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Study on Omeprazole and Cow's Milk-Free Diet for Treating Gastroesophageal Reflux Disease in Infants Under 1 Year

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of Gastroesophageal Reflux Disease (GERD) in infants. GERD is a condition where stomach acid frequently flows back into the tube connecting the mouth and stomach, causing discomfort. The study will also consider infants with a cow's milk allergy, which is an allergic reaction to proteins found in cow's milk. The treatment being tested is a medication called Omeprazole, which is a type of drug known as a proton pump inhibitor. This medication is designed to reduce the amount of acid produced in the stomach. The study will compare the effects of Omeprazole with a placebo, which is a substance with no active medication, to see how effective Omeprazole is in treating GERD in infants.

The purpose of the study is to investigate how well a cow's milk-free diet or Omeprazole works in reducing the symptoms of GERD in infants under one year of age. During the study, parents will be asked to record the number of reflux episodes their child experiences each week using an app. This will help researchers understand how the treatment affects the frequency of reflux episodes. The study will last for several weeks, and parents will be required to monitor and report any changes in their child's symptoms, such as crying, discomfort, or feeding difficulties.

Throughout the study, the safety and any side effects of Omeprazole will be closely monitored. Parents will report any adverse events, such as stomach pain or nausea, that their child may experience. Additionally, the study will assess changes in the child's weight and any signs of improvement in symptoms related to GERD and cow's milk allergy. The trial aims to provide valuable information on the effectiveness of Omeprazole and dietary changes in managing GERD in infants.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the infant must be under 1 year of age and diagnosed with gastroesophageal reflux disease (GERD).

    The infant should experience at least three reflux episodes daily on average, along with symptoms such as unexplained crying, discomfort, weight issues, feeding difficulties, apnea, or back-arching.

  2. Step 2

    Treatment assignment

    The infant will be randomly assigned to one of the treatment groups: a cow's milk-free diet, a proton pump inhibitor (PPI) treatment, or a placebo group.

    The PPI used in the study is omeprazole, administered orally as a powder for suspension.

  3. Step 3

    Treatment administration

    The treatment will last for four weeks.

    Parents will administer the assigned treatment daily, following the specific instructions provided for the group to which the infant is assigned.

  4. Step 4

    Monitoring and reporting

    Parents are required to report the number of reflux episodes and any other symptoms daily using an application.

    Weekly reports will include any adverse events related to the treatment, such as gastrointestinal symptoms, skin reactions, or respiratory issues.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is the change in the weekly number of reflux episodes after four weeks of treatment.

    Secondary outcomes include changes in weight, episodes of visible blood in reflux, crying, feeding refusal, breathing issues, and discomfort.

  6. Step 6

    Dietary assessment

    For infants in the diet group, a cow's milk protein-free diet will be followed for four weeks.

    After this period, an oral provocation test with cow's milk will be conducted to confirm any milk allergy.

  7. Step 7

    Conclusion of the trial

    The trial is expected to conclude by December 31, 2025.

    Final assessments will be made based on the data collected throughout the study period.

Who can join the trial?

9 criteria

  • The child must be under 1 year old.
  • The child must be diagnosed with GERD (Gastroesophageal Reflux Disease), which means having at least 3 reflux episodes on average each day. Additionally, at least one of the following troublesome symptoms must be present:
    • Crying for unknown reasons
    • Discomfort or irritability
    • Problems gaining weight or weight loss
    • Rejecting the breast or bottle
    • Apnea (pauses in breathing)
    • Back-arching
    • The child must be older than 1 month at the start of the treatment.
    • Both male and female infants can participate.

Who cannot join the trial?

3 criteria

  • Infants older than 1 year cannot participate.
  • Infants who do not have **GERD** (Gastroesophageal Reflux Disease) or a **cow's milk allergy** cannot participate.
  • Infants who are not part of the vulnerable population selected for the study cannot participate.
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Investigated drugs

  • Cow's Milk-Free Diet

    is a dietary approach used in the trial to see if removing cow's milk from the diet can help reduce symptoms of gastroesophageal reflux disease (GERD) in infants. This involves feeding the infant with alternatives to cow's milk to see if it decreases the number of reflux episodes.

  • PPI (Proton Pump Inhibitor)

    is a type of medication used in the trial to reduce stomach acid production. By lowering the amount of acid in the stomach, it aims to decrease the frequency and severity of reflux episodes in infants with GERD.

What is already known about the treatment

Proton Pump Inhibitors (PPIs) – These medications are typically administered orally and are used to reduce stomach acid production. They are currently well-established in medical practice and literature for treating conditions like gastroesophageal reflux disease (GERD). The main therapeutic indication for PPIs is to alleviate symptoms of acid reflux and promote healing of the esophagus. At the molecular level, PPIs work by blocking the enzyme system of gastric proton pumps, which are responsible for acid secretion in the stomach. They are classified pharmacologically as acid-reducing agents.

Investigated diseases

  • Gastroesophageal Reflux Disease (GERD)

    This condition occurs when stomach acid frequently flows back into the tube connecting your mouth and stomach, known as the esophagus. This backwash, or acid reflux, can irritate the lining of your esophagus. In infants, GERD can cause symptoms such as frequent vomiting, coughing, and difficulty feeding. Over time, the acid can cause inflammation or damage to the esophagus. The condition is often identified by episodes of discomfort or crying after feeding. It is common in infants and usually improves as they grow older.

  • Cow's Milk Allergy

    This is an allergic reaction to proteins found in cow's milk. It is one of the most common food allergies in infants and young children. Symptoms can include skin reactions, digestive problems, and respiratory issues. The allergy occurs when the immune system mistakenly identifies milk proteins as harmful and triggers an allergic response. It can lead to discomfort and distress in infants, often manifesting as crying, vomiting, or diarrhea. The condition is typically diagnosed through a combination of dietary history and allergy testing.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase ITrial ID2022-502770-16-00Protocol code2022-502770-16-00Estimated enrolment96 patientsSponsorOdense University Hospital

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