Status:
COMPLETED
Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic
Lead Sponsor:
SOFAR S.p.A.
Conditions:
Infantile Colic
Colic, Infantile
Eligibility:
All Genders
Up to 7 years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 11 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2017
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03434249
Start Date
November 11 2016
End Date
November 6 2017
Last Update
January 23 2020
Active Locations (1)
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1
Dipartimento di Scienze Mediche Traslazionali - Sezione Pediatria - Università degli Studi di napoli "Federico II"
Napoli, Italy, 80131