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GrowthNCT07302477

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

A study testing HMO Supplemented Infant Formula in people with Growth and Tolerance, run by Société des Produits Nestlé (SPN) at 4 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 7 days to 2 monthsHealthy volunteers can take part
Conditions the study is for
Growth, Tolerance, Adverse Event
What is being tested?
HMO Supplemented Infant Formula
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
4 sitesPakistan
Study dates
29 Jul 2021to 15 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 days to 2 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Pakistan4 sites

  • Quaid E Azam Medical College

    Chak Eighty-seven -Twelve Left

  • Liaqat National Hospital

    Karachi

  • Fatima Memorial Hospital

    Lahore

  • Khawaja Muhammad Safdar Medical College

    Sialkot

Other trials in Pakistan

About this study

Official title: 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.

Read the 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

Being tested
HMO Supplemented Infant Formula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HMO Supplemented Infant FormulaOther

    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.

Study groups in NCT07302477
Study groupRoleWhat they receive
Infants Fed Infant FormulaExperimentalInfant either Fed Exclusive Infant Formula or on Mixed feeding.
Receives: Other: HMO Supplemented Infant Formula

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 8 Weeks (Study End)

  2. World Health Organization (WHO) based length-for-age z-scores

    Length-for-age z-scores using WHO growth standards

    Measured: 8 Weeks (Study End)

  3. World Health Organization (WHO) based weight-for-age z-scores

    Weight-for-length z-scores using WHO growth standards

    Measured: 8 Weeks (Study End)

  4. World Health Organization (WHO) based weight-for-age z-scores

    head-circumference-for-age z-scores using WHO growth standards

    Measured: 8 Weeks (Study End)

  5. 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

    Measured: 8 Weeks (Study End)

  6. 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.

    Measured: 4 Weeks (Midpoint) and 8 Weeks (Study End Point)

Secondary outcomes (2)

  1. Formula acceptability

    Study Formula Satisfaction Questionnaire

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

  2. 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2025
  2. Study start29 Jul 2021
  3. Primary completion15 Dec 2022
  4. Study completion15 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07302477
Sponsor's protocol ID
18.06.INF-Pakistan-TmpDel
Status last verified
Dec 2025
First submitted
11 Dec 2025
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 30906817

Questions about this trial

What is this clinical trial studying?

A study testing HMO Supplemented Infant Formula in people with Growth and Tolerance, run by Société des Produits Nestlé (SPN) at 4 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)] (time frame: 8 Weeks (Study End)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07302477, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.

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