Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk

June 28, 2017 updated by: Biosearch S.A.
A randomized double blinded controlled study including infants at the age of 1 month . Infants are assigned randomly to either infant formula supplemented with B. breve CECT7263 or L.fermentum CECT5716 (Probiotic groups), or the same formula without the probiotic strain (Control group). The primary outcome of the study is the body weight gain of infants. Secondary outcomes are incidence of infections, symptoms related with intestinal function, and fecal microbiota

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Córdoba, Spain, 14004
        • Hospital Reina Sofia
      • Granada, Spain, 10012
        • Servicio Andaluz de Salud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 weeks to 1 month (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newborn infants at term (37-42 weeks gestational age) healthy during the first month of life, for reasons unrelated to the study, abandon breastfeeding during the first month of life.
  • Signature of informed parental or guardian consent.

Exclusion Criteria:

  • Allergic to the protein in cow's milk.
  • Lactose intolerant.
  • Suffering from a serious metabolic disease.
  • They have experienced or are experiencing some severe gastrointestinal disease.
  • Receive some form of chronic medication or are receiving antibiotics at the time of capture.
  • Low expectation of compliance with the study protocol.
  • allergic to any group of antibiotics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Bifido
Infant formula containing Bifidobacterium breve CECT7263
Dietary supplement: Bifido
Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263
Active Comparator: Lfer
Infant formula containing Lactobacillus fermentum CECT5716
Dietary supplement: Lfer
Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716
Placebo Comparator: Control
Standard infant formula
Other: Control
Standard infant formula

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body weight gain
Time Frame: 12 months versus baseline
Body weight gain at 12 months (grams)
12 months versus baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length
Time Frame: 1,2,4,6,9 and 12 months of age
Length (cm)
1,2,4,6,9 and 12 months of age
Body weight
Time Frame: 1,2,4,6,9 and 12 months of age
Body weight of infants at different times (kg)
1,2,4,6,9 and 12 months of age
Incidence of infections
Time Frame: total incidence during intervention (11 months)
Events of infections diseases during intervention period (Incidence rate)
total incidence during intervention (11 months)
Bacterial load in feces
Time Frame: 1,2,4,6,9 and 12 months of age
Counts of Lactobacillus, bifidobacteria, bacteroides, clostridium (CFU/g feces)
1,2,4,6,9 and 12 months of age
Regurgitation
Time Frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Measurement by score: 1 = not at all, 2 = regurgitation of small amounts during or shortly after feeding, 3 = larger regurgitation during or shortly after feeding, 4 = minor vomiting with time-lag to prior feeding, and 5 = severe vomiting with considerable loss of fluid.
each 2 weeks until 6 months of age and monthly until 12 months of age
Fecal deposition
Time Frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Measurement by score:1 = <1 time, 2 = 1-3, 3 = 4-6, 4 = 7-10, and 5 = >10.
each 2 weeks until 6 months of age and monthly until 12 months of age
Infant colic
Time Frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Average crying hours per day during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age. Score: no crying; < 3 hours/day; 3-6 hours/day; 6-12 hours/day; > 12 hours/day
each 2 weeks until 6 months of age and monthly until 12 months of age
Flatulency
Time Frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Average of duration of flatulence episodes (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score:no flatulency; < 3 hours/day; 3-6 hours/day; 6-12 hours/day; > 12 hours/day
each 2 weeks until 6 months of age and monthly until 12 months of age
Hours of night sleep
Time Frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Average of time of night sleep (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score: < 4 hours ; 4-6 hours; 6-9 hours; 9-12 hours; > 12 hours
each 2 weeks until 6 months of age and monthly until 12 months of age
Total hours of sleep/day
Time Frame: each 2 weeks until 6 months of age and monthly until 12 months of age
Average of total time of sleep (hours per day) during the last two days of each period of measurement which is each 2 weeks until 6 months of age and monthly until 12 months of age.Measurement by the score: < 11 hours;  11-14 hours; 14-17 hours; 17-20 hours;  > 20 hours
each 2 weeks until 6 months of age and monthly until 12 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosearch S.A.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Andaluz Health Service
Maimónides Biomedical Research Institute of Córdoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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