Human Milk Oligosaccharides (HMOs) Post-market Study on Infants (NEHMO)

NCT05150288 | Completed DMC

• 1 other identifier: 1806INF- DACH
• Study Type: interventional
• Target: 106
• Locations: 3 countries
• Sites: 17

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 monitor the safety \& tolerance of HMOs-supplemented formulas in larger and diverse infant populations; to assess the performance of HMOs-supplemented formulas in mixed-fed infants, a population that was not studied in previous RCTs but likely represents a relatively common feeding regimen. Finally, 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 and compare with breastfed infants data.

Conditions

Growth; Tolerance; Adverse Event; Disorder of Intestine; Formula Satisfaction

Keywords

Growth; Tolerance; Adverse Event; Gastrointestinal tolerance; Infant formula; Human milk oligosaccharides; 2'-fucosyllactose; Lacto-N-neotetraose; Real-world

Outcome Measures

Primary Outcomes (6)

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

  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) head-circumference-for-age z-scores

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

  8 weeks (study end)

• World Health Organization (WHO) based body-mass-index (BMI)-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 (study midpoint)

• 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

  8 weeks (study end)

Secondary Outcomes (6)

• Formula acceptability

  4 weeks (study midpoint), 8 weeks (study end)

• Standard adverse events (AEs) reporting for safety assessment

  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 intervention

• Weight

  8 weeks (study end)

• Length

  8 weeks (study end)

• Head circumference

  8 weeks (study end)

Study Arms (3)

Formula-fed infants

EXPERIMENTAL

Infants fed exclusively with experimental formula

Other: HMO-supplemented infant formula

Mixed-fed infants

EXPERIMENTAL

Infants receiving breastmilk and experimental formula

Other: HMO-supplemented infant formula

Breast-fed infants

NO INTERVENTION

Reference group of exclusively breastfed

Interventions

HMO-supplemented infant formula OTHER

Starter Infant Formula supplemented with 1.5g/L of Human Milk Oligosaccharides

Formula-fed infants; Mixed-fed infants

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) have 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

You may not qualify if:

• Any known intolerance/allergy to cow's milk (formula-fed group only)
• systemic disorders (cardiac, respiratory, endocrinological, hematologic, gastointestinal, or other)
• conditions requireing infant feedings other than those specified in the protocol
• Infants must have been exclusively consuming breast milk since birth, and their parent(s) must have made the decision to continue exclusively breastfeeding until at least 4 month of age

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Waldkrankenhaus Protestant Hospital, Spandau: collaborator
• Kinderarztpraxis Köllges, Mossakowski und Meyer-Krott, Mönchengladbach: collaborator
• Gemeinschaftspraxis Kinder- und Jugendpraxis Dr. Stepan Dreher und Tina Hübler, Geldern: collaborator
• Kinder- und Jugendarzt Dr. Umpfenbach und Dr. Lorenz, Viersen: collaborator
• Kinder- und Jugendärztliche Gemeinschaftspraxis Bedikian & Bouikidis, Oberhausen: collaborator
• Kinderarztpraxis Dr. Zakarian, Düsseldorf: collaborator
• Facharztpraxis für Kinder- und Jugendmedizin Dr. Aulinger, Burglengenfeld: collaborator
• Zentrum für Kinder- und Jugendgesundheit Regensburg: collaborator
• Kinder- und Jugendarztpraxis Schwabach: collaborator
• Praxis Dr. Klee, Bürstadt: collaborator
• Facharzt für Säuglings-, Kinder- und Jugendmedizin, Bremen: collaborator
• Praxis Al-Radhi, Ehingen: collaborator
• Kinder und Jugendarztpraxis Dr. Maier, Leinfelden-Echterdingen: collaborator
• Kinder- und Jugendarztpraxis Dr. Kröckel, Dr. Ciesla, Berlin: collaborator
• Facharzt für Kinder- und Jugendheilkunde Dr. Faustmann, Oberwart: collaborator
• Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland: collaborator
• Global Medical Affairs, Société des Produits Nestlé S.A., Vevey, Switzerland: collaborator

Study Sites (17)

Facharzt für Kinder- und Jugendheilkunde

Oberwart, 7400, Austria

Location

Kinder- und Jugensarztpraxis

Berlin, 12689, Germany

Location

Evangelisches Waldkrankenhaus Spandau

Berlin-Spandau, 13589, Germany

Location

Facharzt für Säuglings-, Kinder- und Jugendmedizin

Bremen, 28211, Germany

Location

Facharztpraxis für Kinder- und Jugendmedizin

Burglengenfeld, 93133, Germany

Location

Praxis Dr. Klee

Bürstadt, 68642, Germany

Location

Kinderarztpraxis

Düsseldorf, 40223, Germany

Location

Praxis Al-Radhi

Ehingen, 89584, Germany

Location

Gemeinschaftspraxis Kinder- und Jugendarztpraxis

Guelders, 47608, Germany

Location

Kinder und Jugendarztpraxis

Leinfelden-Echterdingen, 70771, Germany

Location

Kinderarztpraxis Köllges

Mönchengladbach, 41236, Germany

Location

Kinder- und Jugendärztliche Gemeinschaftspraxis

Oberhausen, 46145, Germany

Location

Zentrum für Kinder- und Jugendgesundheit

Regensburg, 93049, Germany

Location

Kinder- und Jugendarztpraxis

Schwabach, 91126, Germany

Location

Kinder- und Jugendarzt

Viersen, 41751, Germany

Location

Nestlé Research, Société des Produits Nestlé S.A.

Lausanne, 1000, Switzerland

Location

Global Medical Affairs, Société des Produits Nestlé

Vevey, 1800, Switzerland

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 BACKGROUND

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 9, 2021
• Study Start: July 8, 2019
• Primary Completion: July 24, 2020
• Study Completion: July 24, 2020
• Last Updated: December 9, 2021

Record last verified: 2021-11

Locations

AU (1); DE (14); CH (2)