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NCT03648255 Clinical Trial

TolerUp Enteral Feeding Protocol

Gastrointestinal Tolerance Clinical Trial

Official title:
A Prospective, Observational Study to Evaluate Gastrointestinal Symptoms and Safety of an Enteral Feeding Product in Pediatric Patients With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03648255
Other study ID # DA15
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 19, 2018
Est. completion date July 20, 2020

Study information
Verified date November 2020
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 133
Est. completion date July 20, 2020
Est. primary completion date July 20, 2020
Accepts healthy volunteers No
Gender All
Age group 1 Year to 12 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Turkey Çukurova University Medical Faculty Adana
Turkey Ankara Diskapi Child Disease Hospital Ankara
Turkey Ankara University Medical Faculty Ankara
Turkey Gazi University Medical Faculty Ankara
Turkey Hacettepe Üniversitesi University Medical Faculty Ankara
Turkey Bursa Yüksek Ihtisas Research and Training Hospital Bursa
Turkey Pamukkale Üniversitesi University Medical Faculty Denizli
Turkey Elazig University Medical Faculty Elazig
Turkey Eskisehir Osmangazi University Medical Faculty Eskisehir
Turkey Istanbul Kanuni Sultan Süleyman Research and Training Hospital Istanbul
Turkey Istanbul Sisli Hamidiye Etfal Research and Training Hospital Istanbul
Turkey Istanbul Ümraniye Research and Training Hospital Istanbul
Turkey Koç University Medical Faculty Istanbul
Turkey Izmir Behçet Uz Child Disease Hospital Izmir
Turkey Kirikkale University Medical Faculty Kirikkale
Turkey Kocaeli Üniversitesi University Medical Faculty Kocaeli
Turkey Inönü Üniversitesi University Medical Faculty Malatya
Turkey Ondokuz Mayis University Medical Faculty Samsun
Turkey Karadeniz Teknik University Medical Faculty Trabzon

Sponsors (1)
Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Gastro-Intestinal Tolerance healthcare professional assessed Baseline to 6 months
Secondary Anthropometrics change in weight from baseline measurement Baseline to 6 months
Secondary Care Giver Satisfaction of Enteral Product survey administered by healthcare professional Baseline to 6 months
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