Prevention of Colic With the Probiotic Lactobacillus Reuteri

NCT02577133 | Unknown Phase 2

• 1 other identifier: HGNAE-04
• Study Type: interventional
• Target: 478
• Locations: 0 countries
• Sites: N/A

Brief Summary

Colic is a term for inconsolable crying happened in the first months of life. Its etiology is multifactorial and caregiver and pediatrician generates among other problems: anxiety, risk of child abuse as well as economic costs. There is now enough evidence for the treatment of colic using probiotics, especially Lactobacillus reuteri. The investigators study aims to demonstrate the utility for the prevention of colic with L. reuteri and thereby avoid the problems caused by this pathology. Objective: Compare the number of events of colic among infants with oral probiotic Lactobacillus reuteri during the first month of life versus infants with placebo Study Design. Double blind, randomized, controlled, 492 neonates of 37-42 gestational age, breast or formula fed, will receive L. reuteri 5 drops (1x108 CFU) daily or placebo for 28 days. The investigators trial will be performed at Naval Hospital in Mexico City.

Conditions

Colic

Keywords

colic; probiotic; Lactobacillus reuteri; prevention

Outcome Measures

Primary Outcomes (1)

• Event number of colic

  3 months

Study Arms (2)

Lactobacillus reuteri group

ACTIVE COMPARATOR

Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days

Dietary Supplement: Lactobacillus reuteri DSM 17938

Placebo group

PLACEBO COMPARATOR

Placebo (5 drops) for 28 days

Dietary Supplement: Placebo

Interventions

Lactobacillus reuteri DSM 17938 DIETARY_SUPPLEMENT

Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days

Also known as: BioGaia

Lactobacillus reuteri group

Placebo DIETARY_SUPPLEMENT

The placebo consisted of an identical bottle with distilled water

Placebo group

Eligibility Criteria

• Age: 1 Day - 1 Week
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Term Healthy Newborns (RN) ≥38 weeks and ≤ 41 weeks of gestation.
• Appropriate weight for gestational age
• ≥than 8 Apgar at 5 minutes
• Egress at the first 24-48 hours of life of the newborn with the mother of hospital
• No congenital or physical abnormalities on physical examination at birth.
• Availability during the study period.
• Thorough understanding of the protocol by parents
• Informed Consent is signed by both parents.

You may not qualify if:

• Administration of antibiotics to the mother for a week before the birth of the newborn.
• Medication Management newborn different routine prescribed at birth.

Sponsors & Collaborators

• Hospital General Naval de Alta Especialidad - Escuela Medico Naval: lead

Related Publications (23)

• 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

• WESSEL MA, COBB JC, JACKSON EB, HARRIS GS Jr, DETWILER AC. Paroxysmal fussing in infancy, sometimes called colic. Pediatrics. 1954 Nov;14(5):421-35. No abstract available.

  PMID: 13214956 BACKGROUND

• Douglas P, Hill P. Managing infants who cry excessively in the first few months of life. BMJ. 2011 Dec 15;343:d7772. doi: 10.1136/bmj.d7772. No abstract available.

  PMID: 22174332 BACKGROUND

• E. Ortega Páeza , D. Barroso Espaderob Flashes pediátricos AEpap Cólico del lactante Rev Pediatr Aten Primaria Supl. 2013;(22):81-7

  BACKGROUND

• Wolke D, Samara M, Alvarez Wolke M. Meta-analysis of fuss/cry durations and colic prevalence across countries: Proceedings of the11th International Infant Cry Research Workshop, June, 2011, The Netherlands.

  BACKGROUND

• Cohen GM, Albertini LW. Colic. Pediatr Rev. 2012 Jul;33(7):332-3; discussion 333. doi: 10.1542/pir.33-7-332. No abstract available.

  PMID: 22753793 BACKGROUND

• Barr RG, Rotman A, Yaremko J, Leduc D, Francoeur TE. The crying of infants with colic: a controlled empirical description. Pediatrics. 1992 Jul;90(1 Pt 1):14-21.

  PMID: 1614771 BACKGROUND

• Romanello S, Spiri D, Marcuzzi E, Zanin A, Boizeau P, Riviere S, Vizeneux A, Moretti R, Carbajal R, Mercier JC, Wood C, Zuccotti GV, Crichiutti G, Alberti C, Titomanlio L. Association between childhood migraine and history of infantile colic. JAMA. 2013 Apr 17;309(15):1607-12. doi: 10.1001/jama.2013.747.

