Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-06 @ 11:16 AM
Study NCT ID:
NCT06488560
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy (CP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2024-05-07', 'studyFirstSubmitQcDate': '2024-06-27', 'lastUpdatePostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in quality of life as assessed by the Pediatric QoL Inventory of GI Symptom Scale.', 'timeFrame': 'Baseline, end of study (2 months after baseline)', 'description': 'This is a 74 item questionnaire and each is scored from 0 (never) to 4 (almost always), higher score indicating worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Change in fecal samples for microbiome analysis (identity, composition, and relative abundance of bacterial taxa in stool specimens)', 'timeFrame': 'Baseline, end of study (2 months after baseline)'}, {'measure': 'Change in stool metabolomic profile', 'timeFrame': 'Baseline, end of study (2 months after baseline)', 'description': 'Mass spectrometry will be used to assess the following metabolites: amino acids, methylated metabolites, bile acids, and nucleotides.'}, {'measure': 'Change in salivary cytokine profile', 'timeFrame': 'Baseline, end of study (2 months after baseline)', 'description': 'Gene expression of the following salivary inflammatory cytokines will be assessed: interleukin-8 (IL-8), toll-like receptor 8 (TLR8), interleukin-26 (IL-26), interleukin-22 (IL-22), C-C motif chemokine receptor type 1 (CCR1), Caspase 2 (CASP2), toll-like receptor 8 (TLR8), and Intercellular adhesion molecule 3 (ICAM3).'}, {'measure': 'Change in stool caliber using the Bristol stool scale', 'timeFrame': 'Baseline, end of study (2 months after baseline)', 'description': 'The Bristol stool scale categorizes stool into one of 7 types, as follows. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, and 6 and 7 indicate diarrhea.\n\nType 1: Separate hard lumps, like nuts (difficult to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft (average stool) Type 5: Soft blobs with clear cut edges Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea) Type 7: Watery, no solid pieces, entirely liquid (diarrhea)'}, {'measure': 'Number of participants who needed to add or remove antacid or laxative medications from their bowel regimen', 'timeFrame': 'Baseline, end of study (2 months after baseline)', 'description': 'Medications in the bowel regimen include antacids and laxatives.'}, {'measure': 'Number of participants who had dose adjustments to their antacid or laxative medications', 'timeFrame': 'Baseline, end of study (2 months after baseline)'}, {'measure': 'Change in weight', 'timeFrame': 'Baseline, end of study (2 months after baseline)'}, {'measure': 'Change in weight percentile', 'timeFrame': 'Baseline, end of study (2 months after baseline)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blenderized tube feeds (BTF)', 'commercial blenderized tube feed (CBTF)', 'Commercial formula'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scale Gastrointestinal Symptoms Scale (GI-PedsQL) differences , to assess the differences in stool microbiome and stool metabolomics , to assess differences in salivary cytokine profile , to assess differences in weight change , to compare the use of antacid medications and to compare the use of laxative medications in patients on commercial formulas (CF) versus commercial blenderized tube feed (CBTF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with CP receiving \\>75% of total daily caloric requirements from commercial formulas (CF) via a gastrostomy tube 12french or greater\n* Patients' insurance covers a CBTF\n* Diagnosis of cerebral palsy\n\nExclusion Criteria:\n\n* Receiving enteral nutrition by transpyloric feeds or jejunal tube.\n* Receiving \\<75% of total daily energy requirements from a commercial formula\n* Weight or weight for length or body mass index less than the 5th percentile for age or greater than the 85th% percentile for age when plotted on the cerebral palsy growth chart\n* Rapidly progressive neurodegenerative disease diagnosis\n* Use of monomeric formulas"}, 'identificationModule': {'nctId': 'NCT06488560', 'briefTitle': 'The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy (CP)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy: A Single Center Randomized Open Label Clinical Trial', 'orgStudyIdInfo': {'id': 'HSC-MS-24-0047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'commercial blenderized tube feed (CBTF)', 'interventionNames': ['Dietary Supplement: commercial blenderized tube feed (CBTF)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'commercial formulas (CF)', 'interventionNames': ['Dietary Supplement: commercial formulas (CF)']}], 'interventions': [{'name': 'commercial blenderized tube feed (CBTF)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Based on assessment by a dietician the participant will be fed the commercial blenderized formula to meet their caloric needs', 'armGroupLabels': ['commercial blenderized tube feed (CBTF)']}, {'name': 'commercial formulas (CF)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participant will be fed the commercial formula to meet their caloric needs per standard of care', 'armGroupLabels': ['commercial formulas (CF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Fernando Navarro, MD', 'role': 'CONTACT', 'email': 'Fernando.Navarro@uth.tmc.edu', 'phone': '713-500-5663'}, {'name': 'Ana F Alvarez', 'role': 'CONTACT', 'email': 'Ana.B.FadhelAlvarez@uth.tmc.edu', 'phone': '(713) 500-5663'}], 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Fernando Navarro, MD', 'role': 'CONTACT', 'email': 'Fernando.Navarro@uth.tmc.edu', 'phone': '(713) 500-5663'}, {'name': 'Ana F Alvarez', 'role': 'CONTACT', 'email': 'Ana.B.FadhelAlvarez@uth.tmc.edu', 'phone': '(713) 500-5663'}], 'overallOfficials': [{'name': 'Fernando Navarro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Fernando Navarro', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}