Growth, Safety and Efficacy of a Probiotic Supplement (Clara)

March 22, 2023 updated by: Société des Produits Nestlé (SPN)

Growth, Safety and Efficacy of a Probiotic Supplement: a Double-blind, Randomized, Placebo-controlled Trial

The primary objective of the study is to demonstrate the safety of a daily high dose of a probiotic supplement by comparing the growth (weight gain, g/day) of formula-fed and/or breastfed infants in high dose group versus placebo group from enrolment to 8 weeks of intervention

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.

Detailed Description

This is a randomized, placebo-controlled, double-blind study of healthy term infants, consisting of three randomized arms: placebo control group, high dose experimental group, and low dose experimental group. The study population, approximately 228, are infants 14 - 21 days of age who are formula-fed and/or breastfed who is aligned with the intended target population for a probiotic supplement. Placebo and probiotic supplements will be mixed with formula or breastmilk and fed orally using a feeding cup or syringe. All enrolled infants will participate in the trial for approximately 8 weeks.

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.
228

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

  • Philippines
      • Muntinlupa, Philippines, 1781
        • Asian Foundation for Tropical Medicine, Inc.

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

2 weeks to 3 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the study.
  2. Infants whose parent(s)/LAR have reached the legal age of majority in the countries where the study is conducted.
  3. Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
  4. Infants whose parent(s)/LAR can be contacted directly by telephone throughout the study.
  5. Infants whose parent(s)/LAR have access to a working freezer.

  6. Infants must meet all the following inclusion criteria to be eligible for enrolment into the study:

    1. Healthy term (37-42 weeks of gestation) infant at birth.
    2. At enrolment visit, post-natal age 14-21 days (date of birth = day 0)
    3. Birth weight ≥ 2500g and ≤ 4500g.
    4. Breastfed and/or formula-fed infants (including exclusively and mixed fed breast- and formula-fed infants) whose parent(s)/LAR intent not to change the feeding regimen until the study end at 8 weeks of intervention.
    5. Formula-fed infants and their parent(s)/LAR must have independently elected, before enrolment not to breastfeed and their infant must tolerate a standard cow's milk infant formula not containing any probiotics at time of enrolment.

Exclusion Criteria:

  1. Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol.
  2. Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrollment.

  3. Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:

    1. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
    2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
    3. History of admission to the Neonatal Intensive Care Unit (NICU), except for admission for jaundice phototherapy.
    4. Other severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the study.
  4. Infants who are presently receiving or have received prior to enrollment probiotic supplements or any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion.
  5. Currently participating or having participated in another clinical trial since birth.

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: Double

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.
Experimental: Experimental Group 1
High dose probiotic supplement and maltodextrin as the excipient
Other: High dose probiotic supplement
One probiotic stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.
Experimental: Experimental Group 2
Low dose probiotic supplement and maltodextrin as the excipient
Other: Low dose probiotic supplement
One probiotic stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.
Placebo Comparator: Control Group
Placebo supplement containing only maltodextrin but having the same appearance as the probiotic supplements
Other: Placebo
One placebo stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.

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
Safety of high dose probiotic supplement (weight gain)
Time Frame: Day 56
Compare the growth (weight gain, g/day) of formula-fed and/or breastfed infants in EG 1 vs. CG from enrolment to 8 weeks of intervention
Day 56

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
Efficacy of two different doses of probiotic supplement
Time Frame: Day 0, Day 25-27, Day 53-55
Bifidobacteria abundance measured in the fecal sample collected at home after 8 weeks of intervention (V3) analyzed by next generation sequencing (NGS) technology.
Day 0, Day 25-27, Day 53-55

