---
title: Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs
nct_id: NCT03513744
overall_status: COMPLETED
phase: NA
sponsor: Jennewein Biotechnologie GmbH
study_type: INTERVENTIONAL
primary_condition: Infant Nutrition
countries: Germany, Italy, Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03513744.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03513744"
ct_last_update_post_date: 2023-10-16
last_seen_at: "2026-05-12T07:22:34.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs

**Official Title:** Evaluation of Nutritional Suitability and Tolerability of a Human Milk Oligosaccharide (HMO) Mix in Infant Formula for Term Infants

**NCT ID:** [NCT03513744](https://clinicaltrials.gov/study/NCT03513744)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 340
- **Lead Sponsor:** Jennewein Biotechnologie GmbH
- **Collaborators:** Analyze & Realize
- **Conditions:** Infant Nutrition
- **Start Date:** 2018-11-19
- **Completion Date:** 2021-04-05
- **CT.gov Last Update:** 2023-10-16

## Brief Summary

The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.

## Detailed Description

The main goal of the study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth of term infants (evaluated per weight gain, body length and head circumference), in comparison with infant formula without human milk oligosaccharides, when the formula is fed exclusivly in the first four month of life. Additionally, a comparison of the two formula fed groups against a reference group with breastfed infants as well as the WHO growth standard reference tables will be performed. An assessment of safety and tolerability will be performed as well.

As a secondary out come of the study, we will examine the effect of the formula on the infant microbiome, as well as the HMO status of the mother's milk towards the microbial composition of the infant microbiome.

## Eligibility

- **Minimum age:** 1 Day
- **Maximum age:** 13 Days
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Singleton birth
* Full-term infant (37 - 42 weeks of gestational age)
* APGAR score of 9 or 10
* Birth weight 2500 - 4500 g

Exclusion Criteria:

* clinically significant condition/ disorder
* Adverse maternal of fetal medical history that may influence growth/development of the subject or tolerance of the infant formula
* readmission to hospital (except for hyperbilirubinemia)
* allergy to cow's milk
* participation in another study
```

## Arms

- **infant formula containing five HMOs** (EXPERIMENTAL)
- **infant formula** (NO_INTERVENTION)
- **breast milk group** (NO_INTERVENTION)

## Interventions

- **human milk oligosaccharides** (DIETARY_SUPPLEMENT) — mixture of five different human milk oligosaccharides

## Primary Outcomes

- **assessment of body weight (in grams) of term infants** _(time frame: 4 month)_ — growth, assessed by body weight gain, of term infants from enrollment to 4 month of life

## Secondary Outcomes

- **assessment of body length (in centimeter) of term infants** _(time frame: 4 month)_
- **assessment of head circumference (in centimeter) of term infants** _(time frame: 4 month)_

## Locations (9)

- Facharzt für Kinder und Jugendmedizin, Mannheim, Germany
- Klinikum Südstadt Rostock, Rostock, Germany
- ASST Spedali Civili di Brescia - Presidio Ospedale dei Bambini, Brescia, Italy
- Ospedale San Raffaele, Milan, Italy
- Hospital HM Puerta del Sur, Madrid, Spain
- Hospital HM Monteprincipe, Madrid, Spain
- Hospital HM Nuevo Belen, Madrid, Spain
- Hospital Universitario Sant Joan de Reus, Reus, Spain
- Hospital Joan XXII of Tarragona, Tarragona, Spain

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.facharzt für kinder und jugendmedizin|mannheim||germany` — added _(2026-05-12)_
- `locations.klinikum südstadt rostock|rostock||germany` — added _(2026-05-12)_
- `locations.asst spedali civili di brescia - presidio ospedale dei bambini|brescia||italy` — added _(2026-05-12)_
- `locations.ospedale san raffaele|milan||italy` — added _(2026-05-12)_
- `locations.hospital hm puerta del sur|madrid||spain` — added _(2026-05-12)_
- `locations.hospital hm monteprincipe|madrid||spain` — added _(2026-05-12)_
- `locations.hospital hm nuevo belen|madrid||spain` — added _(2026-05-12)_
- `locations.hospital universitario sant joan de reus|reus||spain` — added _(2026-05-12)_
- `locations.hospital joan xxii of tarragona|tarragona||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03513744.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03513744*  
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