Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04358146

Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula (STELLAR)

The aim of the study is to assess the effectiveness of this new formula on regurgitations and secondarily its effect on digestive tolerance through a randomized, controlled, double-blind trial against a comparator.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

2 week–4 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center_14, Namur, Belgium

Loading trial locations.

About this study

The study duration is 1 month and 2 days. It is possible to add 2 additional months (optional).

The 2 first days (from D-3 to D0) correspond to the pre-selection period. These 2 days are followed by the follow-up month (from D0 to D30). It is possible to add an optional follow up of 2 months (form D30 to D90).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥ 2 regurgitation episodes per day during the last 2 weeks and ≥ 4 regurgitation episodes per day in average during the last 2 days,
  • exclusive or predominant formula feeding
  • whose parents signed informed consent

Exclusion criteria

  • preterm infants or birthweight <2500g
  • Post enteritis lactose intolerance
  • Suspected or diagnosed cow's milk protein allergy requiring an eviction diet
  • Use of medications that may interfere with regurgitation or gastrointestinal transit (such as alginates, laxatives, antibiotics...). All these medications have to be stopped at least 7 days before inclusion visit (V1)
  • Infants presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject

Treatment and study plan

Experimental Infant Formula

Other

Exclusive formula feeding with the new infant formula thickened with fibers

Infant formula thickened with locust bean gum

Other

Exclusive formula feeding with the formula thickened with locust bean

Primary outcomes

  1. Frequency of regurgitation

    Time frame: Day 14

    Decrease of the daily number of regurgitation between baseline and day 14

Secondary outcomes

  1. Frequency of regurgitations

    Time frame: Day 30, Day 90

    Change in the daily number of regurgitation between baseline and day 30 / day 90

  2. Severity of regurgitation episodes

    Time frame: Day 14, Day 30, Day 90

    Severity of regurgitations will be assessed using the adapted Vandenplas' score (range: 0 to 6; higher scores indicate more severe regurgitation)

  3. Stools' frequency

    Time frame: Day 14, Day 30, Day 90

    Average daily stool's number

  4. Stools' consistency

    Time frame: Day 14, Day 30, Day 90

    The Amsterdam Infant Stool Scale (AISS) (consistency categories: A [watery] to D [hard]; higher categories indicate firmer stools)

  5. Frequency of diarrhea

    Time frame: Day 14, Day 30, Day 90

    Frequency : Occurence of diarrhea

  6. Severity of diarrhea

    Time frame: Day 14, Day 30, Day 90

    Severity of diarrhea assessed using a study-specific score calculated as the sum of the products of each watery stool and its volume over 2 days (minimum score: 6; no upper limit; higher scores indicate more severe diarrhea)

  7. Frequency of constipation

    Time frame: Day 14, Day 30, Day 90

    Occurence of constipation

  8. Severity of constipation

    Time frame: Day 14, Day 30, Day 90

    Severity of constipation assessed using a study-specific score (range: 1 to 3; higher scores indicate more severe constipation)

  9. Crying time

    Time frame: Day 14, Day 30, Day 90

    Crying time reported by parents in class (Min : Less than 10 min / Max : 3h or more)

  10. Feeding refusal

    Time frame: Day 14, Day 30, Day 90

    Percentage of parents reporting feeding refusal by frequency of occurence (Never / Rarely / Sometimes / Often / Always)

  11. Abnormal posturing

    Time frame: Day 14, Day 30, Day 90

    Percentage of parents reporting abnormal posturing by frequency of occurence (Never / Rarely / Sometimes / Often / Always)

  12. Sleep quality

    Time frame: Day 14, Day 30, Day 90

    Percentage of parents reporting poor sleep quality (Excellent / Good / Fair / Poor)

  13. Anthropometric parameters - Weight

    Time frame: Day 14, Day 30, Day 90

    Body weight measured in kilograms (kg)

  14. Anthropometric parameters - Length

    Time frame: Day 14, Day 30, Day 90

    Body length measured in centimeters (cm)

  15. Anthropometric parameters - Head circumference

    Time frame: Day 14, Day 30, Day 90

    Head circumference measured in centimeters (cm)

  16. Anthropometric parameters - BMI

    Time frame: Day 14, Day 30, Day 90

    Body mass index calculated as kg/m²

  17. Anthropometric parameters - Weight-for-height z-score

    Time frame: Day 14, Day 30, Day 90

    Weight-for-height z-score calculated according to WHO Child Growth Standards

  18. Use of drug treatments

    Time frame: Day 14, Day 30, Day 90

    Frequency of use of proton-pump inhibitors, prokinetics, other GERD treatment

  19. Parents' satisfaction

    Time frame: Day 14, Day 30, Day 90

    Parental satisfaction assessed using a 5-point Likert scale (Very satisfied, Fairly well satisfied, Somewhat dissatisfied, Very dissatisfied, No opinion)

  20. Investigator's satisfaction

    Time frame: Day 14, Day 30, Day 90

    Investigator satisfaction assessed using a 5-point Likert scale (Very satisfied, Fairly well satisfied, Somewhat dissatisfied, Very dissatisfied, No opinion)

Study contacts

Contact information is provided by the study sponsor or research team.

ANNE-SOPHIE GARREAU

CONTACT

[email protected]

Magalie JEGAT

CONTACT

[email protected]

+330155372222

Sponsors and collaborators

Lead sponsor

United Pharmaceuticals

Industry

Collaborators

  • Statitec

Registry information

Official study title

Study on the Efficacy and Tolerance of a New Anti-regurgitation Infant Formula: a Double-blind, Randomized, Controlled, International, Multi-centric Clinical Trial

Acronym: STELLAR

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 24, 2020
Registry last updated
May 4, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.