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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04262648
Other study ID # BioAmicus-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 3, 2020
Est. completion date May 16, 2022

Study information

Verified date May 2023
Source NovoNatum Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date May 16, 2022
Est. primary completion date May 16, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Month to 5 Months
Eligibility 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 Design


Intervention

Dietary Supplement:
Lactobacillus Reuteri
Lactobacillus Reuteri NCIMB 30351
Placebo
Sunflower oil

Locations

Country Name City State
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" Moscow

Sponsors (1)

Lead Sponsor Collaborator
NovoNatum Ltd

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in the number of infantile colics Infantile colics are defined according to IV Rome criteria 25 days from the start of treatment
Secondary Change in the number of constipations Constipation is defined according to IV Rome criteria 25 days from the start of treatment
Secondary Change in the number of diarrhea cases Diarrhea is defined according to IV Rome criteria 25 days from the start of treatment
Secondary 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
Secondary 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
Secondary Change in 16S RNA sequencing 16S RNA in stool 25 days from the start of treatment
Secondary Change in concentrations of stool carbohydrates Carbohydrates concentrations will be measured in stool filtrate 25 days from the start of treatment
Secondary 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
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