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Completed

NCT Number: NCT01956682

Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying

The primary objective of this trial is to show that an hypoallergenic infant starter formula containing starch and the probiotic L. reuteri decreases the severity of regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have taken it for 4 weeks, in comparison with a standard infant starter formula.

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Key information

Conditions

Regurgitation, Gastric Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Laryngeal Diseases Laryngopharyngeal Reflux Respiratory Tract Diseases

Age range

5 day–5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ospedale Pediatrico Giovanni XXIII

Bari, BA, 70100, Italy

About this study

The primary objective of this trial is to show that the test formula (HA formula + starch + L. reuteri) decreases the severity (frequency + volume) of regurgitation/spitting-up in infants and ultrasound gastric emptying time, compared to a classical infant starter formula.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
  • Age of infant between 5 days and 5 months
  • NGA
  • Infant exclusively formula-fed at enrollment
  • Presenting regurgitation/spitting-up according to the parents' perception
  • Vandenplas score of at least 2 and maximum 5
  • Having obtained the subject's legal representative's written informed consent

Exclusion criteria

  • Previous antireflux treatment
  • Previous consumption of AR infant formula or external thickener
  • Previous consumption of a formula with L. reuteri
  • Cow's milk allergy symptoms according to medical decision
  • Congenital illness or malformation that may affect growth
  • Significant pre-natal and/or post-natal disease
  • Newborn whose parents / caregivers cannot be expected to comply with study procedures
  • Newborn currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.

Treatment and study plan

HA formula + starch + L. reuteri

Dietary Supplement

Primary outcomes

  1. Regurgitation

    Time frame: four weeks of treatment

    The primary outcome is the difference in the proportions of improved subjects at four weeks of treatment between the treatment and control groups.

Secondary outcomes

  1. Growth

    Time frame: Four weeks of treatment

    To assess whether the groups have comparable growth

  2. Regurgitation score

    Time frame: Four weeks treatment

    To assess the severity of regurgitation/spitting-up To assess the frequency of regurgitation/spitting-up To assess the volume of regurgitation/spitting-up

  3. Gastric empty rate

    Time frame: Four week treatment

    To compare the ultrasound gastric empty rate

  4. Digestive tolerance

    Time frame: Four weeks treatment

    To assess the infants' digestive tolerance

  5. Stool frequency

    Time frame: Four weeks treatment

    To assess stool frequency

  6. compliance

    Time frame: four weeks intervention

    To assess the subject's compliance to product consumption.

  7. Financial and non-financial burden

    Time frame: Four week treatment

    To measure family financial and non-financial burden related with the regurgitation

Sponsors and collaborators

Lead sponsor

University of Bari

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 8, 2013
Registry last updated
Apr 1, 2015

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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