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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2013 by BioGaia AB
Sponsor:
Collaborators:
CRC CHI Creteil France
Association Clinique et therapeutique infantile du Val de Marne ACTIV
Robert Debré Hospital
Information provided by (Responsible Party):
BioGaia AB
ClinicalTrials.gov Identifier:
NCT01887444
First received: June 20, 2013
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Infantile Colic
Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Benefit of Using the Lactobacillus Reuteri Probiotic as a Supplement in the Treatment of Newborn Colic

Resource links provided by NLM:


Further study details as provided by BioGaia AB:

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. [ Time Frame: day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The responders rates at D14 and D21 in the probiotic group compared to the placebo group. [ Time Frame: Day 14 and day 21 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Gastrointestinal symptoms (constipation, diarrhea, flatulence) evaluated at each visit required by the protocol [ Time Frame: day 7, 14 and 21 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lactobacillus reteuri
Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic 2 x 10(8) CFU/day 21 days
Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic
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.
Placebo Comparator: Placebo
Other: Placebo
Other: Placebo
Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to the lipid emulsion without probiotics.

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01887444

Locations
France
CRC CHIC and ACTIV Not yet recruiting
Créteil, France, 94010
Contact: Camille JUNG, MD PhD    +33157022268    camille.jung@chicreteil.fr   
Principal Investigator: Marc Bellaiche, MD         
Sub-Investigator: Pediatricians members of the ACTIV association, MD         
Sponsors and Collaborators
BioGaia AB
CRC CHI Creteil France
Association Clinique et therapeutique infantile du Val de Marne ACTIV
Robert Debré Hospital
Investigators
Principal Investigator: Marc Bellaiche, MD Robert Debré Hospital
  More Information

No publications provided

Responsible Party: BioGaia AB
ClinicalTrials.gov Identifier: NCT01887444     History of Changes
Other Study ID Numbers: 2013-A00163-42
Study First Received: June 20, 2013
Last Updated: June 24, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by BioGaia AB:
Pediatric Gastroenterology
Probiotics
Lactobacillus reuteri

Additional relevant MeSH terms:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on August 21, 2014