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Clinical Trial of L. Reuteri in Infantile Colic 2017 (Colic2017)

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ClinicalTrials.gov Identifier: NCT03360253
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
BioGaia AB
Information provided by (Responsible Party):
Pedro Gutierrez Castrellon, Innovacion y Desarrollo de Estrategias en Salud

Brief Summary:
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic, feed with human milk (30% sample) or infant formula (70%)

Condition or disease Intervention/treatment Phase
Infantile Colic Dietary Supplement: L. reuteri DSM 17938 in drops Other: Placebo Not Applicable

Detailed Description:
RCT to evaluate the safety and efficacy of Lactobacillus reuteri DSM 17938 administrated for 21 days to significantly reduce the duration of crying time and fussines in infants from 15days to 4 months of age with colic. 66 infants feed with human milk and 180 infant feed with infant formula will be included. As primary outcome we will measure the difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary. Secondary/exploratory outcomes will be average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group; average of crying and fussing time on day 7, 14 and average from days 19 to 21 after randomization (Barr diary) of L. reuteri groups vs placebo group; responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study; QoL (PedsQL-2.0-Family Impact Module AU2.0 spa-MX) changes from baseline to days 7, 14 and 21 and Edinburg postnatal depression scale for mothers from baseline to days 7, 14 and 21

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial, double blind allocation concealment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Children allocated on different arms will receive drops of probiotics or placebo. Both product are identical in appearence and flavor
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Lactobacillus Reuteri DSM 17938 to Reduce the Crying Time in Infants With Colic: Randomised Controlled Trial With Two Parallel Arms. Version 3.3. Nov,11th,2016
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : January 30, 2019

Arm Intervention/treatment
Experimental: HMilkProb
L. reuteri DSM 17938 in drops will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle. In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together to give the product the correct rheological properties
Dietary Supplement: L. reuteri DSM 17938 in drops
L. reuteri DSM 17938 will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle
Placebo Comparator: HMilkPlacebo
The placebo consists of an identical formulation except that the L. reuteri is not present
Other: Placebo
The placebo consists of an identical formulation except that the L. reuteri is not present
Experimental: IFormProb
L. reuteri DSM 17938 in drops will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle. In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together to give the product the correct rheological properties
Dietary Supplement: L. reuteri DSM 17938 in drops
L. reuteri DSM 17938 will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle
Placebo Comparator: IFormPlacebo
The placebo consists of an identical formulation except that the L. reuteri is not present
Other: Placebo
The placebo consists of an identical formulation except that the L. reuteri is not present



Primary Outcome Measures :
  1. Crying time [ Time Frame: 21 days ]

    Difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary.

    Difference between children receiving L. reuteri DSM 17938, 108 CFU vs children receiving placebo regarding average daily crying duration (minutes per day, from average of crying from days 19 to 21 after randomization), measured by Barr diary.



Secondary Outcome Measures :
  1. Preliminary crying time [ Time Frame: Day 7 and 14 ]
    Average of crying time on day 7 and 14 (Barr diary) of L. reuteri groups vs placebo group

  2. Crying and fussing [ Time Frame: 7,14 and 21 days ]
    Average of crying and fussing time on day 7, 14 and average from days 19 to 21 after randomization (Barr diary) of L. reuteri groups vs placebo group

  3. Total responders [ Time Frame: 7,14 and 21 days ]
    Responders percentage on day 7, 14 and 21, decrease in daily average crying time of 50% during the study

  4. Impact on Quality of Life [ Time Frame: 7, 14 and 21 days ]
    Impact on Quality of Life measured by PedsQL-2.0-Family Impact Module AU2.0 spa-MX. Changes from baseline to days 7, 14 and 21

  5. Maternal depression [ Time Frame: 7, 14 and 21 days ]
    Maternal depression evaluated with Edinburgh Postnatal Depression Scale (EPDS)



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Ages Eligible for Study:   up to 9 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Younger than 10 weeks of age
  • Full term infant (37-42 weeks gestational age)
  • Birth weight ≥ 2,500g
  • Apgar score ≥ 7 at 5 minutes
  • Infantile colic diagnosed according to modified Wessel's criteria (crying more than 180 min/day during 3 days for at least a week prior to enrolment)
  • Parental motivation to postpone changes in the infant feeding mode, unless necessary
  • Stated availability throughout the study period
  • Parent(s) willingness and ability to fill out charts and questionnaires
  • Signed informed consent

Exclusion Criteria:

  • Failure to thrive
  • Chronic illness or major medical problem
  • Gastrointestinal disease
  • Use of any antibiotic 2 weeks before Day 1 in the study. This applies also to lactating mothers whose infants participate in the trial
  • Use of supplements/eaten foods that contain Lactobacillus reuteri, 2 weeks before Day 1
  • Use of proton pump inhibitors in the week (7 days) prior to enrolment
  • If breastfeeding, use of probiotic by the mother in the week (7 days) prior to enrolment and throughout the study period
  • Use of infant formula with hydrolysed protein
  • Infant receiving solid foods (such as cereals, mashed fruits or vegetable purée)
  • Change of feeding mode planned by parents during the study period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360253


Contacts
Contact: Patricia Vidal, MSc 525540003000 ext 3717 vidalv.patricia@gmail.com
Contact: Monica Rodriguez, MSc 525540003000 ext 3717 mon.medley@gmail.com

Locations
Mexico
Hospital General Dr. Manuel Gea Gonzalez Recruiting
Mexico city, Tlalpan, Mexico, 14080
Contact: Patricia Vidal, MSc    525540003000 ext 3717    vidalv.patricia@gmail.com   
Contact: Monica Rodriguez, MSc    525540003000 ext 3717    mon.medley@gmail.com   
Sponsors and Collaborators
Innovacion y Desarrollo de Estrategias en Salud
BioGaia AB
Investigators
Principal Investigator: Pedro Gutierrez-Castrellon, DSc Hospital General Dr. Manuel Gea Gonzalez

Responsible Party: Pedro Gutierrez Castrellon, MD, MSc, DSc, Innovacion y Desarrollo de Estrategias en Salud
ClinicalTrials.gov Identifier: NCT03360253     History of Changes
Other Study ID Numbers: Colic2017
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Colic
Infant, Newborn, Diseases