Back to resultsTo Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation (Solar)
Primary Purpose
Regurgitation, Gastric, Diarrhea
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
milk based anti-regurgitation infant formula
Milk based infant formula
Sponsored by
About this trial
This is an interventional treatment trial for Regurgitation, Gastric
Eligibility Criteria
Inclusion Criteria:
- Singleton infants with regurgitation who are otherwise healthy
- Diagnosed with regurgitation according to the (adapted) Rome IV diagnostic criteria.
- Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days
- Aged > 3 weeks (21 days) and < 9 weeks (63 days) at screening
- Exclusively formula fed for ≥ 7 days before screening
- Written informed consent from the parent(s) and/or legally acceptable representative(s)
Exclusion Criteria:
- Low birth weight for gestational age and gender
- Infants diagnosed with or suspected to have gastroesophageal reflux disease (GERD). I
- Infants who received any of the following medication within 4 weeks prior to screening: systemic antibiotics, prokinetics and/or proton pump inhibitors and/or (other) medication to treat regurgitation
- Infants who already consumed a thickened anti-regurgitation (AR) formula or used thickening supplements
- Infants who already started complementary feeding
- Infants with a gastrointestinal infection within 4 weeks prior to screening
- Infants with a congenital condition, previous or current illness, and/or medication use that could interfere with the main study outcomes according to the investigator
- Infants known or suspected to have: allergy for fish, soy protein, soy oil or corn; lactose intolerance; galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients and/or requiring a fibre-free diet
- Infants known or suspected to have allergy to cow's milk protein
- Presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement
- Participation in any other studies involving investigational or marketed products concomitantly or prior to screening
- Incapability of the parent(s) to comply with the study protocol or investigator's uncertainty about the willingness or ability of the parent(s) to comply with the protocol requirements
Sites / Locations
- A.O.U. Ospedali Riuniti di Ancona
- Ospedale pediatrico Giovanni XXIII
- Azienda Ospedaliera Universitaria G. Martino
- Ospedale dei bambini Buzzi
- Ospedale F. Del Ponte
- Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k.
- Osrodek badan Klinicznych IN-VIVO sp. z o.o.
- Gabinet Lekarski
- NZLA Michalkowice Jarosz
- Alergo-Med Specjalistyczna Przychodnia Lekarska sp. z o.o
- EPOKA Niepubliczny Zaklad Opieki Zdrowotnej Piotr Chodkiewicz Sp. z o.o
- Communal Nonprofit Enterprise "City Children's Clinical Hospital
- Communal Nonprofit Enterprise "City Children's Clinical Hospital
- Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital"
- Communal Enterprise "Poltava Regional Children's Clinical Hospital of Poltava Regional Council
- Communal Non-Profit Enterprise of Sumy Regional Council "Regional Children Clinical Hospita
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test Product
Control Product
Arm Description
Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics
Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics
Outcomes
Primary Outcome Measures
Average stool consistency
The average stool consistency (based on the 4-point Brussels Infant and Toddler Stool Scale [BITSS]) of the 8th week of intervention, adjusted for the baseline stool consistency score. Catagories are hard stools, formed stools, loose stools and watery stools. https://bitss-stoolscale.com/ (assessed 31-Jan-19) can be used as a further reference.
Secondary Outcome Measures
To assess the average stool consistency
The average stool consistency based on the BITSS, adjusted for baseline, for every week until the 8th week of intervention and for the week prior to the age of 17 weeks
The average stool frequency
The average stool frequency, adjusted for baseline, for every week until and including the 8th week of intervention and for the week prior to the age of 17 weeks
Incidence of diarrhoea:
based on the WHO criteria and derived from the BITSS, for every week (until and including week 8 of intervention, and at the age of 17 weeks)
based on investigator's diagnosis of diarrhoea (throughout the entire study)
IGSQ sum and individual item scores
IGSQ sum and individual item scores, adjusted for baseline, at 2, 4 and 8 weeks of intervention, and at the age of 17 weeks
Gut microbiota composition and function
Gut microbiota composition and function (acetate, lactate, pH, calprotectin, ammonium and sIgA) at baseline and at the age of 17 weeks
Regurgitation
Regurgitation: number of regurgitation episodes per day and the regurgitation volume score, adjusted for baseline, at 2, 4 and 8 weeks of intervention, and at the age of 17 weeks (based on 3-day diaries)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04042454
Brief Title
To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation
Acronym
Solar
Official Title
A Randomized, Controlled Study to Evaluate the Safety and Tolerance of an Infant Formula With Locust Bean Gum in Infants With Regurgitation
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
May 23, 2023 (Actual)
Study Completion Date
May 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutricia Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regurgitation, Gastric, Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test Product
Arm Type
Experimental
Arm Description
Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics
Arm Title
Control Product
Arm Type
Active Comparator
Arm Description
Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics
Intervention Type
Other
Intervention Name(s)
milk based anti-regurgitation infant formula
Intervention Description
Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.
Intervention Type
Other
Intervention Name(s)
Milk based infant formula
Intervention Description
Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.
