Infant regurgitation is the most common functional gastrointestinal disorder (FGID) worldwide and causes parental concern with relevant direct and indirect costs for families and the healthcare system. Bifidobacterium animalis subsp. lactis BB-12 (BB-12) is a well-known studied probiotic with evidence in managing another FGID, such as infantile colic. This real-life study evaluated the efficacy of BB-12 in decreasing functional regurgitation symptoms when supplemented in formula-fed infants (partial or absolute). In 17 outpatient services of the Italian National Pediatric Health Care System, formula-fed infants with persisting regurgitation symptoms were randomly (1:1) allocated to receive six drops (1x109 CFU of BB 12; ABINAT12®) daily (Group A) or any probiotic (Group B) for two months. Regurgitation symptoms were evaluated through the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R), performed at the baseline visit (T0) and after 30 (T1) and 60 (T2) days. A positive response was defined as a total score > 16. Nine hundred and sixty infants were randomly allocated to receive BB12 (Group A; 499 subjects) or any probiotic (Group B; 461 subjects). At baseline, 25.8% in Group A and 31.7% in Group B responded positively to the I-GERQ-R questionnaire. At T1, 16% in Group A and 45.8% in Group B (p<0.001) had a positive I-GERQ-R. At T2, 14.7% in Group A and 50.7% in Group B (p<0.001) had a positive I-GEQ-R. Consistently, the total scores significantly decreased in Group A. In conclusion, this real-life study demonstrated that a two-month BB-12 supplementation (ABINAT12®) significantly reduced regurgitation prevalence and severity in formula-fed infants.
Bifidobacterium animalis subsp. lactis BB-12 and infant regurgitation: a real-life experience
Salvatore S.;
2022-01-01
Abstract
Infant regurgitation is the most common functional gastrointestinal disorder (FGID) worldwide and causes parental concern with relevant direct and indirect costs for families and the healthcare system. Bifidobacterium animalis subsp. lactis BB-12 (BB-12) is a well-known studied probiotic with evidence in managing another FGID, such as infantile colic. This real-life study evaluated the efficacy of BB-12 in decreasing functional regurgitation symptoms when supplemented in formula-fed infants (partial or absolute). In 17 outpatient services of the Italian National Pediatric Health Care System, formula-fed infants with persisting regurgitation symptoms were randomly (1:1) allocated to receive six drops (1x109 CFU of BB 12; ABINAT12®) daily (Group A) or any probiotic (Group B) for two months. Regurgitation symptoms were evaluated through the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R), performed at the baseline visit (T0) and after 30 (T1) and 60 (T2) days. A positive response was defined as a total score > 16. Nine hundred and sixty infants were randomly allocated to receive BB12 (Group A; 499 subjects) or any probiotic (Group B; 461 subjects). At baseline, 25.8% in Group A and 31.7% in Group B responded positively to the I-GERQ-R questionnaire. At T1, 16% in Group A and 45.8% in Group B (p<0.001) had a positive I-GERQ-R. At T2, 14.7% in Group A and 50.7% in Group B (p<0.001) had a positive I-GEQ-R. Consistently, the total scores significantly decreased in Group A. In conclusion, this real-life study demonstrated that a two-month BB-12 supplementation (ABINAT12®) significantly reduced regurgitation prevalence and severity in formula-fed infants.
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