Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-02-22 @ 4:38 AM
Study NCT ID:
NCT05455359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-07-13
First Post:
2022-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastrointestinal Dysmotility on Aspiration Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D011015', 'term': 'Pneumonia, Aspiration'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C406662', 'term': 'prucalopride'}, {'id': 'D015738', 'term': 'Famotidine'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-07-18', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2027-07-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-08', 'studyFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2022-07-08', 'lastUpdatePostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-07-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pediatric Cough Quality of Life Questionnaire', 'timeFrame': '4 weeks', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Gastric emptying outcomes', 'timeFrame': '4 weeks', 'description': 'Comparison of within-patient differences in gastric residuals by nuclear scintigraphy'}, {'measure': 'Total Peds-GI QL score', 'timeFrame': '8 weeks', 'description': 'Comparison of the mean difference in total Peds-GI QL scores (range: 0-100, lower=worse symptoms) between famotidine and prucalopride periods'}, {'measure': 'Aspiration symptoms', 'timeFrame': '4 weeks', 'description': 'Comparison of the mean difference in the number of coughing or choking episodes per week during the fourth week of treatment'}, {'measure': 'Microbiome', 'timeFrame': '8 weeks', 'description': 'Comparison of within-patient differences in microbiome diversity and abundance between baseline and after each medication period'}, {'measure': 'Pneumonias', 'timeFrame': '10 weeks', 'description': 'Comparisons in the number of aspiration pneumonias between each treatment period'}, {'measure': 'Esophageal reflux events', 'timeFrame': '4 weeks', 'description': 'Comparison of within-patient differences in post-prandial reflux events by nuclear scintigraphy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Motility Disorders', 'Gastric Motor Dysfunction', 'Aspiration Pneumonia', 'Gastro Esophageal Reflux']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. are 5-21 years of age;\n2. receive \\>90% of their calories by enteral tube (i.e., patients take no food or drink by mouth);\n3. 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;\n4. 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;\n5. 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.\n\n \\-\n\nExclusion Criteria:\n\n1. have progressive neurologic impairment;\n2. have a history of prior intact Nissen fundoplication;\n3. are currently taking oral or inhaled antibiotics, including prophylactic antibiotics;\n4. are currently taking or have taken in the last four weeks acid suppression (H2 antagonist or PPI); or\n5. are fed by gastrojejunostomy rather than by gastrostomy. -'}, 'identificationModule': {'nctId': 'NCT05455359', 'briefTitle': 'Gastrointestinal Dysmotility on Aspiration Risk', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'The Impact of Upper Gastrointestinal Dysmotility on Aspiration-associated Symptoms', 'orgStudyIdInfo': {'id': 'IRB-P00038381'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Patients will be undergo 1 week observation period followed by 4 weeks of prucalopride followed by 1 weeks of a wash out followed by 4 weeks of famotidine', 'interventionNames': ['Drug: Prucalopride', 'Drug: Famotidine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Patients will be undergo 1 week observation period followed by 4 weeks of famotidine followed by 1 weeks of a wash out followed by 4 weeks of prucalopride', 'interventionNames': ['Drug: Prucalopride', 'Drug: Famotidine']}], 'interventions': [{'name': 'Prucalopride', 'type': 'DRUG', 'description': 'Prucalopride 0.04 mg/kg/day', 'armGroupLabels': ['Arm 1', 'Arm 2']}, {'name': 'Famotidine', 'type': 'DRUG', 'description': 'Famotidine 0.4 mg/kg/day', 'armGroupLabels': ['Arm 1', 'Arm 2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rachel Rosen, MD', 'role': 'CONTACT', 'email': 'rachel.rosen@childrens.harvard.edu', 'phone': '617-355-0897'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Rachel Rosen', 'investigatorAffiliation': "Boston Children's Hospital"}}}}