Human Milk Oligosaccharides (HMOs) - Post Marketing Study on Infants (NeHMO)

Growth and Feeding Tolerance of Infants Consuming a Formula Supplemented With Human Milk Oligosaccharides (HMOs): An Uncontrolled, Open-label, Prospective Study

Human milk oligosaccharides (HMOs) represent the third largest solid component of breast milk. Technology advancements made it possible to supplement infant formulas with HMOs (2'FL, LNnT). Two published RCTs have demonstrated that infant formulas supplemented with 2'FL or 2'FL+LNnT are safe, well-tolerated, support normal grow, and may support healthy GI function and confer immune benefits. The performance of HMOs-supplemented formulas assessed in a real-world setting is complementary to previously conducted RCTs conducted in highly controlled clinical settings. Main objectives will be to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs in a real-world setting. In addition to it considering the potential health/immune benefits of HMOs, it is also important explore the incidences of illnesses (i.e., respiratory illnesses, GI illnesses, and fever) associated with consuming HMOs-supplemented formulas.

Study Overview

• Status: Completed
• Conditions: Growth; Tolerance; Adverse Event
• Intervention / Treatment: Other: HMO Supplemented Infant Formula

Detailed Description

Objectives:

The main objective of this study is to document the growth and feeding tolerance of healthy term infants consuming an infant formula supplemented with HMOs for 8 weeks (56 days), in a real-world setting.

Main endpoints:

1. Growth documented via monitoring the anthropometric parameters including weight, length, head circumference, BMI and their corresponding z-scores (i.e., z-scores for weight-for-age, length-for-age, weight-for-length, head circumference-for-age, and BMI-for-age) calculated using the 2006 WHO Growth Standards
2. Feeding tolerance assessed via monitoring parent-reported overall GI symptom burden measured by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score (13-item summary score)

Additional objectives:

To describe the following outcomes in infants fed an infant formula supplemented with HMOs:

1. Formula acceptability
2. Despite there are no expected safety concerns, standard Adverse Events (AEs) monitoring will be implemented during the study

Additional endpoints:

1. Formula acceptability assessed by the Study Formula Satisfaction Questionnaire

2. Reported AEs and Serious Adverse Events (SAEs) including type, incidence, severity, seriousness and relation to study formula consumption as well as concomitant medications and non-pharmacological treatments.

   • Select morbidities of interest (i.e., respiratory illnesses, GI illnesses, and fever) will be collected as part of AE reporting and specific corresponding AE guidance forms will be used to standardize reporting of such AEs

Trial design:

Uncontrolled, single arm, open-label, prospective study in infants (enrolled at postnatal age 7 days to 2 months) fed the study formula for 8 weeks (56 days)

Trial population:

Healthy, male and female, term infants, 7 days postnatal age to 2 months of age at the enrollment

Treatment duration:

Total study participation/intervention up to approximately 8 weeks

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Chak Eighty-seven -Twelve Left, Pakistan
    • Quaid E Azam Medical College
  • Karachi, Pakistan
    • Liaqat National Hospital
  • Lahore, Pakistan
    • Fatima Memorial Hospital
  • Sialkot, Pakistan
    • Khawaja Muhammad Safdar Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Evidence of personally signed and dated informed consent document indicating that the infant's parent(s) has been informed of all pertinent aspects of the study
2. Parent(s) Are willing and able to fulfill the requirements of the study protocol
3. Healthy full term (37-42 weeks gestation) infant
4. Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
5. Parent(s) must have independently elected, before enrollment, to formula feed. IF or mixed feeding. Prior to enrollment parents were counselled about the superiority and advantages of exclusive breastfeeding.

Exclusion Criteria:

1. Had any known case of intolerance/allergy to cow's milk (for formula-fed group only)
2. Had conditions requiring infant feedings other than those specified in the protocol
3. Evidence of significant cardiac, respiratory, endocrinologist, hematologic, gastrointestinal, or other systemic diseases/disorders
4. Parent(s) refusal to participate in the study
5. Infant had consumed any other infant formula in 3 days prior to study start

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Infants Fed Infant Formula; Infant either Fed Exclusive Infant Formula or on Mixed feeding.	Other: HMO Supplemented Infant Formula; Starter Infant formula supplemented with 0.18 g /100g powder of 2'FL HMOs,1.2 g protein/100 ml (70% whey) and. B. Lactis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization (WHO) based weight-for-age z-scores Weight-for-age z-scores using WHO growth standards [Time Frame: 8 weeks (study end)]	Weight-for-age z-scores using WHO growth standards	8 Weeks (Study End)
World Health Organization (WHO) based length-for-age z-scores	Length-for-age z-scores using WHO growth standards	8 Weeks (Study End)
World Health Organization (WHO) based weight-for-age z-scores	Weight-for-length z-scores using WHO growth standards	8 Weeks (Study End)
World Health Organization (WHO) based weight-for-age z-scores	head-circumference-for-age z-scores using WHO growth standards	8 Weeks (Study End)
World Health Organization (WHO) based weight-for-age z-scores	Weight and height will be combined to calculate BMI in kg/m^2, then BMI-for-age z-scores will be derived using WHO growth standards	8 Weeks (Study End)
Feeding Tolerance	The Infant Gastrointestinal Symptom Questionnaire (IGSQ) index score will be used to assess GI distress. This is a validated 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress. A composite IGSQ score is derived from summing the individual scores with a possible range of 13 to 65 where higher values indicate greater GI distress and values ≤23 indicate no digestive distress.	4 Weeks (Midpoint) and 8 Weeks (Study End Point)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Formula acceptability	Study Formula Satisfaction Questionnaire	4 Weeks (study midpoint) and 8 weeks (study end point)
Standard adverse events (AEs) reporting for safety assessment	Reported adverse events (AEs) and Serious Adverse Events (SAEs) include type, incidence, severity, seriousness and relation to feeding	Time Frame: From the time the informed consent form has been signed at enrollment infant age less than 7 days to 2 months through the 8 weeks of interventio

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Investigators: Study Director: Huma Fahim, Nestle

Publications and helpful links

General Publications

• Storm HM, Shepard J, Czerkies LM, Kineman B, Cohen SS, Reichert H, Carvalho R. 2'-Fucosyllactose Is Well Tolerated in a 100% Whey, Partially Hydrolyzed Infant Formula With Bifidobacterium lactis: A Randomized Controlled Trial. Glob Pediatr Health. 2019 Mar 15;6:2333794X19833995. doi: 10.1177/2333794X19833995. eCollection 2019.

Helpful Links

• 2'-Fucosyllactose Is Well Tolerated in a 100% Whey, Partially Hydrolyzed Infant Formula With Bifidobacterium lactis: A Randomized Controlled Trial

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 18.06.INF-Pakistan-TmpDel

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No