An interventional study of Lactobacillus Reuteri and Placebo in Infantile Colic, Constipation and Infantile Diarrhea, sponsored by NovoNatum Ltd. Completed at 2 sites in Russian Federation. Open to participants aged 1 Month to 5 Months. Per ClinicalTrials.gov, last updated 2023-05-12.
Sponsored by NovoNatum Ltd · Not applicable, Interventional, and Treatment
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 90 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →NovoNatum Ltd is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: Lactobacillus Reuteri
Dietary Supplement: Placebo
Lactobacillus Reuteri NCIMB 30351
Also known as: BioAmicus Lactobacillus drops
Sunflower oil
Change in the number of infantile colics
Infantile colics are defined according to IV Rome criteria
Time frame: 25 days from the start of treatment
Change in the number of constipations
Constipation is defined according to IV Rome criteria
Time frame: 25 days from the start of treatment
Change in the number of diarrhea cases
Diarrhea is defined according to IV Rome criteria
Time frame: 25 days from the start of treatment
Change in the number of gastroesophageal reflux (posseting) cases
Gastroesophageal reflux is defined according to IV Rome criteria
Time frame: 25 days from the start of treatment
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
Time frame: 25 days from the start of treatment
Change in 16S RNA sequencing
16S RNA in stool
Time frame: 25 days from the start of treatment
Change in concentrations of stool carbohydrates
Carbohydrates concentrations will be measured in stool filtrate
Time frame: 25 days from the start of treatment
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
Time frame: 25 days from the start of treatment
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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