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Recruiting
NCT05685030
Probiotics Strains for Infant Colic
Conditions: Colic
Sex: All
Ages: 17 Days – 23 Days
Healthy volunteers: 1
Phase: PHASE2
Enrollment: 180
Sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Location: Brazil
Summary
Interest in the use of probiotics as a potential treatment to reduce crying in babies with colic has increased lately.
Recent studies have reported that the gut microbiota in infants with colic is characterized by lower proportions of Lactobacilli and Bifidobacteria and higher proportions of opportunistic proteobacteria (such as Escherichia coli, Enterobacter aerogenes and Klebsiella spp.) in comparison with the control babies.Therefore, based on data in the literature, it is understood that there is evidence of the effectiveness of using probiotics, either alone or in the form of a blend, to alleviate the symptoms of infantile colic.
Eligibility Criteria
Inclusion Criteria:Age 20 days ± 3 days.Informed consent form signed by parentsBoth genderAvailability to complete scales daily and answer phone calls and/or text messages.Exclusion Criteria:Birth weight <2500 g;current intake of antibiotics, prebiotics, or probiotics by the baby or mother;Children with known moderate or severe disease of any system (neural, skeletal, muscular, cutaneous, gastrointestinal, respiratory, genital, urinary, immune),parental difficulty in understanding study requirements as judged by physician.
Source: ClinicalTrials.gov (NCT05685030). StuddyBuddy aggregates publicly available trial information.