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Treatment of Gastroesophageal Reflux Disease in Infants- a Randomized Controlled Trial
EU CTIS ID: 2022-502770-16-00
What this study is testing
To investigate the efficacy of cow's milk-free diet or PPI on Gastroesophageal reflux disease (GERD) in infants <1 year of age, compared to placebo. The primary outcome is the change from baseline in the weekly number of reflux episodes in the active groups compared to the contol group (placebo) in the fourth week of treatment. The parents register the outcome in an App daily.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age under 1 year
- Diagnosed with GERD: 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.
- >1 month old at start of the treatment
You likely can't join if
- Children with a syndrome, or suspected syndrome/genetic disorder
- Metabolic diseases
- Congenital malformations (minor malformations in extremities excluded).
- Abdominal surgery
- Other major diseases (cardial, gastroenterologic, nefrologic, oncologic etc.)
- Prior treatment with PPI (with in the last week)
See the full eligibility criteria
- Age under 1 year
- Diagnosed with GERD: 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.
- >1 month old at start of the treatment
- Children with a syndrome, or suspected syndrome/genetic disorder
- Metabolic diseases
- Congenital malformations (minor malformations in extremities excluded).
- Abdominal surgery
- Other major diseases (cardial, gastroenterologic, nefrologic, oncologic etc.)
- Prior treatment with PPI (with in the last week)
- Allergy to PPI
- Already diagnozed with to cow's milk protein allergy
- Children already on cow's milk free diet
The study team makes the final eligibility decision.
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, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.