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Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula

ConditionFunctional Gastrointestinal Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 4
SponsorUnited Pharmaceuticals

About this trial

This study aims to assess the evolution of functional gastrointestinal disorders (FGIDs) in infants fed with a new infant formula, using the Gastrointestinal (GI) and gastroesophageal reflux (GER) (GIGER) scale through an interventional, open-label, non-comparative multicenter study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Infants born at 35 weeks or more of gestational age

Infants up to 4 months of age

Disqualifiers

Exclusively or partially breastfed infants (i.e. > 2 breast feeds per day) with maternal willingness to continue breastfeeding

Diversified infants or whose parents intend to start diversification within the first 2 weeks of the study

Use of antibiotics at inclusion visit (V0) and within 7 days before the inclusion visit (V0)

The willingness to take additional pre-, probiotics or thickening agents during the study

Trial design

Design model

Single group

Treatments tested in this trial

  • New infant formula

    Dietary supplement

    The new formula will be given to infants during the 4-month study period.

Treatment groups

139 Participants
are divided into 1 treatment group
Group A: Test formulaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline of the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale score

The main outcome will be the evolution of the sum score of the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale (Pados et al., 2021). The GIGER score varies from 0 to 180 being the worst.

Time frame
Day 30

Secondary outcomes

1

Evolution of FGIDs (regurgitations, colic and constipation)

FGIDs such as regurgitation, colic and constipation will be assessed according to adapted Rome IV criteria. The improvement and complete resolution timeframe of each FGID present at inclusion and/or occurring during the study will be determined.

Time frame
Day 14, Day 30, Day 60, Day 90, Day 120
2

Regurgitation frequency

The number of daily regurgitation episodes and the daily volume of regurgitation will be assessed on average over the last 3 days. The frequency of regurgitations away from meals and of continuous regurgitations of small volumes after feeding will be assessed on average over the last 3 days via a 4-point scale \[Never; Rarely; Often; Always\].

Time frame
Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
3

Regurgitation severity

The regurgitation severity will be assessed using the adapted Vandenplas regurgitation score (from 0 to 6 being the worst) (Vandenplas et al., 1994) over the last 3 days preceding each visit.

Time frame
Day 14, Day 30, Day 60, Day 90, Day 120
4

Stool frequency and consistency in non constipated infant

If the infant is not constipated at inclusion and during the study, the average main stool consistency will be assessed based on the BITSS scale (Brussels Infant and Toddler Stool Scale) as well as the daily average number of stools over the last 3 days. The BITTS scale is a reliable instrument to assess stools of non-toilet trained children. It consists of 7 color photographs of diapers containing stools from infants and toddlers categorized as Hard, Formed, Loose, or Watery (Huysentruyt et al., 2019).

Time frame
Day 7, Day 14, Day 30, Day 60, Day 90, Day 120

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

United Pharmaceuticals

Lead sponsor

Axiodis CRO

Collaborator

Source ClinicalTrials.gov
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