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

NCT03434249 | Completed Results

• 1 other identifier: PSC-DS BIGI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Infantile Colic; Colic, Infantile

Keywords

Bifidobacterium

Outcome Measures

Primary Outcomes (1)

• Number of Participants With >=50% Reduction in Mean Weekly Crying Duration

  Treatment success rate was evaluated in terms of reduction of crying duration, comparing mean weekly duration of the last Week (from T4 to T5) and mean weekly duration of Week 1 (from T0 to T1). The daily number and duration of crying episodes has been collected in the 'Evaluation of crying' section of the patient diary. Weekly mean is defined as the mean of the calculated average daily durations during the selected week and is described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be computed as well. The following categories of patients has been defined: Success = patients who meet the criteria for the treatment success rate No Success = patients who do not meet the criteria for the treatment success rate Missing = patients who did not do the last visit (Visit T5 - at 28 days from baseline)

  at 28 days from the baseline (Visit T5)

Secondary Outcomes (13)

• Number of Crying Episodes

  at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5)

• Infectious Diseases Incidence

  at each visit, for 5 weeks starting from the enrollment in the study (Visit T0, T1, T2, T3, T4 and T5)

• Bowel Evacuation - Stool Frequency

  at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)

• Bowel Evacuation - Stool Consistency

  at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)

• Infant's Mood

  at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5)

Study Arms (2)

Group I

EXPERIMENTAL

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

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

Group II

PLACEBO COMPARATOR

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

Dietary Supplement: Bifidolactis Infant Placebo

Interventions

Bifidobacterium, BB-12® (Bifidolactis Infant) DIETARY_SUPPLEMENT

Group I

Bifidolactis Infant Placebo DIETARY_SUPPLEMENT

Group II

Eligibility Criteria

• Age: Up to 7 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• SOFAR S.p.A.: lead

Study Sites (1)

Dipartimento di Scienze Mediche Traslazionali - Sezione Pediatria - Università degli Studi di napoli "Federico II"

Napoli, 80131, Italy

Location

Related Publications (13)

• 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.

  PMID: 16678565 BACKGROUND

• 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.

  PMID: 22981952 BACKGROUND

• 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.

  PMID: 22196482 BACKGROUND

• 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.

  PMID: 18552710 BACKGROUND

• 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.

  PMID: 16971641 BACKGROUND

• 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.

  PMID: 19604166 BACKGROUND

• 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.

  PMID: 21470331 BACKGROUND

• 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.

  PMID: 15693915 BACKGROUND

• 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.

  PMID: 15244234 BACKGROUND

• Gupta SK. Is colic a gastrointestinal disorder? Curr Opin Pediatr. 2002 Oct;14(5):588-92. doi: 10.1097/00008480-200210000-00005.

  PMID: 12352253 BACKGROUND

• 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.

  PMID: 11316682 BACKGROUND

• BRAZELTON TB. Crying in infancy. Pediatrics. 1962 Apr;29:579-88. No abstract available.

  PMID: 13872677 BACKGROUND

• 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.

  PMID: 21710185 BACKGROUND

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: LAURA PATRUCCO
• Organization: SOFAR S.p.A

laura.patrucco@sofarfarm.it

+390202 909 362291

Study Officials

• Roberto Berni Canani, Prof.

  Federico II University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a prospective randomized double blind placebo controlled clinical trial

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 15, 2018
• Study Start: November 11, 2016
• Primary Completion: November 6, 2017
• Study Completion: November 6, 2017
• Last Updated: January 23, 2020
• Results First Posted: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)