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Additional growth parameters: weight
Time Frame: Day 0, Day 28, Day 56
Weight in grams and corresponding weight-for-age Z-score according WHO growth standards
Day 0, Day 28, Day 56
Additional growth parameters: length
Time Frame: Day 0, Day 28, Day 56
Length in centimeters and corresponding length-for-age Z-score according WHO growth standards
Day 0, Day 28, Day 56
Additional growth parameters: head circumference
Time Frame: Day 0, Day 28, Day 56
Head circumference in centimeters and corresponding head circumference-for-age Z-score according WHO growth standards
Day 0, Day 28, Day 56
Additional growth parameters: body mass index
Time Frame: Day 0, Day 28, Day 56
BMI and corresponding BMI-for-age Z-score according WHO growth standards
Day 0, Day 28, Day 56
Fecal microbiome composition
Time Frame: Day 0, Day 28, Day 56
Overall fecal microbiota composition, diversity, and microbiota community types will be assessed using NGS technology (including relative abundance of beneficial bifidobacteria bacteria species and pathogenic bacteria species) and
Day 0, Day 28, Day 56
Bifidobacteria colonization
Time Frame: Day 0, Day 28, Day 56
Bifidobacteria colonization using a newly developed rapid diagnostic kit
Day 0, Day 28, Day 56
Fecal microbiome: Continuation of bifidobacteria colonization
Time Frame: Day 84
Continuation of bifidobacteria colonization 4 weeks after intervention stop using NGS technology and DNAFoil® technology
Day 84
Fecal metabolic profile: Fecal pH
Time Frame: Day 0, Day 28, Day 56
Fecal pH
Day 0, Day 28, Day 56
Fecal metabolic profile: Fecal organic acids
Time Frame: Day 0, Day 28, Day 56
Fecal organic acids (such as, but not restricted to lactate, propionate, butyrate, acetate, valerate, and total fecal organic acids)
Day 0, Day 28, Day 56
Fecal metabolic profile: gut microbiota-derived metabolites
Time Frame: Day 0, Day 28, Day 56
Concentration of gut microbiota-derived metabolites using mass spectrometry and/or nuclear magnetic resonance
Day 0, Day 28, Day 56
Biological response of selected fecal metabolites
Time Frame: Day 0, Day 28, Day 56
Biological response using cultured cell lines or combinations of cell lines (Cell-based functional assays)
Day 0, Day 28, Day 56
Fecal markers of immune health and gut barrier
Time Frame: Day 0, Day 28, Day 56
Total secretory IgA, calprotectin, and α-1-antitrypsin assessed by ELISA and Fecal cytokine levels (such as, but not restricted to: IL-1ra, IL-1α, IL-1β, IL-6, IFN- γ, and TNF-α) will be measured by multiplex assays
Day 0, Day 28, Day 56
GI tolerance
Time Frame: Day 0, Day 28, Day 56
Infant Gastrointestinal Symptom Questionnaire (IGSQ-13) Index Score for overall GI tolerance calculated from the IGSQ-13
Day 0, Day 28, Day 56
GI-related behaviors: Stool frequency
Time Frame: Day 0, Day 25-27, Day 53-55
GI endpoints will be recorded via the 1-day and 3-day GI Symptom and Behavior Diary
Day 0, Day 25-27, Day 53-55
GI-related behaviors: Stool consistency
Time Frame: Day 0, Day 25-27, Day 53-55
Stool consistency using a validated 5-point scale in the 1-day and 3-day GI Symptom and Behavior Diary
Day 0, Day 25-27, Day 53-55
GI-related behaviors: Incidence of spitting-up
Time Frame: Day 0, Day 25-27, Day 53-55
Incidence of spitting-up using a Likert scale via the 1-day and 3-day GI Symptom and Behavior Diary
Day 0, Day 25-27, Day 53-55
GI-related behaviors: Incidence of flatulance
Time Frame: Day 0, Day 25-27, Day 53-55
Flatulence of spitting-up using a Likert scale via the 1-day and 3-day GI Symptom and Behavior Diary
Day 0, Day 25-27, Day 53-55
GI-related behaviors: Crying time
Time Frame: Day 0, Day 25-27, Day 53-55
Crying time (hours/min) via the 1-day and 3-day GI Symptom and Behavior Diary
Day 0, Day 25-27, Day 53-55
GI-related behaviors: Sleep time
Time Frame: Day 0, Day 25-27, Day 53-55
Sleep time (hours/min) using a Likert scale via the 1-day and 3-day GI Symptom and Behavior Diary
Day 0, Day 25-27, Day 53-55

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.
Société des Produits Nestlé (SPN)

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 (Actual)

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.
February 26, 2021

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.
August 23, 2021

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.
October 12, 2021

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).
November 12, 2020

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.
February 18, 2021

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.
February 23, 2021

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.
March 24, 2023

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.
March 22, 2023

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.
March 1, 2023

More Information

Terms related to this study

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.
  • 20.11.INF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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