Health TrialsbyHealthPanel

Treatment of Gastroesophageal Reflux Disease in Infants

ConditionsGastroesophageal RefluxInfant, Newborn, Diseases
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-1
SponsorOdense University Hospital

About this trial

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. Current guidelines recommend cow-milk-protein free diet as a first-line treatment, but these recommendations are based on weak evidence. This study investigate the efficacy of a cow-milk-protein free diet compared to treatment with a proton pump inhibitor (omeprazole)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Children with diagnosed or suspected syndrome /genetic disorder

Congenital malformations (minor deformities are excepted)

Abdominal surgery

Metabolic disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Protein pump inhibitor.

    Drug

    1 mg/kg /day

  • Mother or infant diet

    Behavioral

    Mother on cow milk protein diet or infant on hypoallergenic formula in case of bottle fed

  • Placebo

    Drug

    Placebo medicine (appearing substantially like Omeprazole) 1mg/ ml, and continuing nutrition containing cows' milk protein

Treatment groups

96 Participants
are divided into 3 treatment groups
Group A: Proton pump inhibitorActive comparator 1 intervention
Group B: Mother or infant dietActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in reflux episodes in the fourth week of active treatment, compared to placebo

Parent-reported reduction in the weekly number of reflux-episodes in the fourth week of active treatment with either PPI or diet, compared to placebo. The outcome is registered daily in an App.

Time frame
Baseline and daily in 4 weeks.

Secondary outcomes

1

Change from baseline in reflux episodes in the fourth week in the PPI group, compared to the diet group.

Reduction in the number of regurgitation episodes (compared to the run-in period) in the PPI group compared to the diet group

Time frame
Baseline and 4 weeks
2

Change from baseline in weight

A nurse or physician will perform the measurement on a weight in the clinic/hospital. Measurement unit: gram.

Time frame
Baseline and 4 weeks
3

Change from baseline in the number of reflux episodes with visible blood

Parent reported weekly number of reflux episodes with visible blood. Registered in MyCap App.

Time frame
1,2,3,4 weeks
4

Change from baseline in the number of episodes with discomfort

Parent reported weekly episodes with discomfort 5 minutes after feeding. Registered in MyCap App

Time frame
1,2,3,4 weeks

Other outcomes

1

Adverse events to trial medicine in the proton pump inhibitor group and the placebo group

Any parent-reported adverse events to the trial medicine (both Omeprazole and placebo) are registered weekly. There are several well-known side effects; 1-10 % experience symptoms from the gastrointestinal tract (i.e., stomach pain, nausea, and constipation), skin, airways, and increased susceptibility to infections.

Time frame
1,2,3,4 weeks
2

Cows milk allergy?

After 4 weeks´ of cows milk protein-free diet, an oral provocation test with cow's milk is conducted on all infants in the diet group, who experienced effect of the diet. The test will be carried out in the hospital. During the test, the infants are given increasing doses of fresh cow's milk every 30 minutes until they reach a maximum of 200 ml. A nurse records any symptoms experienced during the first few hours of the test, and the parents are required to monitor and report any symptoms at home. Additionally, the parents inform the physician of any late symptoms via phone call 48 hours after the test.

Time frame
4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Odense University Hospital

Lead sponsor

Source ClinicalTrials.gov
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