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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04358146

Acronym

STELLAR

Enrollment

346

Registered

2020-04-24

Start date

2020-07-01

Completion date

2022-03-01

Last updated

2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux in Children

Keywords

Reflux

Brief summary

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.

Detailed description

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).

Interventions

OTHERExperimental Infant formula

Exclusive formula feeding with the new infant formula thickened with fibers

OTHERInfant formula thickened with locust bean gum

Exclusive formula feeding with the formula thickened with locust bean

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Weeks to 4 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Frequency of regurgitation	Day 14	Decrease of the daily number of regurgitation between baseline and day 14

Contacts

Primary ContactBastian CUMINAL

b.cuminal@novalac.com0033155372222

Backup ContactANNE-SOPHIE GARREAU

as.garreau@novalac.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026