Gastrointestinal Dysmotility on Aspiration Risk

Gastro Esophageal Reflux Clinical Trial

Official title:

The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05455359
• Other study ID #: IRB-P00038381
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 18, 2022
• Est. completion date: July 18, 2027

Study information

• Verified date: July 2022
• Source: Boston Children's Hospital
• Contact: Rachel Rosen, MD
• Phone: 617-355-0897
• Email: rachel.rosen[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The hypothesis of this study is that esophageal and gastric dysmotility increase the risk of developing aspiration-associated symptoms in children with neurologic impairment. The investigators are conducting a ten week cross over study comparing prucalopride to famotidine for the treatment of aspiration-associated symptoms.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: July 18, 2027
• Est. primary completion date: July 18, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 21 Years

Eligibility

Inclusion Criteria:

1. are 5-21 years of age;

2. receive >90% of their calories by enteral tube (i.e., patients take no food or drink by mouth);

3. are determined to be at high risk for aspiration pneumonia based on evidence of impaired airway protective mechanisms, documented by aspiration on video fluoroscopic swallow study;

4. have static neurologic impairment, defined as functional and/or intellectual impairment that results from a chronic neurologic or related diagnosis (e.g., cerebral palsy) with no prospect of progression for at least one year;

5. have chronic respiratory symptoms, defined as coughing, choking, or need for oral suctioning a minimum of three times per week during the prior four weeks. -

Exclusion Criteria:

1. have progressive neurologic impairment;

2. have a history of prior intact Nissen fundoplication;

3. are currently taking oral or inhaled antibiotics, including prophylactic antibiotics;

4. are currently taking or have taken in the last four weeks acid suppression (H2 antagonist or PPI); or

5. are fed by gastrojejunostomy rather than by gastrostomy. -

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Esophageal Motility Disorders
• Esophageal Spasm, Diffuse
• Gastric Motor Dysfunction
• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• Pneumonia, Aspiration

Intervention

Drug:
• Prucalopride
Prucalopride 0.04 mg/kg/day
• Famotidine
Famotidine 0.4 mg/kg/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Cough Quality of Life Questionnaire	Comparison of the mean difference in the Pediatric Cough Quality of Life Questionnaire (range: 7 to 189, lower scores=more symptom impairment) between baseline and 4 week scores between Arm 1 and Arm 2	4 weeks
Secondary	Gastric emptying outcomes	Comparison of within-patient differences in gastric residuals by nuclear scintigraphy	4 weeks
Secondary	Total Peds-GI QL score	Comparison of the mean difference in total Peds-GI QL scores (range: 0-100, lower=worse symptoms) between famotidine and prucalopride periods	8 weeks
Secondary	Aspiration symptoms	Comparison of the mean difference in the number of coughing or choking episodes per week during the fourth week of treatment	4 weeks
Secondary	Microbiome	Comparison of within-patient differences in microbiome diversity and abundance between baseline and after each medication period	8 weeks
Secondary	Pneumonias	Comparisons in the number of aspiration pneumonias between each treatment period	10 weeks
Secondary	Esophageal reflux events	Comparison of within-patient differences in post-prandial reflux events by nuclear scintigraphy	4 weeks