Happy Smooth Study

Infant Term Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03710551
• Other study ID #: 16.28.INF
• Status: Completed
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: July 21, 2019

Study information

• Verified date: February 2021
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 21, 2019
• Est. primary completion date: June 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant Term Birth

Intervention

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

Locations

Country	Name	City	State
Philippines	Asian Hospital and Medical Center	Muntinlupa

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool Consistency Score	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.	Study Day 57, corresponding to infant age of 78-85 days
Secondary	GI Tolerance	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.	which corresponds to infant age of 21-28, 43-50, and 78-85 days.
Secondary	Changes in Weight from baseline to 57 days	weight (kg)	Study Day 57, corresponding to infant age of 78-85 days
Secondary	Changes in Length from baseline to 57 days	length (cm)	Study Day 57, corresponding to infant age of 78-85 days
Secondary	Changes in Head Circumference from baseline to 57 days	head circumference (cm)	Study Day 57, corresponding to infant age of 78-85 days