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Completed

NCT Number: NCT03710551

Happy Smooth Study

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.

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Key information

Conditions

Infant Term Birth

Age range

21 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asian Hospital and Medical Center

City of Muntinlupa, 1781, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental Infant Formula

Other

Standard bovine milk-based infant formula with a new fat blend plus L. reuteri, fed ad libitum

Standard Infant Formula

Other

Standard bovine milk-based infant formula, fed ad libitum

Primary outcomes

  1. Stool Consistency Score

    Time frame: Study Day 57, corresponding to infant age of 78-85 days

    3-day Gastrointestinal (GI) Symptom and Behavior Diary, a parent-reported symptom diary to record stool consistency and stool frequency over the 3 consecutive days.

    A validated 5-point pictorial representation of the consistency of the stool for infants ≤1 year (1=watery, 2=runny, 3=mushy soft, 4=formed, 5=hard) will be provided in the stool diary for parent(s)/LAR to visually assess the infants' stools.

    Stool consistency will be compared between formula groups The baseline stool consistency value will also be included in the model as a covariate.

    the percentage of stools in each category (watery, runny, mushy soft, formed, or hard) will be calculated by visit for each infant and then will be summarized using the appropriate descriptive statistics. Figures composed of a series of histograms will be produced for each 3-day stool diary period.

Secondary outcomes

  1. GI Tolerance

    Time frame: which corresponds to infant age of 21-28, 43-50, and 78-85 days.

    Infant Gastrointestinal Symptom Questionnaire (IGSQ)

    Overall GI symptom burden will be measured with the IGSQ-13 questionnaire. The IGSQ-13 is an interviewer-administered questionnaire which measures how well the infant tolerates his/her feedings from the parent's/caregiver's perspective. The questionnaire is composed of 13 questions, categorized into 5 symptom domains of stooling, vomiting/spitting-up, crying, fuzziness, and flatulence and summed to calculate an index score.

  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)

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 18, 2018
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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