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Completed

NCT Number: NCT04441359

Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula

The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes.

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Key information

Conditions

Infection Communicable Diseases Disease Attributes Healthy Infections Microbial Colonization Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 day–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ZNA Koningin Paola Kinderziekenhuis, Antwerp, Belgium

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About this study

The study primarily aimed to evaluate the effects of long-term supplementation of an infant formula with a mixture of short and long chain inulin-type oligosaccharides on immunological-health related outcomes, as well as on gastrointestinal function and well-being in infants during the first year of life. Effects on infant growth, tolerance and on the composition of fecal microbiota were further objectives of this study. The study was conducted as a multicenter, randomised, double-blind, placebo-controlled study in healthy term infants. The two groups of the study are product group (standard infant formula supplemented with inulin-type fructans) and control group (non-supplemented standard infant formula).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy babies born between 37 - 42 weeks of gestation and with weight appropriate for gestational age (between percentiles 3 and 97)
  • Healthy babies aged between 0 - 4 months of age
  • Babies exclusively fed with an infant formula on enrolment into the study

Exclusion criteria

  • The presence of an infection at the moment of the recruitment or 1 week before recruitment
  • The presence of important pathologies (intestinal, cardiopathy, mental retardation, etc.)
  • Any other diseases related to the immune system (primary immunodeficiency)
  • Parents not able to comply with the study follow up (according to physician criteria)

Treatment and study plan

Supplemented formula

Other

standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans

Standard formula

Other

standard infant formula not supplemented with prebiotic inulin-type fructans

Primary outcomes

  1. Incidence of infections during first year of life

    Time frame: until infant reaches age of 1 year

    measured through presence of fever, and number and duration of infectious episodes

Secondary outcomes

  1. Stool frequency

    Time frame: until infant reaches age of 1 year

    Number of depositions per day assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)

  2. Stool consistency

    Time frame: until infant reaches age of 1 year

    Assessed via 1-3 scale with pictograms (1=hard, 2=soft/formed, 3=liquid/semi-liquid), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)

  3. Digestive tolerance

    Time frame: until infant reaches age of 1 year

    Number of vomiting and regurgitation episodes per day and presence of excessive flatulence and infantile colic, assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)

  4. Growth

    Time frame: until infant reaches age of 1 year

    Calculation of z-scores of weight-for-age and length-for-age according to the World Health Organisation (WHO) standards using WHO software (WHO Antro software).

  5. Body weight

    Time frame: until infant reaches age of 1 year

    Assessment of weight (kg) of the nude infant via calibrated electronic scales at all study visits.

  6. Body height

    Time frame: until infant reaches age of 1 year

    Assessment of height (cm) in supine position by using a standard measuring board at all study visits.

  7. Head circumference

    Time frame: until infant reaches age of 1 year

    Assessment of head circumference (cm) using a non-extendable insertion tape at all study visits.

  8. Sleeping habits

    Time frame: until infant reaches age of 1 year

    Assessment of total hours slept and total hours of nocturnal sleeping per day (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period).

  9. Crying episodes

    Time frame: until infant reaches age of 1 year

    Assessment of crying episodes (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period).

  10. Effect on fecal microbiota composition

    Time frame: until infant reaches age of 1 year

    Quantification of dominant bacterial groups

  11. Effect on development of allergy

    Time frame: until infant reaches age of 1 year

    Presence of clinical symptoms compatible with food allergies, atopic dermatitis, exanthema

  12. Effect on immunology markers in feces

    Time frame: until infant reaches age of 1 year

    secretory immunoglobulin A, calprotectin level

Sponsors and collaborators

Lead sponsor

Beneo-Institute

Industry

Collaborators

  • European Union
  • Laboratorios Ordesa

Registry information

Official study title

Effects of the Supplementation With Oligosaccharides on the Prevention of Infections in Infants

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 22, 2020
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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