NCT04262648

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: NovoNatum Ltd · Industry
• Sex: All
• Age: 1 Month – 5 Months
• Healthy volunteers: Not accepted

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

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus Reuteri	Lactobacillus Reuteri NCIMB 30351
DIETARY_SUPPLEMENT	Placebo	Sunflower oil

Timeline

• Start date: 2020-03-03
• Primary completion: 2022-05-16
• Completion: 2022-05-16
• First posted: 2020-02-10
• Last updated: 2023-05-12

Locations

2 sites across 1 country: Russia