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

NCT04055363 | Completed DMC

• 1 other identifier: 1806INF - Spain
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 6

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; Disorder Lung

Keywords

Growth; Tolerance; Adverse Event; Gastrointestinal disorder; Respiratory infection; Gastrointestinal infection

Outcome Measures

Primary Outcomes (7)

• 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) weight-for-length z-scores

  Weight-for-length 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:

• 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
• 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
• Puerta de Hierro University Hospital: collaborator
• University of Navarrra Hospital (Clinica Universitaria): collaborator
• Grupo Pulso: collaborator
• Casa de la Salud Hospital: collaborator
• Vitha Santa Catalina Hospital: collaborator
• Quirón-Dexeus Universitary Hospital: collaborator
• Hospital Ruber Internacional: collaborator
• Grupo Hispalense de Pediatría Hospital: collaborator
• MH Belén Maternal Hospital: collaborator

Study Sites (6)

Vitha Santa Catalina Hospital

Las Palmas de Gran Canaria, Canary Islands, 35005, Spain

Location

Hospital Maternal MH Belén

A Coruña, Galicia, 15011, Spain

Location

Universitary Hospital Quirón-Dexeus

Barcelona, 08028, Spain

Location

Ruber Internacional Clinic

Madrid, 28034, Spain

Location

Hispalense Group

Seville, Spain

Location

Casa de la Salud, Hospital

Valencia, 46021, Spain

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; Lung Diseases; Gastrointestinal Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Digestive System Diseases; Respiratory Tract Diseases; Infections

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: July 11, 2019
• First Posted: August 13, 2019
• Study Start: October 1, 2018
• Primary Completion: November 30, 2018
• Study Completion: December 31, 2018
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

ES (6)