Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Happy Smooth Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03710551
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
The purpose of this study is to evaluate the stool composition and GI tolerance of an experimental formula with a new fat blend plus L. reuteri vs control formula.

Condition or disease Intervention/treatment Phase
Infant Term Birth Other: Experimental Infant Formula Other: Standard Infant Formula Not Applicable

Detailed Description:
Double-blind, randomized, controlled clinical trial. The purpose of this study is to evaluate the stool composition and GI tolerance of 140 healthy, term infants fed with an infant formula with a new fat blend plus L. reuteri vs a standard infant formula. All enrolled infants will participate in the trial for approximately 71 days.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Stool Composition and GI Tolerance in Infants Fed a Term Infant Formula With a New Fat Blend Plus L.Reuteri: a Randomized Controlled Trial
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Infant Formula
Experimental Infant Formula with a new fat blend plus L. reuteri
Other: Experimental Infant Formula
Standard bovine milk-based infant formula with a new fat blend plus L. reuteri, fed ad libitum

Active Comparator: Standard Infant Formula
Standard bovine milk-based infant formula.
Other: Standard Infant Formula
Standard bovine milk-based infant formula, fed ad libitum




Primary Outcome Measures :
  1. Stool Consistency Score [ Time Frame: Study Day 57, corresponding to infant age of 78-85 days ]
    published, validated 5-point stool scale


Secondary Outcome Measures :
  1. GI Tolerance [ Time Frame: which corresponds to infant age of 21-28, 43-50, and 78-85 days. ]
    As measured by IGSQ index score at Study Day 1, 22, and 57.

  2. Changes in Weight from baseline to 57 days [ Time Frame: Study Day 57, corresponding to infant age of 78-85 days ]
    weight (kg)

  3. Changes in Length from baseline to 57 days [ Time Frame: Study Day 57, corresponding to infant age of 78-85 days ]
    length (cm)

  4. Changes in Head Circumference from baseline to 57 days [ Time Frame: Study Day 57, corresponding to infant age of 78-85 days ]
    head circumference (cm)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written Informed Consent
  • Infants whose parents/LAR have reached the legal age of majority in the Philippines
  • Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol
  • Infants whose parent(s)/LAR are able to be contacted directly by telephone throughout the study
  • Healthy term, singleton infant at birth
  • Between 21 to 28 days post-natal age at enrollment visit
  • Weight-for-age ≥ 5th and ≤ 95th percentile according to World Health Organization growth tables/charts
  • Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment

Exclusion Criteria:

  • Infants with conditions requiring infant feedings other than those specified in the protocol
  • Infants receiving complementary foods or liquids
  • 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
  • Infants who are presently receiving or have received medications that could interfere with the interpretation of the study results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710551


Contacts
Layout table for location contacts
Contact: Elvira M Estorninos 632 771 9233 elvie_323@yahoo.com

Locations
Layout table for location information
Philippines
Asian Hospital and Medical Center Recruiting
Muntinlupa, Philippines, 1781
Contact: Sylvia C Estrada, MD    +63 2 771 90 00 ext 8417    irb@asianhospital.com   
Contact: Jomer Caballero, BS    +63 2 771 90 00 ext 8417    irb@asianhospital.com   
Principal Investigator: Elvira M Estorninos, MD         
Sponsors and Collaborators
Nestlé
Investigators
Layout table for investigator information
Principal Investigator: Elvira M Estorninos University of Alberta

Layout table for additonal information
Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03710551     History of Changes
Other Study ID Numbers: 16.28.INF
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No