NCT02215304

Brief Summary

Study to evaluate the safety and tolerance of three probiotic bacteria intake by healthy infants. Participants are divided at random and unknown to the researchers, in four groups, three of which receive one of three probiotic bacteria while the fourth group receives placebo product.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 14, 2016

Status Verified

December 1, 2016

Enrollment Period

1.1 years

First QC Date

August 11, 2014

Last Update Submit

December 13, 2016

Conditions

Body WeightBody HeightHead Circumference

Keywords

Dietary supplementationProbioticsSafety/EfficiencyHealthy infants

Outcome Measures

Primary Outcomes (4)

  • Safety and tolerance will be evaluated according to infant growth (weight, height and head circumference)

    growth will be evaluated considering weight, height and head circumference, at four different time points during study: 1st measure will be at screening visit (visit 1/week 0), 2nd measure will be after the run-in period and before starting intervention (visit 2/ week 2), 3rd measure will be after the eight weeks of intervention (visit 3/ week 10) and the 4th measure will be two weeks later (visit 4/week 12).

    12 weeks

  • Adverse Event and/or Serious Adverse Event

    Adverse Event and/or Serious Adverse Event will be recorded daily by parents and notified to investigator within 24hrs., in particular gastro-intestinal symptoms, fever and rashes.

    10 weeks

  • Fecal characteristics

    Fecal characteristics (stool frequency, stool consistency, stool amount and stool color) will be recorded daily by parents according to the "Amsterdam scale" and notified weekly to investigators.

    10 weeks

  • Use of medication

    Medication used (antibiotics, etc) will be recorded daily by parents and notified weekly to investigators.

    12 weeks

Secondary Outcomes (4)

  • Urine concentration of D-lactic acid.

    12 weeks

  • Changes in sleep and crying patterns

    10 weeks

  • Immune compounds in fecal samples

    8 weeks

  • Composition of fecal microbiota

    8 weeks

Study Arms (4)

Bifidobacterium longum R0033

ACTIVE COMPARATOR

Bifidobacterium longum ssp infantis R0033, 3\*10E9 colony forming units (CFU) in 1 sachet per day to be diluted in 10 mL water by mouth for eight weeks

Dietary Supplement: Bifidobacterium longum ssp infantis R0033

Lactobacillus helveticus R0052

ACTIVE COMPARATOR

Lactobacillus helveticus R0052, 3\*10E9 colony forming units (CFU) in 1 sachet per day to be diluted in 10 mL water by mouth for eight weeks

Dietary Supplement: Lactobacillus helveticus R0052

Bifidobacterium bifidum R0071

ACTIVE COMPARATOR

Bifidobacterium bifidum R0071, 3\*10E9 colony forming units (CFU) in 1 sachet per day to be diluted in 10 mL water by mouth for eight weeks

Dietary Supplement: Bifidobacterium bifidum R0071

Placebo

PLACEBO COMPARATOR

potato starch 1 sachet per day to be diluted in 10 mL water by mouth for eight weeks

Dietary Supplement: Placebo

Interventions

Bifidobacterium longum ssp infantis R0033DIETARY_SUPPLEMENT

12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time. During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3\*10E9 colony forming units (CFU)

Bifidobacterium longum R0033
Lactobacillus helveticus R0052DIETARY_SUPPLEMENT

12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time. During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3\*10E9 colony forming units (CFU)

Lactobacillus helveticus R0052
Bifidobacterium bifidum R0071DIETARY_SUPPLEMENT

12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time. During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3\*10E9 colony forming units (CFU)

Bifidobacterium bifidum R0071
PlaceboDIETARY_SUPPLEMENT

12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time. During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3\*10E9 colony forming units (CFU)

Placebo

Eligibility Criteria

Age3 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy term infants between 3-12 months old
  • Written informed consent from at least one parent or the legal tutor.

You may not qualify if:

  • Short bowel syndrome or any GI surgery.
  • Impaired intestinal epithelial barrier (e.g. diarrheal illness, intestinal inflammation).
  • Metabolic disorders (diabetes, lactose intolerance).
  • Immunodeficiency.
  • Heart failure and cardiac medical history (e.g. artificial heart valve, medical history of infectious endocarditis, cardiac malformation, rheumatic fever).
  • Investigator's uncertainty about the willingness or ability of the infant's parents to comply with the protocol requirements.
  • Participation in any other clinical trial within two weeks prior to entry into the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Body Weight

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Felix Omeñaca, MD, PhD

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 13, 2014

Study Start

June 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 14, 2016

Record last verified: 2016-12

Locations

ES(1)