GERD in Children With Cystic Fibrosis | NCT06617013 | Trialant

GERD in Children With Cystic Fibrosis | NCT06617013 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Child with cystic fibrosis (CF) on GERD therapy without severe GERD	Experimental	The GSAS will be completed at baseline, GERD therapy will be discontinued, and GSAS will be repeated 12 weeks later.	Other: Discontinuation of GERD therapy
Child with cystic fibrosis (CF)	No Intervention	The GSAS will be completed at baseline.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Discontinuation of GERD therapy	Other	GERD therapy will be discontinued at time of enrollment.	Child with cystic fibrosis (CF) on GERD therapy without severe GERD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in the mean GSAS score (only if GERD medication discontinued)	The Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) is a 15-item tool validated in children in assessing gastroesophageal reflux disease-related symptoms. The GSAS ranges from 0 to 490, with a higher score representing worse GERD symptoms, and a score ≥ 15 reflects significant GERD symptoms.	baseline and 12 weeks
Mean GSAS score in children with CF on GERD therapy	GSAS ranges from 0 to 490, with a higher score representing worse GERD symptoms, and a score ≥ 15 reflects significant GERD symptoms. A value of 80 will be used as a maximum cut-off for mild symptoms as this was 2 SD from the mean GSAS for children without baseline GERD.	Baseline
Mean GSAS score in children with CF not on GERD therapy	GSAS ranges from 0 to 490, with a higher score representing worse GERD symptoms, and a score ≥ 15 reflects significant GERD symptoms. A value of 80 will be used as a maximum cut-off for mild symptoms as this was 2 SD from the mean GSAS for children without baseline GERD.	Baseline

Contacts/Locations Module