NCT03467334

Brief Summary

This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B. breve CECT7263 (2x10E8 CFU/day) one dose per day, group 2 will receive B. breve CECT7263 (1x10E8 CFU/day) and L. fermentum CECT5716 (1x10E8 CFU/day) in one dose per day, group 3 (control group) will receive simethicone 20 mg 4 times a day.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 31, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

February 8, 2018

Last Update Submit

July 22, 2019

Conditions

Infant Colic

Keywords

Infant colicBifidobacterium breveLactobacillus fermentum

Outcome Measures

Primary Outcomes (1)

  • Crying time

    Crying time in minutes per day

    4 weeks

Secondary Outcomes (3)

  • Responders to treatment on weeks 1, 2, 3 and 4

    4 weeks

  • Gut microbiota

    4 weeks

  • Stool carbohydrates

    4 weeks

Study Arms (3)

B. breve

EXPERIMENTAL

Group that will receive B. breve CECT7263 one dose per day in a capsule to open and suspend the powder in infant milk or water.

Dietary Supplement: B. breve

B. breve plus L. fermentum

EXPERIMENTAL

Group that will receive B. breve CECT7263 and L. fermentum CECT5716 in one dose per day in a capsule to open and suspend the powder in infant milk or water.

Dietary Supplement: B. breve plus L. fermentum

Simethicone 20 mg

ACTIVE COMPARATOR

Control group that will receive simethicone 4 times (10 drops) a day.

Drug: Simethicone 20 MG

Interventions

B. breveDIETARY_SUPPLEMENT

Bifidobacterium probiotic strain at 1E+08 cfu/day

B. breve
B. breve plus L. fermentumDIETARY_SUPPLEMENT

Probiotic combination at 2E+08 cfu/day

B. breve plus L. fermentum
Simethicone 20 MGDRUG

Standard treatment for infant colic

Simethicone 20 mg

Eligibility Criteria

Age3 Weeks - 12 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants from 3 to 12 weeks of age
  • Born at least at week 34
  • Birth weight equal to or greater than 2000 grams
  • Fulfill the criteria of Rome III
  • Informed consent signed by parents or guardians

You may not qualify if:

  • Failure to thrive
  • Antibiotic treatment less than 2 weeks before the study or during the study
  • Take probiotics as a treatment, different from the one that could contain the powdered infant formula
  • Abandon breastfeeding and switch to infant formula
  • Failure to comply with the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio Andaluz de Salud

Granada, 10012, Spain

Location

MeSH Terms

Conditions

Colic

Interventions

Simethicone

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

DimethylpolysiloxanesSiliconesSiloxanesOrganosilicon CompoundsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • José Maldonado, MD, PhD

    Specialist in Pediatrics of the Medical-Surgical UGC of Infancy of the University Hospital Complex of Granada (Spain)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The control group is the usual treatment that is administered differently (oral drops, 4 times a day) to the 2 research treatments (powder, 1 time a day).
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of the R & D Department

Study Record Dates

First Submitted

February 8, 2018

First Posted

March 16, 2018

Study Start

May 31, 2017

Primary Completion

June 15, 2019

Study Completion

June 15, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

ES(1)