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Completed

NCT Number: NCT02710955

SWAN: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)

The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation

Completed

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases

Age range

1 week–5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis

Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infants :
  • Aged ≤ 5 months old
  • fully formula fed
  • with at least 5 episodes of regurgitation per day, for at least a week

Exclusion criteria

  • Breast fed infants
  • Infants presenting symptoms of a complicated gastroesophageal reflux
  • Infants presenting intestinal disorders

Treatment and study plan

Thickened infant formula

Dietary Supplement

Primary outcomes

  1. Number of episodes of regurgitation per day

    Time frame: 14 days

Secondary outcomes

  1. Regurgitation score assessed through Vandenplas score

    Time frame: 14 and 90 days

  2. Stools frequency over 72h

    Time frame: 14 and 90 days

  3. Stools consistency assessed through Bristol Stool form Scale

    Time frame: 14 and 90 days

  4. Weight expressed in z scores according to the WHO Child Growth Standards

    Time frame: 90 days

  5. Height expressed in z scores according to the WHO Child Growth Standards

    Time frame: 90 days

  6. BMI expressed in z scores according to the WHO Child Growth Standards

    Time frame: 90 days

  7. Head circumference expressed in z scores according to the WHO Child Growth Standards

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

United Pharmaceuticals

Industry

Registry information

Official study title

Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)

Acronym: SWAN

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2016
Registry last updated
Nov 14, 2017

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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