Regurgitation, GastricPhase 4NCT01956682
Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying
A Phase 4 study testing HA formula + starch + L. reuteri in people with Regurgitation, Gastric, run by University of Bari at 1 site in Italy.
Trial summary
The primary objective of this trial is to show that an hypoallergenic infant starter formula containing starch and the probiotic L. reuteri decreases the severity of regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have taken it for 4 weeks, in comparison with a standard infant… Read more about this study
- Who is it for?
- Ages 5 days to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Regurgitation, Gastric
- What is being tested?
- HA formula + starch + L. reuteri
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2014to Mar 2015
- Phase
- Phase 4
- 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 5 days to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
- Age of infant between 5 days and 5 months
- NGA
- Infant exclusively formula-fed at enrollment
- Presenting regurgitation/spitting-up according to the parents' perception
- Vandenplas score of at least 2 and maximum 5
- Having obtained the subject's legal representative's written informed consent
Who cannot join
- Previous antireflux treatment
- Previous consumption of AR infant formula or external thickener
- Previous consumption of a formula with L. reuteri
- Cow's milk allergy symptoms according to medical decision
- Congenital illness or malformation that may affect growth
- Significant pre-natal and/or post-natal disease
- Newborn whose parents / caregivers cannot be expected to comply with study procedures
- Newborn currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this trial is to show that an hypoallergenic infant starter formula containing starch and the probiotic L. reuteri decreases the severity of regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have taken it for 4 weeks, in comparison with a standard infant starter formula.
Read the detailed description
The primary objective of this trial is to show that the test formula (HA formula + starch + L. reuteri) decreases the severity (frequency + volume) of regurgitation/spitting-up in infants and ultrasound gastric emptying time, compared to a classical infant starter formula.
- Conditions
- Regurgitation, Gastric
- Being tested
- HA formula + starch + L. reuteri
- Medical subject headings
- Laryngopharyngeal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HA formula + starch + L. reuteriDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Infant formula | Active comparator | HA formula + starch + L. reuteri Receives: Dietary Supplement: HA formula + starch + L. reuteri |
| Standard Formula | Placebo comparator | Standard Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regurgitation
The primary outcome is the difference in the proportions of improved subjects at four weeks of treatment between the treatment and control groups.
Measured: four weeks of treatment
Secondary outcomes (7)
Growth
To assess whether the groups have comparable growth
Measured: Four weeks of treatment
Regurgitation score
To assess the severity of regurgitation/spitting-up To assess the frequency of regurgitation/spitting-up To assess the volume of regurgitation/spitting-up
Measured: Four weeks treatment
Gastric empty rate
To compare the ultrasound gastric empty rate
Measured: Four week treatment
Digestive tolerance
To assess the infants' digestive tolerance
Measured: Four weeks treatment
Stool frequency
To assess stool frequency
Measured: Four weeks treatment
compliance
To assess the subject's compliance to product consumption.
Measured: four weeks intervention
Financial and non-financial burden
To measure family financial and non-financial burden related with the regurgitation
Measured: Four week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regurgitation, GastricStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavia Indrio, University of Bari
- Investigators
- Flavia Indrio, MD, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956682
- Sponsor's protocol ID
- University of Bari
- Status last verified
- Mar 2015
- First submitted
- 18 Sep 2013
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying
- ClinicalTrials.gov ID
- NCT01956682
- Acronym / sponsor ID
- University of Bari
- Conditions
- Regurgitation, Gastric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Oct 2013 (estimated)
- 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.
The primary objective of this trial is to show that an hypoallergenic infant starter formula containing starch and the probiotic L. reuteri decreases the severity of regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have taken it for 4 weeks, in comparison with a standard infant starter formula.
Detailed description
The primary objective of this trial is to show that the test formula (HA formula + starch + L. reuteri) decreases the severity (frequency + volume) of regurgitation/spitting-up in infants and ultrasound gastric emptying time, compared to a classical infant starter formula.
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 |
|---|---|---|
| Infant formula | Active comparator | Dietary Supplement: HA formula + starch + L. reuteriHA formula + starch + L. reuteri |
| Standard Formula | Placebo comparator | –Standard Infant Formula |
Who may qualify
- Ages
- 5 days to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Full term infant (37 weeks ≤ gestation ≤ 42 weeks)
- Age of infant between 5 days and 5 months
- NGA
- Infant exclusively formula-fed at enrollment
- Presenting regurgitation/spitting-up according to the parents' perception
Key exclusion criteria (8 listed)
- Previous antireflux treatment
- Previous consumption of AR infant formula or external thickener
- Previous consumption of a formula with L. reuteri
- Cow's milk allergy symptoms according to medical decision
- Congenital illness or malformation that may affect growth
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 |
|---|---|---|
| HA formula + starch + L. reuteri | Dietary supplement | Infant formula |
Primary outcome
Regurgitation
Time frame: four weeks of treatment
The primary outcome is the difference in the proportions of improved subjects at four weeks of treatment between the treatment and control groups.
7 secondary outcomes
Growth
Time frame: Four weeks of treatment
Regurgitation score
Time frame: Four weeks treatment
Gastric empty rate
Time frame: Four week treatment
Digestive tolerance
Time frame: Four weeks treatment
Stool frequency
Time frame: Four weeks treatment
compliance
Time frame: four weeks intervention
Financial and non-financial burden
Time frame: Four week treatment
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 1 Apr 2015.
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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.
Flavia Indrio, MD principal investigator
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HA formula + starch + L. reuteri in people with Regurgitation, Gastric, run by University of Bari at 1 site in Italy.
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 8 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 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Regurgitation (time frame: four weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2015.