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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-03

Study Completion Date

2022-05-16

Brief Summary

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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.

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Detailed Description

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Conditions

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Infantile Colic Constipation Infantile Diarrhea Gastro Esophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment

Group Type EXPERIMENTAL

Lactobacillus Reuteri

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus Reuteri NCIMB 30351

Control

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Sunflower oil

Interventions

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Lactobacillus Reuteri

Lactobacillus Reuteri NCIMB 30351

Intervention Type DIETARY_SUPPLEMENT

Placebo

Sunflower oil

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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BioAmicus Lactobacillus drops

Eligibility Criteria

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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.

Minimum Eligible Age

1 Month

Maximum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No