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Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic (PROBIOC)

Primary Purpose

Infantile Colic

Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Lactobacillus reuteri DSM17938 probiotic
Placebo
Sponsored by
BioGaia AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infantile Colic focused on measuring Pediatric Gastroenterology, Probiotics, Lactobacillus reuteri

Eligibility Criteria

29 Days - 3 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Exclusively breastfed Infants
  2. Infant aged of 29 days to 3 months
  3. With a diagnosis of infantile colic as defined by the Rome III criteria
  4. Birth at term and eutrophic (weight, height, head circumference)
  5. Apgar score> 7 at 5 minutes
  6. Consent to the study signed by the two parents.
  7. Availability during the study period

Exclusion Criteria:

  1. Associated severe chronic disease
  2. Acute infectious disease
  3. Personal or family first degree history of allergy to milk proteins
  4. Several infants of the same family from a multiple pregnancy
  5. Infants who received antibiotics one week prior to randomization
  6. Infants who received probiotics one week prior to randomization
  7. Mother who received antibiotics 1 week before randomization
  8. Regular consumption of probiotics by the mother 1 week before randomization
  9. Infants-included in another clinical study
  10. Lack of insurance coverage by the french social security
  11. Non exclusively breastfed infants

Sites / Locations

  • CRC CHIC and ACTIV

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactobacillus reteuri

Placebo

Arm Description

Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic 2 x 10(8) CFU/day 21 days

Other: Placebo

Outcomes

Primary Outcome Measures

The responder rate (infants for whom daily crying time decreases by 50% compared to baseline, D0) at D7 in the probiotic group compared to placebo. The daily crying time will be sound recorded during 24 hours at D0 and D7.and expressed in minutes.

Secondary Outcome Measures

The responders rates at D14 and D21 in the probiotic group compared to the placebo group.

Full Information

First Posted
June 20, 2013
Last Updated
February 2, 2021
Sponsor
BioGaia AB
Collaborators
CRC CHI Creteil France, Association Clinique Thérapeutique Infantile du val de Marne, Hopital Universitaire Robert-Debre
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1. Study Identification

Unique Protocol Identification Number
NCT01887444
Brief Title
Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic
Acronym
PROBIOC
Official Title
The Benefit of Using the Lactobacillus Reuteri Probiotic as a Supplement in the Treatment of Newborn Colic
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Never started
Study Start Date
October 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioGaia AB
Collaborators
CRC CHI Creteil France, Association Clinique Thérapeutique Infantile du val de Marne, Hopital Universitaire Robert-Debre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time >50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups. The average daily crying time as well as the associated digestive symptoms will also be analyzed.
Detailed Description
NOTE: The study never started.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic
Keywords
Pediatric Gastroenterology, Probiotics, Lactobacillus reuteri

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus reteuri
Arm Type
Experimental
Arm Description
Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic 2 x 10(8) CFU/day 21 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Other: Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri DSM17938 probiotic
Intervention Description
Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to 2.108 CFU Lactobacillus reuteri living DSM17938. The probiotic is contained in a lipid emulsion.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to the lipid emulsion without probiotics.
Primary Outcome Measure Information:
Title
The responder rate (infants for whom daily crying time decreases by 50% compared to baseline, D0) at D7 in the probiotic group compared to placebo. The daily crying time will be sound recorded during 24 hours at D0 and D7.and expressed in minutes.
Time Frame
day 7
Secondary Outcome Measure Information:
Title
The responders rates at D14 and D21 in the probiotic group compared to the placebo group.
Time Frame
Day 14 and day 21
Other Pre-specified Outcome Measures:
Title
The average duration of crying in the probiotic group compared with the placebo group at D7, D14 and D21.
Time Frame
Day 7, 14 and 21
Title
Gastrointestinal symptoms (constipation, diarrhea, flatulence) evaluated at each visit required by the protocol
Time Frame
day 7, 14 and 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
29 Days
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Exclusively breastfed Infants Infant aged of 29 days to 3 months With a diagnosis of infantile colic as defined by the Rome III criteria Birth at term and eutrophic (weight, height, head circumference) Apgar score> 7 at 5 minutes Consent to the study signed by the two parents. Availability during the study period Exclusion Criteria: Associated severe chronic disease Acute infectious disease Personal or family first degree history of allergy to milk proteins Several infants of the same family from a multiple pregnancy Infants who received antibiotics one week prior to randomization Infants who received probiotics one week prior to randomization Mother who received antibiotics 1 week before randomization Regular consumption of probiotics by the mother 1 week before randomization Infants-included in another clinical study Lack of insurance coverage by the french social security Non exclusively breastfed infants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Bellaiche, MD
Organizational Affiliation
Hopital Universitaire Robert-Debre
Official's Role
Principal Investigator
Facility Information:
Facility Name
CRC CHIC and ACTIV
City
Créteil
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

Learn more about this trial

Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic

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