TolerUp Enteral Feeding Protocol
A Prospective, Observational Study to Evaluate Gastrointestinal Symptoms and Safety of an Enteral Feeding Product in Pediatric Patients With Cerebral Palsy
1 other identifier
observational
133
1 country
19
Brief Summary
This prospective, observational, multi-center study will follow children with cerebral palsy who decided to switch to an enteral product that contains partially hydrolyzed protein and medium chain triglycerides as a result of clinical symptoms/diagnosis of gastrointestinal intolerance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2018
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 19, 2018
CompletedFirst Submitted
Initial submission to the registry
July 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2020
CompletedNovember 3, 2020
November 1, 2020
2.4 years
July 13, 2018
November 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Gastro-Intestinal Tolerance
healthcare professional assessed
Baseline to 6 months
Secondary Outcomes (2)
Anthropometrics
Baseline to 6 months
Care Giver Satisfaction of Enteral Product
Baseline to 6 months
Eligibility Criteria
Study population will be composed of patients aged 1-12 and under follow-up in participating study centers in Turkey.
You may qualify if:
- Diagnosis of cerebral palsy
- Fed with an enteral product that does not contain partially hydrolyzed protein and medium chain triglycerides and decided to be switched to an enteral product contains partially hydrolyzed protein and medium chain triglycerides as a result of clinical symptoms/diagnosis of gastrointestinal intolerance
- Fed by tube, using enteral tube feeding as sole source of nutrition
- A signed and dated informed consent by subject's legally acceptable representative
You may not qualify if:
- Chronic diseases other than cerebral palsy (e.g. diabetes mellitus, renal, liver, endocrine diseases, malignancy)
- Intestinal obstruction
- Dialysis treatment
- Requirement of artificial ventilation
- Requirement of parenteral nutrition
- Normal nutrition in addition to enteral tube feeding
- Allergy or intolerance to any ingredient of the study product
- Currently participating in another clinical or non-clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (19)
Çukurova University Medical Faculty
Adana, 01330, Turkey (Türkiye)
Hacettepe Üniversitesi University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Ankara Dışkapı Child Disease Hospital
Ankara, 06110, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, 06500, Turkey (Türkiye)
Ankara University Medical Faculty
Ankara, 06590, Turkey (Türkiye)
Bursa Yüksek İhtisas Research and Training Hospital
Bursa, 16310, Turkey (Türkiye)
Pamukkale Üniversitesi University Medical Faculty
Denizli, 20070, Turkey (Türkiye)
Elazığ University Medical Faculty
Elâzığ, 23119, Turkey (Türkiye)
Eskişehir Osmangazi University Medical Faculty
Eskişehir, 26480, Turkey (Türkiye)
Koç University Medical Faculty
Istanbul, 34010, Turkey (Türkiye)
İstanbul Kanuni Sultan Süleyman Research and Training Hospital
Istanbul, 34303, Turkey (Türkiye)
İstanbul Şişli Hamidiye Etfal Research and Training Hospital
Istanbul, 34371, Turkey (Türkiye)
İstanbul Ümraniye Research and Training Hospital
Istanbul, 34764, Turkey (Türkiye)
İzmir Behçet Uz Child Disease Hospital
Izmir, 35210, Turkey (Türkiye)
Kocaeli Üniversitesi University Medical Faculty
Kocaeli, 41380, Turkey (Türkiye)
Kırıkkale University Medical Faculty
Kırıkkale, 71450, Turkey (Türkiye)
İnönü Üniversitesi University Medical Faculty
Malatya, 44280, Turkey (Türkiye)
Ondokuz Mayıs University Medical Faculty
Samsun, 55280, Turkey (Türkiye)
Karadeniz Teknik University Medical Faculty
Trabzon, 61080, Turkey (Türkiye)
Study Officials
- STUDY CHAIR
Aysugül Alptekin, MD
Abbott Turkey
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2018
First Posted
August 27, 2018
Study Start
February 19, 2018
Primary Completion
July 20, 2020
Study Completion
July 20, 2020
Last Updated
November 3, 2020
Record last verified: 2020-11