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OpenTrials
Completed

NCT Number: NCT02425423

Study on the Tolerance and Efficacy of a New Anti Regurgitation Formula

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

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Key information

Conditions

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

Age range

Up to 5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pediatricians, Belgium

Loading trial locations.

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

Exclusion criteria

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

Treatment and study plan

New thickened formula

Dietary Supplement

Primary outcomes

  1. Number of episodes of regurgitation per day

    Time frame: 14 days

Secondary outcomes

  1. Regurgitation score

    Time frame: 14 days

  2. Regurgitation score

    Time frame: 3 months

  3. Digestive tolerance (stools' number and consistency)

    Time frame: 14 days

    Digestive tolerance of the formula assessed through stools' number and consistency

  4. Digestive tolerance (stools' number and consistency)

    Time frame: 3 months

    Digestive tolerance of the formula assessed through stools' number and consistency

  5. Growth parameters (Weight, height and head circumference)

    Time frame: 3 months

    Weight, height and head circumference

Sponsors and collaborators

Lead sponsor

United Pharmaceuticals

Industry

Registry information

Acronym: SONAR

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 24, 2015
Registry last updated
Apr 24, 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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