Regurgitation, GastricSolarNCT04042454
To Assess the Safety and Tolerance of Infant Formula With Locust Bean Gum in Infants With Regurgitation
A study testing milk based anti-regurgitation infant formula and Milk based infant formula in people with Regurgitation, Gastric and Diarrhea, run by Nutricia Research at 16 sites in 3 countries.
Trial summary
A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar) Read more about this study
- Who is it for?
- Ages 3 to 9 weeksHealthy volunteers can take part
- Conditions the study is for
- Regurgitation, Gastric, Diarrhea
- What is being tested?
- milk based anti-regurgitation infant formula and Milk based infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 16 sitesin 3 countries
- Study dates
- 10 Dec 2019to 23 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 9 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Poland6 sites
Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k.
Bialystok
Osrodek badan Klinicznych IN-VIVO sp. z o.o.
Bydgoszcz
Gabinet Lekarski
Rzeszów
NZLA Michalkowice Jarosz
Siemianowice Śląskie
Alergo-Med Specjalistyczna Przychodnia Lekarska sp. z o.o
Tarnów
EPOKA Niepubliczny Zaklad Opieki Zdrowotnej Piotr Chodkiewicz Sp. z o.o
Żnin
Italy5 sites
A.O.U. Ospedali Riuniti di Ancona
Ancona
Ospedale pediatrico Giovanni XXIII
Bari
Azienda Ospedaliera Universitaria G. Martino
Messina
Ospedale dei bambini Buzzi
Milan
Ospedale F. Del Ponte
Varese
Ukraine5 sites
Communal Nonprofit Enterprise "City Children's Clinical Hospital
Dnipro
Communal Nonprofit Enterprise "City Children's Clinical Hospital
Kharkiv
Communal Nonprofit Enterprise "Lviv City Children's Clinical Hospital"
Lviv
Communal Enterprise "Poltava Regional Children's Clinical Hospital of Poltava Regional Council
Poltava
Communal Non-Profit Enterprise of Sumy Regional Council "Regional Children Clinical Hospita
Sumy
About this study
Official title: A Randomized, Controlled Study to Evaluate the Safety and Tolerance of an Infant Formula With Locust Bean Gum in Infants With Regurgitation
A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)
- Conditions
- Regurgitation, Gastric, Diarrhea
- Being tested
- milk based anti-regurgitation infant formula, Milk based infant formula
- Medical subject headings
- Laryngopharyngeal Reflux, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milk based anti-regurgitation infant formulaOther
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.
Milk based infant formulaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Test Product | Experimental | Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics Receives: Other: milk based anti-regurgitation infant formula |
| Control Product | Active comparator | Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics Receives: Other: Milk based infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (6)
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
Measured: 8 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
Measured: 8 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)
Measured: 8 weeks, 17 weeks
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
Measured: 2, 4, 8, 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
Measured: 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)
Measured: 2,4,8,17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start10 Dec 2019
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regurgitation, GastricStudies of the same condition, open and under way.
- More trials run by Nutricia ResearchThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042454
- Sponsor's protocol ID
- EBB18TA19425
- Acronym
- Solar
- Status last verified
- Sep 2021
- First submitted
- 30 Jul 2019
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37204764
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Evaluate the Safety and Tolerance of an Infant Formula With Locust Bean Gum in Infants With Regurgitation
- ClinicalTrials.gov ID
- NCT04042454
- Acronym / sponsor ID
- Solar / EBB18TA19425
- Conditions
- Regurgitation, Gastric, Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 2 Aug 2019 (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.
A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Product | Experimental | Other: milk based anti-regurgitation infant formulaCow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics |
| Control Product | Active comparator | Other: Milk based infant formulaCow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics |
Who may qualify
- Ages
- 3 to 9 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
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 |
|---|---|---|
| milk based anti-regurgitation infant formulaCow'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. | Other | Test Product |
| Milk based infant formulaCow'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. | Other | Control Product |
Primary outcome
Average stool consistency
Time frame: 8 weeks
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.
6 secondary outcomes
To assess the average stool consistency
Time frame: 8 weeks
The average stool frequency
Time frame: 8 weeks
Incidence of diarrhoea:
Time frame: 8 weeks, 17 weeks
IGSQ sum and individual item scores
Time frame: 2, 4, 8, 17 weeks
Gut microbiota composition and function
Time frame: 17 weeks
Regurgitation
Time frame: 2,4,8,17 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Results publication: PubMed 37204764ESPGHAN 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.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing milk based anti-regurgitation infant formula and Milk based infant formula in people with Regurgitation, Gastric and Diarrhea, run by Nutricia Research at 16 sites in 3 countries.
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 6 inclusion and 12 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: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Poland, Italy, Ukraine. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average stool consistency (time frame: 8 weeks). 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 NCT04042454, which also lists 1 linked publication.
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 13 Jul 2023.