Treatment of Gastroesophageal Reflux Disease in Infants

NCT06255886 | Recruiting Phase 4

• 1 other identifier: OUH-HCA006
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 3

Brief Summary

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)

Conditions

Gastroesophageal Reflux; Infant, Newborn, Diseases

Keywords

Reflux; Infants; GERD; GER; GORD; GOR; Cow milk protein; Bovine milk protein; CMP; Proton pump inhibitor; PPI; Omeprazole

Outcome Measures

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.

  Baseline and daily in 4 weeks.

Secondary Outcomes (10)

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

  Baseline and 4 weeks

• Change from baseline in weight

  Baseline and 4 weeks

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

  1,2,3,4 weeks

• Change from baseline in the number of episodes with discomfort

  1,2,3,4 weeks

• Change from baseline in the numbers of episodes with crying

  1,2,3,4 weeks

Other Outcomes (2)

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

  1,2,3,4 weeks

• Cows milk allergy?

  4 weeks

Study Arms (3)

Proton pump inhibitor

ACTIVE COMPARATOR

Omeprazole 1 mg/ kg and continuing nutrition containing cow's milk protein

Drug: Protein pump inhibitor.

Mother or infant diet

ACTIVE COMPARATOR

Mother on cow milk-protein-free diet if breastfeeding and infant on a hypoallergenic formula if bottle-fed.

Behavioral: Mother or infant diet

Placebo

PLACEBO COMPARATOR

Placebo medicine (appearing substantially like Omeprazole) 1mg/kg and continuing nutrition containing cow's milk protein

Drug: Placebo

Interventions

Protein pump inhibitor. DRUG

1 mg/kg /day

Also known as: Omeprazole

Proton pump inhibitor

Mother or infant diet BEHAVIORAL

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

Also known as: Cow milk protein free diet

Mother or infant diet

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 1 Month - 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify 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, rejects the breast or bottle, apnea, back-arching.

You may not qualify 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
• Allergy for cow milk protein
• Infants on Cow's milk free diet

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (3)

Paediatric Department, Hospital of Southern Jutland

Aabenraa, Region Syddanmark, 6200, Denmark

RECRUITING

Børnelægecentret v/Kasper Dalby

Odense, Region Syddanmark, 5000, Denmark

NOT YET RECRUITING

H.C Andersen Childrens' Hospital

Odense, Region Syddanmark, 5000, Denmark

NOT YET RECRUITING

Related Publications (1)

• Barkholt NK, Dalby K, Mogensen CB, Zachariassen G, Gradman J. Infant Reflux Trial: study protocol for a multicentre randomized controlled trial on the treatment of gastroesophageal reflux disease in infants. Trials. 2026 Jan 29. doi: 10.1186/s13063-026-09477-x. Online ahead of print.

  PMID: 41612404 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Infant, Newborn, Diseases

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gitte Zachariassen, Professor

  H.C Andersen Childrens Hospital, Odense University Hospital and Syddansk University (SDU)

  STUDY DIRECTOR

Central Study Contacts

Natalia K Barkholt, MD

CONTACT

+4521787136; Natalia.Barkholt@rsyd.dk

Gitte Zachariassen, Professor

CONTACT

+4565413809; Gitte.Zachariassen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The study is partially blinded. There is blinding in relation to the placebo arm and the proton pump inhibitor arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: October 27, 2025
• Primary Completion (Estimated): December 26, 2026
• Study Completion (Estimated): December 26, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)