Gastroesophageal RefluxSWANNCT02710955
SWAN: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)
A study testing Thickened infant formula in people with Gastroesophageal Reflux, run by United Pharmaceuticals at 1 site in Belgium.
Trial summary
The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation Read more about this study
- Who is it for?
- Ages 1 week to 5 months
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Thickened infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2016to 12 Apr 2017
- 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 1 week to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants :
- Aged ≤ 5 months old
- fully formula fed
- with at least 5 episodes of regurgitation per day, for at least a week
Who cannot join
- Breast fed infants
- Infants presenting symptoms of a complicated gastroesophageal reflux
- Infants presenting intestinal disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)
The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation
- Conditions
- Gastroesophageal Reflux
- Being tested
- Thickened infant formula
- 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 infant formulaDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Thickened infant formula | Experimental | Not described Receives: Dietary Supplement: Thickened infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of episodes of regurgitation per day
Measured: 14 days
Secondary outcomes (7)
Regurgitation score assessed through Vandenplas score
Measured: 14 and 90 days
Stools frequency over 72h
Measured: 14 and 90 days
Stools consistency assessed through Bristol Stool form Scale
Measured: 14 and 90 days
Weight expressed in z scores according to the WHO Child Growth Standards
Measured: 90 days
Height expressed in z scores according to the WHO Child Growth Standards
Measured: 90 days
BMI expressed in z scores according to the WHO Child Growth Standards
Measured: 90 days
Head circumference expressed in z scores according to the WHO Child Growth Standards
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study start1 Apr 2016
- Primary completion21 Jan 2017
- Study completion12 Apr 2017
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yvan Vandenplas, MD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710955
- Sponsor's protocol ID
- 2016-01-SWAN
- Acronym
- SWAN
- Status last verified
- May 2017
- First submitted
- 8 Mar 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Tolerance and Efficacy of a New Anti-regurgitation Formula (PC-2016-01)
- ClinicalTrials.gov ID
- NCT02710955
- Acronym / sponsor ID
- SWAN / 2016-01-SWAN
- Conditions
- Gastroesophageal Reflux
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- United PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2016
- Primary completion
- 21 Jan 2017 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 17 Mar 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.
The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thickened infant formula | Experimental | Dietary Supplement: Thickened infant formula |
Who may qualify
- Ages
- 1 week to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants :
Key exclusion criteria (3 listed)
- Breast fed infants
- Infants presenting symptoms of a complicated gastroesophageal reflux
- Infants presenting intestinal disorders
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 infant formula | Dietary supplement | Thickened infant formula |
Primary outcome
Number of episodes of regurgitation per day
Time frame: 14 days
7 secondary outcomes
Regurgitation score assessed through Vandenplas score
Time frame: 14 and 90 days
Stools frequency over 72h
Time frame: 14 and 90 days
Stools consistency assessed through Bristol Stool form Scale
Time frame: 14 and 90 days
Weight expressed in z scores according to the WHO Child Growth Standards
Time frame: 90 days
Height expressed in z scores according to the WHO Child Growth Standards
Time frame: 90 days
BMI expressed in z scores according to the WHO Child Growth Standards
Time frame: 90 days
Head circumference expressed in z scores according to the WHO Child Growth Standards
Time frame: 90 days
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 14 Nov 2017.
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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.
Yvan Vandenplas, MD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thickened infant formula in people with Gastroesophageal Reflux, run by United Pharmaceuticals at 1 site in Belgium.
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 4 inclusion and 3 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 14 Nov 2017. 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 Belgium. 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?
Number of episodes of regurgitation per day (time frame: 14 days). 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 14 Nov 2017.