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

Constipation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262648
• Other study ID #: BioAmicus-001
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Colic
• Constipation
• Diarrhea
• Diarrhea, Infantile
• Food Hypersensitivity
• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• Infantile Colic
• Infantile Diarrhea

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