Functional Gastrointestinal DisordersNCT06488274
Evolution of Functional Gastrointestinal Disorders in Infants Fed With a New Infant Formula
A study testing New infant formula in people with Functional Gastrointestinal Disorders, run by United Pharmaceuticals at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- New infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 4 sitesFrance
- Study dates
- 21 Oct 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants presenting with at least one of the FGIDs below, defined based on adapted Rome IV criteria as follows:
- 1.1 Regurgitations: 1.2 Colic: 1.3 Constipation:
- Infants born at 35 weeks or more of gestational age
- Infants up to 4 months of age
Who cannot join
- 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
- Known allergy/intolerance to any of the product ingredients or suspected allergy to cow's milk requiring an eviction diet
- Infants presenting with any other situation including the participation in another clinical trial, which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the patient
- (non exhaustive list)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Site 02
Nice
- Not yet recruiting
Site 04
Paris
- Recruiting
Site 03
Toulon
- Recruiting
Site 01
Vincennes
About this study
Official title: Assessment of the Evolution of functIonal Gastrointestinal Disorders in Infants During Their Dietary Management With a New Infant Formula
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.
Read the detailed description
The study comprises a first period of 30 days followed by an optional intervention period of 90 days.
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- New infant formula
- Keywords
- Regurgitations, Colic, Constipation, Infant formula, GIGER scale, Nutrition, Infants
- Medical subject headings
- Gastrointestinal Diseases, Gastroesophageal Reflux, Colic, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New infant formulaDietary supplement
The new formula will be given to infants during the 4-month study period.
| Study group | Role | What they receive |
|---|---|---|
| Test formula | Experimental | The test product is a thickened infant formula containing symbiotic (fibers and probiotics) Receives: Dietary Supplement: New infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 30
Secondary outcomes (20)
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.
Measured: Day 14, Day 30, Day 60, Day 90, Day 120
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].
Measured: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
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.
Measured: Day 14, Day 30, Day 60, Day 90, Day 120
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).
Measured: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Stool frequency and consistency in constipated infant
If the infant is constipated at one visit during the study, the total number of each stool consistency will be assessed for the next visit based on the BITSS scale over the last 7 days. The total number of stools over the last 7 days will be calculated.
Measured: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Defecation pain frequency in constipated infant
If the infant is constipated at one visit during the study, the frequency of defecation pain will be assessed for the next visit based on a 3-point scale (No; Yes, only 1 time; Yes, >1 time) over the last 7 days.
Measured: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Colic
Colic will be assessed through unexplained crying duration and fussing/irritability duration on average over the last 3 days and reported based on a 4-point scale (< 1h; 1h-2h; 2h-3h; > 3h).
Measured: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Gas/flatulence severity
Gas/flatulence severity will be assessed on average over the last 3 days using a visual analog scale (from 0=No symptom to 10=Very severe symptoms).
Measured: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Abdominal distension severity
Abdominal distension is defined as a swollen, tense and hard to the touch stomach. Its severity will be assessed on average over the last 3 days using a visual analog scale (from 0=No symptom to 10=Very severe symptoms).
Measured: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
GIGER score
Evolution of Gastrointestinal and Gastroesophageal Reflux (GIGER) scale total score (from 0 to 180) and 3 subscores (subscore 1: from 0 to 75; subscore 2: from 0 to 65; subscore 3: from 0 to 40) from baseline. The higher the GIGER is, the worst the symptoms are.
Measured: Day 7, Day 14, Day 60, Day 90, Day 120
Investigator's evaluation of the evolution of FGIDs
The investigator will evaluate the evolution of each FGID (i.e. regurgitations, constipation, colic) using a 4-point scale (Improvement; Worsening; No evolution; Not applicable) over the past period.
Measured: Day 14, Day 30, Day 60, Day 90, Day 120
Number of bottles at night
The number of bottles at night will be recorded on average over the last 3 days.
Measured: D7, D14, D30, D60, D90, D120
Sleep
The average sleep duration will be reported over the last 3 days and sleep quality will be assessed using a visual analog scale (from 0= Difficult to fall asleep, frequent awakenings to 10= Easy and quick falling asleep, no awakenings without obvious cause).
