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

NCT07302477 | Completed DMC

• 1 other identifier: 18.06.INF-Pakistan-TmpDel
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Growth; Tolerance; Adverse Event

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Formula acceptability

  4 Weeks (study midpoint) and 8 weeks (study end point)

• Standard adverse events (AEs) reporting for safety assessment

  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

Study Arms (1)

Infants Fed Infant Formula

EXPERIMENTAL

Infant either Fed Exclusive Infant Formula or on Mixed feeding.

Other: HMO Supplemented Infant Formula

Interventions

HMO Supplemented Infant Formula OTHER

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.

Infants Fed Infant Formula

Eligibility Criteria

• Age: 7 Days - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Parent(s) Are willing and able to fulfill the requirements of the study protocol
• Healthy full term (37-42 weeks gestation) infant
• Be between post-natal age (Date of Birth = Day 0) 7 days to 2 months
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (4)

Quaid E Azam Medical College

Chak Four Hundred Fifty-four, Pakistan

Location

Liaqat National Hospital

Karachi, Pakistan

Location

Fatima Memorial Hospital

Lahore, Pakistan

Location

Khawaja Muhammad Safdar Medical College

Sialkot, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 30906817 RESULT

Related Links

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

Study Officials

• Huma Fahim

  Nestle

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: July 29, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (4)