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New treatment option for Gastroesophageal Reflux
Official title Treatment of Gastroesophageal Reflux Disease in Infants
ClinicalTrials.gov ID: NCT06255886
What this study is testing
What is Protein pump inhibitor.?
Protein pump inhibitor. is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for gastroesophageal reflux.
Also referred to as Omeprazole.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Gastroesophageal reflux disease in infants is not fully understood. Infants are prescribed medical treatments that may not be effective or that contribute to adverse side effects and lead to concerns and expenses for the parents and healthcare system.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 1
You may be able to join if
- Infants diagnosed with gastroesophageal reflux disease (GERD)
- Age \< 1 year at the time of referral
- Age \>1 month at start of treatment
- At least 3 reflux episodes/daily in average
- At least one of following troublesome symptoms are present: Crying of unknown reason, discomfort/irritability, problems gaining weight/ weightloss...
You likely can't join if
- Children with diagnosed or suspected syndrome /genetic disorder
- Congenital malformations (minor deformities are excepted)
- Abdominal surgery
- Metabolic disease
- Treatment with proton pump inhibitor within the last week
- Allergy for proton pump inhibitors
See the full eligibility criteria
- Infants diagnosed with gastroesophageal reflux disease (GERD)
- Age \< 1 year at the time of referral
- Age \>1 month at start of treatment
- At least 3 reflux episodes/daily in average
- At least one of following troublesome symptoms are present: Crying of unknown reason, discomfort/irritability, problems gaining weight/ weightloss, rejects the breast or bottle, apnea, back-arching.
- Children with diagnosed or suspected syndrome /genetic disorder
- Congenital malformations (minor deformities are excepted)
- Abdominal surgery
- Metabolic disease
- Treatment with proton pump inhibitor within the last week
- Allergy for proton pump inhibitors
- Allergy for cow milk protein
- Infants on Cow's milk free diet
The study team makes the final eligibility decision.
Where it's taking place
- Aabenraa, Region Syddanmark, Denmark
- Odense, Region Syddanmark, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 1 year. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aabenraa, Region Syddanmark, Denmark; Odense, Region Syddanmark, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.