Measured: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Infant's quality of life
Parents will complete the QUALIN questionnaire (score from -68 to +68) (Manificat et al., 2000) over the last week.
Measured: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Weight
Weight will be expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards.
Measured: Day 30, Day 60, Day 90, Day 120
Height
Height will be expressed in cm and in z scores according to the WHO Child Growth Standards.
Measured: Day 30, Day 60, Day 90, Day 120
Head circumference
Head circumference will be expressed in cm and in z scores according to the WHO Child Growth Standards.
Measured: Day 30, Day 60, Day 90, Day 120
BMI
BMI will be expressed in value and z scores according to the WHO Child Growth Standards.
Measured: Day 30, Day 60, Day 90, Day 120
Adverse events
Any untoward medical reaction occuring from the signatture of the consent until the end of the participant's participation
Measured: Through study completion (up to 30 days or 120 days if participation to the optional intervention period)
Parents' satisfaction
Parents' satisfaction will be assessed on the product use and acceptability using a 5-point Likert scale and more specifically on the evolution of each FGID (i.e. regurgitations, constipation, colic) using a 4-point scale (Improvement; Worsening; No evolution; Not applicable) over the past period.
Measured: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start21 Oct 2024
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional, open-label, non-comparative multicenter study
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Axiodis CRO
- Responsible party
- Sponsor
- Investigators
- Christophe Batard, Dr., Study director, Ambulatory pediatrician in Vincennes (France)Camille Jung, Prof., Study chair, Centre Hospitalier Intercommunal (CHI) in Créteil (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488274
- Sponsor's protocol ID
- UP2022_FGID
- Status last verified
- Jan 2025
- First submitted
- 21 Jun 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pados BF, Repsha C, Hill RR. The Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infants and Toddlers. Glob Pediatr Health. 2021 Jul 14;8:2333794X211033130. doi: 10.1177/2333794X211033130. eCollection 2021.
PubMed 34350308Vandenplas Y, Hachimi-Idrissi S, Casteels A, Mahler T, Loeb H. A clinical trial with an "anti-regurgitation" formula. Eur J Pediatr. 1994 Jun;153(6):419-23. doi: 10.1007/BF01983405.
PubMed 8088297Huysentruyt K, Koppen I, Benninga M, Cattaert T, Cheng J, De Geyter C, Faure C, Gottrand F, Hegar B, Hojsak I, Miqdady M, Osatakul S, Ribes-Koninckx C, Salvatore S, Saps M, Shamir R, Staiano A, Szajewska H, Vieira M, Vandenplas Y; BITSS working group. The Brussels Infant and Toddler Stool Scale: A Study on Interobserver Reliability. J Pediatr Gastroenterol Nutr. 2019 Feb;68(2):207-213. doi: 10.1097/MPG.0000000000002153.
PubMed 30672767Manificat S, Dazord A, Langue J, Danjou G, Bauche P, Bovet F, Cubells J, Luchelli R, Tockert E, Conway K. [Evaluation of the quality of life of infants and very young children: validation of a questionnaire. Multicenter European study]. Arch Pediatr. 2000 Jun;7(6):605-14. doi: 10.1016/s0929-693x(00)80127-x. French.
PubMed 10911526
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Evolution of functIonal Gastrointestinal Disorders in Infants During Their Dietary Management With a New Infant Formula
- ClinicalTrials.gov ID
- NCT06488274
- Acronym / sponsor ID
- UP2022_FGID
- Conditions
- Functional Gastrointestinal Disorders
- Keywords
- Regurgitations, Colic, Constipation, Infant formula, GIGER scale, Nutrition, Infants
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- United PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Axiodis CRO
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study comprises a first period of 30 days followed by an optional intervention period of 90 days.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional, open-label, non-comparative multicenter study
| Arm | Type | Receives |
|---|---|---|
| Test formula | Experimental | Dietary Supplement: New infant formulaThe test product is a thickened infant formula containing symbiotic (fibers and probiotics) |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants presenting with at least one of the FGIDs below, defined based on adapted Rome IV criteria as follows:
- Infants born at 35 weeks or more of gestational age
- Infants up to 4 months of age
Key exclusion criteria (7 listed)
- Exclusively or partially breastfed infants (i.e. \&amp;gt; 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
- Known allergy/intolerance to any of the product ingredients or suspected allergy to cow's milk requiring an eviction diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New infant formulaThe new formula will be given to infants during the 4-month study period. | Dietary supplement | Test formula |
Primary outcome
Change from baseline of the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale score
Time frame: Day 30
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.
