Clinical trial NCT03434249: Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic
Official title: Studio Clinico Randomizzato Per Valutare l'Efficacia Del Bifidobacterium BB-12® Nel Trattamento Delle Coliche Infantili
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infantile Colic
Colic, Infantile
Keywords: Bifidobacterium
Lead sponsor: SOFAR S.p.A.
Sponsor class: INDUSTRY
First posted: 2018-02-15
Enrollment: 80
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized double blind placebo controlled clinical trial
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Number of Participants With >=50% Reduction in Mean Weekly Crying Duration
timeFrame: at 28 days from the baseline (Visit T5)
Secondary outcomes:
measure: Number of Crying Episodes
timeFrame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
measure: Infectious Diseases Incidence
timeFrame: at each visit, for 5 weeks starting from the enrollment in the study (Visit T0, T1, T2, T3, T4 and T5)
measure: Bowel Evacuation - Stool Frequency
timeFrame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
measure: Bowel Evacuation - Stool Consistency
timeFrame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
measure: Infant's Mood
timeFrame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
measure: Infant's Sleep
timeFrame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
measure: Infant's Temper
timeFrame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
measure: Infant's Feeding
timeFrame: at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)
measure: Calprotectin
timeFrame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
measure: Beta-defensin Type 2
timeFrame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
measure: LL37 Peptide
timeFrame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
measure: Short Chain Fatty Acids - Butyrate
timeFrame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
measure: Secretory Immunoglobulin A (SIgA)
timeFrame: at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Dipartimento di Scienze Mediche Traslazionali - Sezione Pediatria - Università degli Studi di napoli "Federico II"
Study officials:
affiliation: Federico II University
name: Roberto Berni Canani, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hyman PE, Milla PJ, Benninga MA, Davidson GP, Fleisher DF, Taminiau J. Childhood functional gastrointestinal disorders: neonate/toddler. Gastroenterology. 2006 Apr;130(5):1519-26. doi: 10.1053/j.gastro.2005.11.065.
citation: Szajewska H, Gyrczuk E, Horvath A. Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial. J Pediatr. 2013 Feb;162(2):257-62. doi: 10.1016/j.jpeds.2012.08.004. Epub 2012 Sep 14.
citation: Kabeerdoss J, Devi RS, Mary RR, Prabhavathi D, Vidya R, Mechenro J, Mahendri NV, Pugazhendhi S, Ramakrishna BS. Effect of yoghurt containing Bifidobacterium lactis Bb12(R) on faecal excretion of secretory immunoglobulin A and human beta-defensin 2 in healthy adult volunteers. Nutr J. 2011 Dec 23;10:138. doi: 10.1186/1475-2891-10-138.
citation: Mohan R, Koebnick C, Schildt J, Mueller M, Radke M, Blaut M. Effects of Bifidobacterium lactis Bb12 supplementation on body weight, fecal pH, acetate, lactate, calprotectin, and IgA in preterm infants. Pediatr Res. 2008 Oct;64(4):418-22. doi: 10.1203/PDR.0b013e318181b7fa.
citation: Mohan R, Koebnick C, Schildt J, Schmidt S, Mueller M, Possner M, Radke M, Blaut M. Effects of Bifidobacterium lactis Bb12 supplementation on intestinal microbiota of preterm infants: a double-blind, placebo-controlled, randomized study. J Clin Microbiol. 2006 Nov;44(11):4025-31. doi: 10.1128/JCM.00767-06. Epub 2006 Sep 13.
citation: Savino F, Cordisco L, Tarasco V, Calabrese R, Palumeri E, Matteuzzi D. Molecular identification of coliform bacteria from colicky breastfed infants. Acta Paediatr. 2009 Oct;98(10):1582-8. doi: 10.1111/j.1651-2227.2009.01419.x. Epub 2009 Jul 9.
citation: Hall B, Chesters J, Robinson A. Infantile colic: a systematic review of medical and conventional therapies. J Paediatr Child Health. 2012 Feb;48(2):128-37. doi: 10.1111/j.1440-1754.2011.02061.x. Epub 2011 Apr 7.
citation: Savino F, Bailo E, Oggero R, Tullio V, Roana J, Carlone N, Cuffini AM, Silvestro L. Bacterial counts of intestinal Lactobacillus species in infants with colic. Pediatr Allergy Immunol. 2005 Feb;16(1):72-5. doi: 10.1111/j.1399-3038.2005.00207.x.
citation: Savino F, Cresi F, Pautasso S, Palumeri E, Tullio V, Roana J, Silvestro L, Oggero R. Intestinal microflora in breastfed colicky and non-colicky infants. Acta Paediatr. 2004 Jun;93(6):825-9.
citation: Gupta SK. Is colic a gastrointestinal disorder? Curr Opin Pediatr. 2002 Oct;14(5):588-92. doi: 10.1097/00008480-200210000-00005.
citation: Lucassen PL, Assendelft WJ, van Eijk JT, Gubbels JW, Douwes AC, van Geldrop WJ. Systematic review of the occurrence of infantile colic in the community. Arch Dis Child. 2001 May;84(5):398-403. doi: 10.1136/adc.84.5.398.
citation: BRAZELTON TB. Crying in infancy. Pediatrics. 1962 Apr;29:579-88. No abstract available.
citation: Iacovou M, Ralston RA, Muir J, Walker KZ, Truby H. Dietary management of infantile colic: a systematic review. Matern Child Health J. 2012 Aug;16(6):1319-31. doi: 10.1007/s10995-011-0842-5.