Regurgitation, GastricLeopardNCT03371615
Evaluation of the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula
A study testing Anti-regurgitation infant formula in people with Regurgitation, Gastric, run by Nutricia Research at 2 sites in Poland.
Trial summary
A randomised, controlled, double-blind trial to evaluate the tolerance and safety of a new partly fermented anti-regurgitation infant formula containing prebiotics and locust bean gum in infants with regurgitation. Read more about this study
- Who is it for?
- Ages 3 to 13 weeksHealthy volunteers can take part
- Conditions the study is for
- Regurgitation, Gastric
- What is being tested?
- Anti-regurgitation infant formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 2 sitesPoland
- Study dates
- 4 Nov 2017to 6 Sep 2019
- 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 13 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton healthy term infant aged 3 - 13 weeks;
- Gestational age at birth 37- 42 weeks;
- Normal birth weight for gestational age and gender i.e. 10th to 90th percentile compared to the WHO or local growth charts;
- Infants with regurgitation that are otherwise healthy, based upon the following criteria: 1) Regurgitation of 2 or more times per day for 1 or more weeks according to reported history, 2) an indication for the use of AR formula according to the investigator at screening/randomisation.
- Fully formula fed for at least 7 days before screening/randomisation;
- Written informed consent from the parent(s) and/or legally acceptable representative(s), aged ≥ 18 years.
- -
Who cannot join
- 1. History of retching, hematemesis, aspiration, apnoea, failure to thrive, feeding or swallowing difficulties or abnormal posturing; 2. Gastrointestinal infection within 4 weeks prior to randomisation; 3. Congenital condition and/or previous or current illness and (or) medication use that could interfere with the main study outcomes according to the investigator; 4. Known cow's milk protein allergy, lactose intolerance, or galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients (especially scGOS); 5. Presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement; 6. Received any of the following products/medication prior to randomisation: systemic antibiotics, prokinetics, proton pump inhibitors, complementary feeding/weaning within 4 weeks prior to randomisation; 7. 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; 8. Current participation in another clinical intervention study.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K
Bialystok, 15-435
Centrum Medyczne Promed
Krakow, 31411
About this study
Official title: A Randomised, Controlled, Double Blind Trial to Evaluate the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula Containing Prebiotics and Locust Bean Gum in Infants With Regurgitation.
A randomised, controlled, double-blind trial to evaluate the tolerance and safety of a new partly fermented anti-regurgitation infant formula containing prebiotics and locust bean gum in infants with regurgitation.
- Conditions
- Regurgitation, Gastric
- Being tested
- Anti-regurgitation infant formula
- Medical subject headings
- Laryngopharyngeal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-regurgitation infant formulaOther
Anti regurgitation infant formula
| Study group | Role | What they receive |
|---|---|---|
| Fermented IF + LBG + Gos Fos | Active comparator | Fermented infant formula with Locust bean gum and Gos Fos Receives: Other: Anti-regurgitation infant formula |
| Fermented IF +LBG | Placebo comparator | Fermented infant formula with Locust bean gum Receives: Other: Anti-regurgitation infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI tolerance
To assess the gastrointestinal (GI) tolerance of the investigational product compared to the control product based on Infant Gastrointestinal Symptom Questionnaire(IGSQ) symptoms score containg 13 questions on a 7 point scale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start4 Nov 2017
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 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
- NCT03371615
- Sponsor's protocol ID
- EBB16GL10424
- Acronym
- Leopard
- Status last verified
- Nov 2019
- First submitted
- 24 Oct 2017
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bellaiche M, Ludwig T, Arciszewska M, Bongers A, Gomes C, Swiat A, Dakhlia F, Piollet A, Oozeer R, Vandenplas Y. Safety and Tolerance of a Novel Anti-Regurgitation Formula: A Double-Blind, Randomized, Controlled Trial. J Pediatr Gastroenterol Nutr. 2021 Nov 1;73(5):579-585. doi: 10.1097/MPG.0000000000003289.
PubMed 34417399
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Double Blind Trial to Evaluate the Tolerance and Safety of a New Partly Fermented Anti-regurgitation Infant Formula Containing Prebiotics and Locust Bean Gum in Infants With Regurgitation.
- ClinicalTrials.gov ID
- NCT03371615
- Acronym / sponsor ID
- Leopard / EBB16GL10424
- Conditions
- Regurgitation, Gastric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2017 (actual)
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 13 Dec 2017 (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 randomised, controlled, double-blind trial to evaluate the tolerance and safety of a new partly fermented anti-regurgitation infant formula containing prebiotics and locust bean gum in infants with regurgitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fermented IF + LBG + Gos Fos | Active comparator | Other: Anti-regurgitation infant formulaFermented infant formula with Locust bean gum and Gos Fos |
| Fermented IF +LBG | Placebo comparator | Other: Anti-regurgitation infant formulaFermented infant formula with Locust bean gum |
Who may qualify
- Ages
- 3 to 13 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Singleton healthy term infant aged 3 - 13 weeks;
- Gestational age at birth 37- 42 weeks;
- Normal birth weight for gestational age and gender i.e. 10th to 90th percentile compared to the WHO or local growth charts;
- Infants with regurgitation that are otherwise healthy, based upon the following criteria: 1) Regurgitation of 2 or more times per day for 1 or more weeks according to reported history, 2) an indication for the use of AR formula according to the investigator at screening/randomisation.
- Fully formula fed for at least 7 days before screening/randomisation;
Key exclusion criteria (1 listed)
- 1. History of retching, hematemesis, aspiration, apnoea, failure to thrive, feeding or swallowing difficulties or abnormal posturing; 2. Gastrointestinal infection within 4 weeks prior to randomisation; 3. Congenital condition and/or previous or current illness and (or) medication use that could interfere with the main study outcomes according to the investigator; 4. Known cow's milk protein allergy, lactose intolerance, or galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients (especially scGOS); 5. Presence of any other gastrointestinal symptom(s)/disorder(s) that are not functional in nature, as assessed by the investigator's clinical judgement; 6. Received any of the following products/medication prior to randomisation: systemic antibiotics, prokinetics, proton pump inhibitors, complementary feeding/weaning within 4 weeks prior to randomisation; 7. 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; 8. Current participation in another clinical intervention study.
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 |
|---|---|---|
| Anti-regurgitation infant formulaAnti regurgitation infant formula | Other | Fermented IF + LBG + Gos Fos, Fermented IF +LBG |
Primary outcome
GI tolerance
Time frame: 4 weeks
To assess the gastrointestinal (GI) tolerance of the investigational product compared to the control product based on Infant Gastrointestinal Symptom Questionnaire(IGSQ) symptoms score containg 13 questions on a 7 point scale
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 30 Dec 2021.
- Background: PubMed 34417399Bellaiche M, Ludwig T, Arciszewska M, Bongers A, Gomes C, Swiat A, Dakhlia F, Piollet A, Oozeer R, Vandenplas Y. Safety and Tolerance of a Novel Anti-Regurgitation Formula: A Double-Blind, Randomized, Controlled Trial. J Pediatr Gastroenterol Nutr. 2021 Nov 1;73(5):579-585. doi: 10.1097/MPG.0000000000003289.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-regurgitation infant formula in people with Regurgitation, Gastric, run by Nutricia Research at 2 sites in Poland.
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 7 inclusion and 1 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 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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. Some participants in this study may receive a placebo. 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?
GI tolerance (time frame: 4 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 NCT03371615, 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 30 Dec 2021.