Primary Outcome Measure Information:
Title
Average stool consistency
Description
The average stool consistency (based on the 4-point Brussels Infant and Toddler Stool Scale [BITSS]) of the 8th week of intervention, adjusted for the baseline stool consistency score. Catagories are hard stools, formed stools, loose stools and watery stools. https://bitss-stoolscale.com/ (assessed 31-Jan-19) can be used as a further reference.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
To assess the average stool consistency
Description
The average stool consistency based on the BITSS, adjusted for baseline, for every week until the 8th week of intervention and for the week prior to the age of 17 weeks
Time Frame
8 weeks
Title
The average stool frequency
Description
The average stool frequency, adjusted for baseline, for every week until and including the 8th week of intervention and for the week prior to the age of 17 weeks
Time Frame
8 weeks
Title
Incidence of diarrhoea:
Description
based on the WHO criteria and derived from the BITSS, for every week (until and including week 8 of intervention, and at the age of 17 weeks)
based on investigator's diagnosis of diarrhoea (throughout the entire study)
Time Frame
8 weeks, 17 weeks
Title
IGSQ sum and individual item scores
Description
IGSQ sum and individual item scores, adjusted for baseline, at 2, 4 and 8 weeks of intervention, and at the age of 17 weeks
Time Frame
2, 4, 8, 17 weeks
Title
Gut microbiota composition and function
Description
Gut microbiota composition and function (acetate, lactate, pH, calprotectin, ammonium and sIgA) at baseline and at the age of 17 weeks
Time Frame
17 weeks
Title
Regurgitation
Description
Regurgitation: number of regurgitation episodes per day and the regurgitation volume score, adjusted for baseline, at 2, 4 and 8 weeks of intervention, and at the age of 17 weeks (based on 3-day diaries)
Time Frame
2,4,8,17 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Weeks
Maximum Age & Unit of Time
9 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Singleton infants with regurgitation who are otherwise healthy
Diagnosed with regurgitation according to the (adapted) Rome IV diagnostic criteria.
Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days
Aged > 3 weeks (21 days) and < 9 weeks (63 days) at screening
Exclusively formula fed for ≥ 7 days before screening
Written informed consent from the parent(s) and/or legally acceptable representative(s)
Exclusion Criteria:
Low birth weight for gestational age and gender
Infants diagnosed with or suspected to have gastroesophageal reflux disease (GERD). I
Infants who received any of the following medication within 4 weeks prior to screening: systemic antibiotics, prokinetics and/or proton pump inhibitors and/or (other) medication to treat regurgitation
Infants who already consumed a thickened anti-regurgitation (AR) formula or used thickening supplements
Infants who already started complementary feeding
Infants with a gastrointestinal infection within 4 weeks prior to screening
Infants with a congenital condition, previous or current illness, and/or medication use that could interfere with the main study outcomes according to the investigator
Infants known or suspected to have: allergy for fish, soy protein, soy oil or corn; lactose intolerance; galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients and/or requiring a fibre-free diet
Infants known or suspected to have allergy to cow's milk protein
Presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement
Participation in any other studies involving investigational or marketed products concomitantly or prior to screening
Incapability of the parent(s) to comply with the study protocol or investigator's uncertainty about the willingness or ability of the parent(s) to comply with the protocol requirements
Facility Information:
Facility Name
A.O.U. Ospedali Riuniti di Ancona
City
Ancona
Country
Italy
Facility Name
Ospedale pediatrico Giovanni XXIII
City
Bari
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria G. Martino
City
Messina
Country
Italy
Facility Name
Ospedale dei bambini Buzzi
City
Milano
Country
Italy
Facility Name
Ospedale F. Del Ponte
City
Varese
Country
Italy
Facility Name
Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k.
City
Białystok
Country
Poland
Facility Name
Osrodek badan Klinicznych IN-VIVO sp. z o.o.
City
Bydgoszcz
Country
Poland
Facility Name
Gabinet Lekarski
City
Rzeszów
Country
Poland
Facility Name
NZLA Michalkowice Jarosz
City
Siemianowice Śląskie
Country
Poland
Facility Name
Alergo-Med Specjalistyczna Przychodnia Lekarska sp. z o.o
City
Tarnów
Country
Poland
Facility Name
EPOKA Niepubliczny Zaklad Opieki Zdrowotnej Piotr Chodkiewicz Sp. z o.o
City
Żnin
Country
Poland
Facility Name
Communal Nonprofit Enterprise "City Children's Clinical Hospital
City
Dnipro
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise "City Children's Clinical Hospital
City
Kharkiv
Country
Ukraine
Facility Name
Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital"
City
Lviv
Country
Ukraine
Facility Name
Communal Enterprise "Poltava Regional Children's Clinical Hospital of Poltava Regional Council
City
Poltava
Country
Ukraine
Facility Name
Communal Non-Profit Enterprise of Sumy Regional Council "Regional Children Clinical Hospita
City
Sumy
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
37204764
Citation
ESPGHAN 55th Annual Meeting Abstracts. J Pediatr Gastroenterol Nutr. 2023 Jun 1;76(S1 Suppl 1):1-1407. doi: 10.1097/MPG.0000000000003823. Epub 2023 May 19. No abstract available.
Results Reference
result
Learn more about this trial
To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation
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