20 secondary outcomes
Evolution of FGIDs (regurgitations, colic and constipation)
Time frame: Day 14, Day 30, Day 60, Day 90, Day 120
Regurgitation frequency
Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Regurgitation severity
Time frame: Day 14, Day 30, Day 60, Day 90, Day 120
Stool frequency and consistency in non constipated infant
Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Stool frequency and consistency in constipated infant
Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Defecation pain frequency in constipated infant
Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Colic
Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Gas/flatulence severity
Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Abdominal distension severity
Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
GIGER score
Time frame: Day 7, Day 14, Day 60, Day 90, Day 120
Investigator's evaluation of the evolution of FGIDs
Time frame: Day 14, Day 30, Day 60, Day 90, Day 120
Number of bottles at night
Time frame: D7, D14, D30, D60, D90, D120
Sleep
Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Infant's quality of life
Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Weight
Time frame: Day 30, Day 60, Day 90, Day 120
Height
Time frame: Day 30, Day 60, Day 90, Day 120
Head circumference
Time frame: Day 30, Day 60, Day 90, Day 120
BMI
Time frame: Day 30, Day 60, Day 90, Day 120
Adverse events
Time frame: Through study completion (up to 30 days or 120 days if participation to the optional intervention period)
Parents' satisfaction
Time frame: Day 7, Day 14, Day 30, Day 60, Day 90, Day 120
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Background: PubMed 34350308Pados BF, Repsha C, Hill RR. The Gastrointestinal and Gastroesophageal Reflux (GIGER) Scale for Infants and Toddlers. Glob Pediatr Health. 2021 Jul 14;8:2333794X211033130. doi: 10.1177/2333794X211033130. eCollection 2021.
- Background: PubMed 8088297Vandenplas Y, Hachimi-Idrissi S, Casteels A, Mahler T, Loeb H. A clinical trial with an "anti-regurgitation" formula. Eur J Pediatr. 1994 Jun;153(6):419-23. doi: 10.1007/BF01983405.
- Background: PubMed 30672767Huysentruyt K, Koppen I, Benninga M, Cattaert T, Cheng J, De Geyter C, Faure C, Gottrand F, Hegar B, Hojsak I, Miqdady M, Osatakul S, Ribes-Koninckx C, Salvatore S, Saps M, Shamir R, Staiano A, Szajewska H, Vieira M, Vandenplas Y; BITSS working group. The Brussels Infant and Toddler Stool Scale: A Study on Interobserver Reliability. J Pediatr Gastroenterol Nutr. 2019 Feb;68(2):207-213. doi: 10.1097/MPG.0000000000002153.
- Background: PubMed 10911526Manificat S, Dazord A, Langue J, Danjou G, Bauche P, Bovet F, Cubells J, Luchelli R, Tockert E, Conway K. [Evaluation of the quality of life of infants and very young children: validation of a questionnaire. Multicenter European study]. Arch Pediatr. 2000 Jun;7(6):605-14. doi: 10.1016/s0929-693x(00)80127-x. French.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christophe Batard, Dr. study director
Ambulatory pediatrician in Vincennes (France)
Camille Jung, Prof. study chair
Centre Hospitalier Intercommunal (CHI) in Créteil (France)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New infant formula in people with Functional Gastrointestinal Disorders, run by United Pharmaceuticals at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne-Sophie Garreau (0033-155372222, as.garreau@novalac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of the Gastrointestinal and Gastroesophageal Reflux (GIGER) scale score (time frame: Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06488274, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.