Prevention of Colic With the Probiotic Lactobacillus Reuteri

Colic Clinical Trial

Official title:

Prevention of Colic With the Probiotic Lactobacillus Reuteri in Mexican Infants: Randomized, Double-blind Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02577133
• Other study ID #: HGNAE-04
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: October 14, 2015
• Last updated: October 15, 2015
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: October 2015
• Source: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
• Contact: Héctor Javier Varona Bobadilla, Dr.
• Phone: (52) 55 56 24 65 00
• Email: kavel_555[@]hotmail.com
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Methods:

This study is planned for October 2015 to October 2016 aiming newborns born population in Naval Hospital

Inclusion:

• 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.

Exclusion:

• Administration of antibiotics to the mother for a week before the birth of the newborn.

• Administration of probiotics newborn before inclusion or consumption by the mother during these last two trimesters.

• Medication Management newborn different routine prescribed at birth.

Elimination

• Loss of monitoring

• Abandonment by parents

• Diagnosis of allergy to cow's milk protein (confirmed by resolution of symptoms after switching to Formula hypo allergenic or free feeding cow's milk by the mother in breastfed children).

• Diagnosis of structural alterations or gastrointestinal illness to explain the symptoms of colic in the following months after the inclusion

Interventions:

The patients enrolled will receive probiotics (1000000000 CFU per day) or placebo every days for 28 days

Weekly, each patient will be called twice to interrogate the number of events colic as well as the different variables under study

After birth, on 15, 30, 45 and 60 of life will be cited for clinical examination and review and weight dropper bottle of probiotic

• Principal: Number of events or inconsolable crying

• Secondary: Average or evacuations / day Average or regurgitation / day Drugs to decrease excessive crying Medical reviews for excessive crying Changes feeding for excessive crying Level of satisfaction with the care of the newborn (numerical scale from 0: the worst possible, 10: completely satisfied)

• Universal variables

Weight:

Size:

Gender Weeks gestation Type of birth Feeding of formula / breast-

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 478
• Est. completion date: October 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Week

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Administration of antibiotics to the mother for a week before the birth of the newborn.

• Administration of probiotics newborn before inclusion or consumption by the mother during these last two trimesters.

• Medication Management newborn different routine prescribed at birth.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colic

Intervention

Dietary Supplement:
• Lactobacillus reuteri DSM 17938
Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days
• Placebo
The placebo consisted of an identical bottle with distilled water

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Naval de Alta Especialidad - Escuela Medico Naval

References & Publications (23)

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Cohen GM, Albertini LW. Colic. Pediatr Rev. 2012 Jul;33(7):332-3; discussion 333. doi: 10.1542/pir.33-7-332. — View Citation

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

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

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event number of colic		3 months	Yes