NEOBIFI: Clinical Trial for the Prevention and/or Reduction of the Incidence of Colics in Infants (NEOBIFI)
Colic, Infantile, Probiotic, Gut Microbiome
About this trial
This is an interventional treatment trial for Colic, Infantile focused on measuring infant colics, probiotic, gut microbiome, bifidobacterium breve, crying time
Eligibility Criteria
Inclusion Criteria:
- Only healthy babies term born
- Between 6 days and 15 days of life
- With a Birth weight between 2500 gr and 4000 gr
- With natural childbirth
Exclusion Criteria:
- Adverse reactions to the product or component of the product (allergies…)
- Antibiotic treatments
- Chronic diseases, hepatic or gastroenterological diseases
- Medical treatment for chronic diseases
- Probiotic or prebiotic therapies
Sites / Locations
- AOU Maggiore della Carità - Clinica Pediatrica - Ambulatorio di Gastroenterologia Pediatrica
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Placebo Comparator
Placebo Comparator
Active group - Breastfeeding infants
Active Group - Bottlefeeding infant
Placebo group - Breastfeeding infants
Placebo group - Bottlefeeding infants
In this Group will be enrolled only infants who are breastfed. This Group will take the active product containing 5 drops of active product (108 viable cells/strain) of Bifidobacterium breve BR03 and Bifidobacterium breve B632.
In this active Group will be enrolled only infant who are bottle-fed. This Group will take the active product containing 5 drops of active product (108 viable cells/strain) of Bifidobacterium breve BR03 and Bifidobacterium breve B632.
In this placebo Group will be enrolled only infants who are breastfed. This arm will receive a supplementation with a same product equal to the active product but without bifidobacterium inside.
In this placebo Group will be enrolled only infants who are bottlefed. This arm will receive a supplementation with a same product equal to the active product but without bifidobacterium inside.