  PMID: 23592105 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

• de Weerth C, Fuentes S, Puylaert P, de Vos WM. Intestinal microbiota of infants with colic: development and specific signatures. Pediatrics. 2013 Feb;131(2):e550-8. doi: 10.1542/peds.2012-1449. Epub 2013 Jan 14.

  PMID: 23319531 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

• Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Di Prima L, Scalici C, Indinnimeo L, Averna MR, Carroccio A; Paediatric Study Group on Gastrointestinal Symptoms in Infancy. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005 Jun;37(6):432-8. doi: 10.1016/j.dld.2005.01.009. Epub 2005 Mar 2.

  PMID: 15893282 BACKGROUND

• Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.

  PMID: 16678553 BACKGROUND

• Charrois TL, Sandhu G, Vohra S. Probiotics. Pediatr Rev. 2006 Apr;27(4):137-9. doi: 10.1542/pir.27-4-137. No abstract available.

  PMID: 16581954 BACKGROUND

• http://www.biogaia.com/lactobacillus-reuter

  BACKGROUND

• Talarico TL, Casas IA, Chung TC, Dobrogosz WJ. Production and isolation of reuterin, a growth inhibitor produced by Lactobacillus reuteri. Antimicrob Agents Chemother. 1988 Dec;32(12):1854-8. doi: 10.1128/AAC.32.12.1854.

  PMID: 3245697 BACKGROUND

• Morelli L, Capurso L. FAO/WHO guidelines on probiotics: 10 years later. J Clin Gastroenterol. 2012 Oct;46 Suppl:S1-2. doi: 10.1097/MCG.0b013e318269fdd5. No abstract available.

  PMID: 22955349 BACKGROUND

• Lifschitz C. Probiotics: Implications for Paediatric Health, Nestlé Nutrition Institute, South Asia Workshop Proceedings Vol. 1, Issue 1, 2013

  BACKGROUND

• Savino F, Pelle E, Palumeri E, Oggero R, Miniero R. Lactobacillus reuteri (American Type Culture Collection Strain 55730) versus simethicone in the treatment of infantile colic: a prospective randomized study. Pediatrics. 2007 Jan;119(1):e124-30. doi: 10.1542/peds.2006-1222.

  PMID: 17200238 BACKGROUND

• Savino F, Cordisco L, Tarasco V, Palumeri E, Calabrese R, Oggero R, Roos S, Matteuzzi D. Lactobacillus reuteri DSM 17938 in infantile colic: a randomized, double-blind, placebo-controlled trial. Pediatrics. 2010 Sep;126(3):e526-33. doi: 10.1542/peds.2010-0433. Epub 2010 Aug 16.

  PMID: 20713478 BACKGROUND

• Chumpitazi BP, Shulman RJ. Five probiotic drops a day to keep infantile colic away? JAMA Pediatr. 2014 Mar;168(3):204-5. doi: 10.1001/jamapediatrics.2013.5002. No abstract available.

  PMID: 24424486 BACKGROUND

• Sung V, Collett S, de Gooyer T, Hiscock H, Tang M, Wake M. Probiotics to prevent or treat excessive infant crying: systematic review and meta-analysis. JAMA Pediatr. 2013 Dec;167(12):1150-7. doi: 10.1001/jamapediatrics.2013.2572.

  PMID: 24100440 BACKGROUND

• Indrio F, Di Mauro A, Riezzo G, Civardi E, Intini C, Corvaglia L, Ballardini E, Bisceglia M, Cinquetti M, Brazzoduro E, Del Vecchio A, Tafuri S, Francavilla R. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):228-33. doi: 10.1001/jamapediatrics.2013.4367.

  PMID: 24424513 BACKGROUND

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

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

Study Officials

• Héctor Javier Varona Bobadilla, Dr.

  Secretaria de Marina-Armada de México (Mexican Navy)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Héctor Javier Varona Bobadilla, Dr.

CONTACT

(52) 55 56 24 65 00; kavel_555@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prevention of colic with the probiotic Lactobacillus reuteri DSM 17938 in Mexican infants: randomized, double-blind study

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 16, 2015
• Study Start: October 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 16, 2015

Record last verified: 2015-10