The Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infants and Toddlers.
Britt F Pados, Christine Repsha, Rebecca R Hill
https://pubmed.ncbi.nlm.nih.gov/34350308Actively Recruiting
Phase Not Applicable
Age: 0 - 4Months
All Genders
ID06488274
Assessment of the Evolution of Functional Gastrointestinal Disorders in Infants During Their Dietary Management With a New Infant Formula
Led by United Pharmaceuticals · Updated on 2025-01-06
139
Participants Needed
4
Research Sites
17 weeks
Total Duration
On this page
Sponsors
U
United Pharmaceuticals
Lead Sponsor
A
Axiodis CRO
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying infants with functional gastrointestinal disorders (FGIDs) to see how these conditions change when fed a new infant formula. This open-label, interventional, non-comparative multicenter study uses the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale to evaluate symptoms like regurgitations, colic, and constipation. The study focuses on infants up to 4 months old who have at least one FGID based on adapted Rome IV criteria. The study involves feeding infants a thickened infant formula containing fibers and probiotics over two periods: a first 30-day period followed by an optional 90-day intervention period. The new formula is given continuously during the total 4-month study duration. Researchers will monitor various symptoms and digestive functions using the GIGER scale and other assessments throughout these periods. Participants will be evaluated regularly with measures including regurgitation frequency and severity, stool characteristics, colic, gas severity, abdominal distension, sleep quality, infant growth parameters, and quality of life. Parents will also report satisfaction. Safety is monitored by recording any adverse events through study completion. The primary outcome is the change in GIGER score from baseline at Day 30, with ongoing assessments up to Day 120 for those continuing in the optional period.
CONDITIONS
Brief Title
Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula
Who Can Participate
Age: 0 - 4Months
All Genders
Eligibility Criteria
You may qualify if you...
- Infants presenting with at least one functional gastrointestinal disorder such as regurgitations, colic, or constipation based on adapted Rome IV criteria
- Infants born at 35 weeks of gestational age or later
- Infants up to 4 months of age
You will not qualify if you...
- Exclusively or partially breastfed infants receiving more than 2 breast feeds per day with maternal intention to continue breastfeeding
- Infants who are diversified or whose parents intend to start diversification within the first 2 weeks of the study
- Use of antibiotics at the inclusion visit or within 7 days before the inclusion visit
- Willingness to take additional prebiotics, probiotics, or thickening agents during the study
- Known allergy or intolerance to any ingredients of the study product or suspected allergy to cow's milk requiring an eviction diet
- Participation in another clinical trial or any condition that may interfere with study participation or increase risk as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 30 days
Participants receive the new infant formula during the initial 30-day study period.
Visits on Days 7, 14, and 30
Optional Treatment Extension
Duration - 90 days
Participants may continue receiving the new infant formula for an additional 90 days.
Visits on Days 60, 90, and 120
Trial Site Locations
Total: 4 locations
1
Site 02
Nice, France
Not Yet Recruiting
2
Site 04
Paris, France
Not Yet Recruiting
3
Site 03
Toulon, France
Actively Recruiting
4
Site 01
Vincennes, France
Actively Recruiting
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Research Team
A
Anne-Sophie Garreau
C
Caroline Thevret, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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Published Research Related To This Trial
A clinical trial with an "anti-regurgitation" formula.
Y Vandenplas, S Hachimi-Idrissi, A Casteels...
https://pubmed.ncbi.nlm.nih.gov/8088297The Brussels Infant and Toddler Stool Scale: A Study on Interobserver Reliability.
Koen Huysentruyt, Ilan Koppen, Marc Benninga...
https://pubmed.ncbi.nlm.nih.gov/30672767[Evaluation of the quality of life of infants and very young children: validation of a questionnaire. Multicenter European study].
S Manificat, A Dazord, J Langue...
https://pubmed.ncbi.nlm.nih.gov/10911526