NCT04358146

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
4 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Mar 2023Dec 2026

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
2.9 years until next milestone

Study Start

First participant enrolled

March 17, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

April 21, 2020

Last Update Submit

April 30, 2026

Conditions

Gastroesophageal Reflux in Children

Keywords

Reflux

Outcome Measures

Primary Outcomes (1)

  • Frequency of regurgitation

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

    Day 14

Secondary Outcomes (20)

  • Frequency of regurgitations

    Day 30, Day 90

  • Severity of regurgitation episodes

    Day 14, Day 30, Day 90

  • Stools' frequency

    Day 14, Day 30, Day 90

  • Stools' consistency

    Day 14, Day 30, Day 90

  • Frequency of diarrhea

    Day 14, Day 30, Day 90

  • +15 more secondary outcomes

Study Arms (2)

Test

EXPERIMENTAL

new thickened infant formula containing fibres

Other: Experimental Infant formula

Control

ACTIVE COMPARATOR

infant formula thickened with locust bean

Other: Infant formula thickened with locust bean gum

Interventions

Experimental Infant formulaOTHER

Exclusive formula feeding with the new infant formula thickened with fibers

Test
Infant formula thickened with locust bean gumOTHER

Exclusive formula feeding with the formula thickened with locust bean

Control

Eligibility Criteria

Age2 Weeks - 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • preterm infants or birthweight \<2500g
  • Post enteritis lactose intolerance
  • Suspected or diagnosed cow's milk protein allergy requiring an eviction diet
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Center_14

Namur, Belgium

ACTIVE NOT RECRUITING

Center_15

Thuin, Belgium

RECRUITING

Center_09

Castelnau-le-Lez, France

ACTIVE NOT RECRUITING

Center_02

Étampes, France

RECRUITING

Center_05

Libourne, France

RECRUITING

Centre_10

Maromme, France

RECRUITING

Center_16

Nice, France

RECRUITING

Center_08

Vincennes, France

RECRUITING

Center_01

Athens, Greece

RECRUITING

Center_11

Thessaloniki, Greece

RECRUITING

Center_12

Naples, Italy

RECRUITING

Center_13

Naples, Italy

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

locust bean gum

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Magalie JEGAT

CONTACT

+330155372222m.jegat@novalac.com

ANNE-SOPHIE GARREAU

CONTACT

as.garreau@novalac.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

March 17, 2023

Primary Completion (Estimated)

December 3, 2026

Study Completion (Estimated)

December 3, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)IT(2)GR(2)FR(6)