Gastroesophageal RefluxPhase 4NCT02806453
Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.
A Phase 4 study testing thickened formula, Mg alginate and reassurance with lifestyle changes in people with Gastroesophageal Reflux, run by Policlinico Hospital at 1 site in Italy.
Trial summary
A randomized controlled cross-over trial in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised). Read more about this study
- Who is it for?
- Ages 3 months to 1 yearHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- thickened formula, Mg alginate and reassurance with lifestyle changes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2016to Dec 2017
- 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 3 months to 1 year
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- full-term ages 3 to 12 months, affected by symptoms suggestive of GER.
- infant regurgitation defined according to the Rome IV criteria
- informed consent
Who cannot join
- Evidence of chronic diseases, hepatic, renal, or cardiac diseases, metabolic or central nervous system diseases, or use of acid suppressor treatment (H2-receptor antagonists or proton pump inhibitors [PPIs]), thickened formula, or a history of prematurity or atopy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Bari, 70124
About this study
A randomized controlled cross-over trial in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised).
The parents of all of the enrolled infants will be reassured on the benign nature of the condition and will advise to apply lifestyle changes for one week.
Than, the patients will be randomized into one of the two sequence treatment groups. (group A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks. Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.
- Conditions
- Gastroesophageal Reflux
- Being tested
- thickened formula, Mg alginate, reassurance with lifestyle changes
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thickened formulaDietary supplement
Mg alginateDietary supplement
reassurance with lifestyle changesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A: Mg alginate/thickened formula Receives: Dietary Supplement: thickened formula; Dietary Supplement: Mg alginate; Behavioral: reassurance with lifestyle changes |
| Group B | Active comparator | Group B: thickened formula/Mg alginate Receives: Dietary Supplement: thickened formula; Dietary Supplement: Mg alginate; Behavioral: reassurance with lifestyle changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of symptom scores
Infant Gastroesophageal Reflux Questionnaire Revised
Measured: From day 0 to day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Maria Elisabetta Baldassarre, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806453
- Sponsor's protocol ID
- ALNEO1
- Status last verified
- Jun 2016
- First submitted
- 16 Jun 2016
- Last updated
- 21 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Alginate on Gastroesophageal Reflux in Infants.
- ClinicalTrials.gov ID
- NCT02806453
- Acronym / sponsor ID
- ALNEO1
- Conditions
- Gastroesophageal Reflux
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Jun 2016 (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.
A randomized controlled cross-over trial in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised).
The parents of all of the enrolled infants will be reassured on the benign nature of the condition and will advise to apply lifestyle changes for one week.
Than, the patients will be randomized into one of the two sequence treatment groups. (group A: Mg alginate/thickened formula; group B: thickened formula/Mg alginate) for two weeks. Evaluation of symptom scores will be performed at day 0, day 7, day 21 and day 35.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Dietary Supplement: thickened formula, Dietary Supplement: Mg alginate, Behavioral: reassurance with lifestyle changesGroup A: Mg alginate/thickened formula |
| Group B | Active comparator | Dietary Supplement: thickened formula, Dietary Supplement: Mg alginate, Behavioral: reassurance with lifestyle changesGroup B: thickened formula/Mg alginate |
Who may qualify
- Ages
- 3 months to 1 year
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- full-term ages 3 to 12 months, affected by symptoms suggestive of GER.
- infant regurgitation defined according to the Rome IV criteria
- informed consent
Key exclusion criteria (1 listed)
- Evidence of chronic diseases, hepatic, renal, or cardiac diseases, metabolic or central nervous system diseases, or use of acid suppressor treatment (H2-receptor antagonists or proton pump inhibitors [PPIs]), thickened formula, or a history of prematurity or atopy
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 |
|---|---|---|
| thickened formula | Dietary supplement | Group A, Group B |
| Mg alginate | Dietary supplement | Group A, Group B |
| reassurance with lifestyle changes | Behavioural | Group A, Group B |
Primary outcome
Evaluation of symptom scores
Time frame: From day 0 to day 35
Infant Gastroesophageal Reflux Questionnaire Revised
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
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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.
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 thickened formula, Mg alginate and reassurance with lifestyle changes in people with Gastroesophageal Reflux, run by Policlinico Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 21 Jun 2016. 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. 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?
Results are not available in the source record.
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?
Evaluation of symptom scores (time frame: From day 0 to day 35). 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 21 Jun 2016.