351 drops on symptoms of infantile functional gastrointestinal disorders and gut microbiota in early infants: Results from a randomized, placebo-controlled clinical trial. Eur J Pediatr. 2024 May;183(5):2311-2324. doi: 10.1007/s00431-024-05473-y. Epub 2024 Mar 1.

    PMID: 38427038DERIVED

MeSH Terms

Conditions

ColicConstipationDiarrhea, InfantileGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsDiarrheaEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Oleg Tyrsin

    NovoNatum CEO

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 10, 2020

Study Start

March 3, 2020

Primary Completion

May 16, 2022

Study Completion

May 16, 2022

Last Updated

May 12, 2023

Record last verified: 2023-05

Locations

RU(2)