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

NCT04262648 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-05-12

No results posted yet for this study

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.

Conditions

  • Infantile Colic
  • Constipation
  • Infantile Diarrhea
  • Gastro Esophageal Reflux

Interventions

DIETARY_SUPPLEMENT

Lactobacillus Reuteri

Lactobacillus Reuteri NCIMB 30351

DIETARY_SUPPLEMENT

Placebo

Sunflower oil

Sponsors & Collaborators

  • NovoNatum Ltd

    lead INDUSTRY

Principal Investigators

  • Oleg Tyrsin · NovoNatum CEO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
5 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2022-05-16
Completion
2022-05-16

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04262648 on ClinicalTrials.gov