NCT06255886 Treatment of Gastroesophageal Reflux Disease in Infants
| NCT ID | NCT06255886 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Odense University Hospital |
| Condition | Gastroesophageal Reflux |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2026-12-26 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 96 participants in total. It began in 2025-10-27 with a primary completion date of 2026-12-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
Inclusion 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. Exclusion Criteria: * 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
Contact & Investigator
Gitte Zachariassen, Professor
STUDY DIRECTOR
H.C Andersen Childrens Hospital, Odense University Hospital and Syddansk University (SDU)
Frequently Asked Questions
Who can join the NCT06255886 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 1 Year, studying Gastroesophageal Reflux. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06255886 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06255886 currently recruiting?
Yes, NCT06255886 is actively recruiting participants. Contact the research team at Natalia.Barkholt@rsyd.dk for enrollment information.
Where is the NCT06255886 trial being conducted?
This trial is being conducted at Aabenraa, Denmark, Odense, Denmark, Odense, Denmark.
Who is sponsoring the NCT06255886 clinical trial?
NCT06255886 is sponsored by Odense University Hospital. The principal investigator is Gitte Zachariassen, Professor at H.C Andersen Childrens Hospital, Odense University Hospital and Syddansk University (SDU). The trial plans to enroll 96 participants.