Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic

SOFAR

Status: Completed

Conditions: Infantile Colic; Colic, Infantile

Treatments: Dietary Supplement: Bifidolactis Infant Placebo; Dietary Supplement: Bifidobacterium, BB-12® (Bifidolactis Infant)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03434249

PSC-DS BIGI

Details and patient eligibility

About

This is a single-center, randomized, double blind controlled study to investigate the effects of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with infantile colic.

Enrollment: 80 patients

Sex: All

Ages: Under 7 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients are included in the study if they meet all the following criteria:

• Exclusively breastfed healthy infants of both sexes, aged ≤ 7 weeks.
• Diagnosis of IC according to Rome III criteria.
• Written informed consent of the parent/tutor.

Exclusion criteria

Patients are excluded from this study if they meet any of the following criteria:

• Birth weight < 2500 g.
• Gestational age < 37 weeks.
• APGAR 5 minutes < 7.
• Formula feeding.
• Stunting/loss of weight (< 100 g/weeks from birth to the last reported weight).
• Neurological diseases.
• Known or suspected food allergy.
• Gastroesophageal reflux disease.
• Use of substances that alter gut microbiota (probiotics, prebiotics, antibiotics, gastric acidity inhibitors) in the last 2 weeks prior the enrollment.
• History of fever and/or infectious diseases in the last 2 weeks prior to enrollment.
• Ongoing systemic infections.
• History of congenital infections.
• Chronic intestinal diseases (cystic fibrosis or other forms of primitive pancreatic insufficiency)
• Primitive or secondary malformations of the gastrointestinal tract (such as esophageal atresia, intestinal atresia, short bowel syndrome, malrotation).
• Metabolic diseases.
• Genetic diseases and chromosomal abnormalities.
• Primary or secondary immunodeficiencies.
• Not sufficient reliability or presence of conditions that may result in non-compliance/adherence of the patient to the Protocol.
• Previous participation in this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Group I

Experimental group

Description:

patients who take Bifidobacterium BB-12® (Bifidolactis Infant), 6 drops a day (guaranteeing a billion of living cells) for 28 consecutive days;

Treatment:

Dietary Supplement: Bifidobacterium, BB-12® (Bifidolactis Infant)

Group II

Placebo Comparator group

Description:

patients who take Bifidolactis Infant Placebo 6 drops a day for 28 consecutive days.

Treatment:

Dietary Supplement: Bifidolactis Infant Placebo