Gastrointestinal ToleranceNCT03648255
TolerUp Enteral Feeding Protocol
An observational study of Gastrointestinal Tolerance, run by Abbott Nutrition at 19 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Gastrointestinal Tolerance
- How many people
- 133 participants
- Where
- 19 sitesTurkey (Türkiye)
- Study dates
- 19 Feb 2018to 20 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Study population will be composed of patients aged 1-12 and under follow-up in participating study centers in Turkey.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Turkey (Türkiye)19 sites
Çukurova University Medical Faculty
Adana, 01330
Hacettepe Üniversitesi University Medical Faculty
Ankara, 06100
Ankara Dışkapı Child Disease Hospital
Ankara, 06110
Gazi University Medical Faculty
Ankara, 06500
Ankara University Medical Faculty
Ankara, 06590
Bursa Yüksek İhtisas Research and Training Hospital
Bursa, 16310
Pamukkale Üniversitesi University Medical Faculty
Denizli, 20070
Elazığ University Medical Faculty
Elâzığ, 23119
Eskişehir Osmangazi University Medical Faculty
Eskişehir, 26480
Koç University Medical Faculty
Istanbul, 34010
İstanbul Kanuni Sultan Süleyman Research and Training Hospital
Istanbul, 34303
İstanbul Şişli Hamidiye Etfal Research and Training Hospital
Istanbul, 34371
İstanbul Ümraniye Research and Training Hospital
Istanbul, 34764
İzmir Behçet Uz Child Disease Hospital
Izmir, 35210
Kırıkkale University Medical Faculty
Kirikkale, 71450
Kocaeli Üniversitesi University Medical Faculty
Kocaeli, 41380
İnönü Üniversitesi University Medical Faculty
Malatya, 44280
Ondokuz Mayıs University Medical Faculty
Samsun, 55280
Karadeniz Teknik University Medical Faculty
Trabzon, 61080
About this study
Official title: A Prospective, Observational Study to Evaluate Gastrointestinal Symptoms and Safety of an Enteral Feeding Product in Pediatric Patients With Cerebral Palsy
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.
- Conditions
- Gastrointestinal Tolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastro-Intestinal Tolerance
healthcare professional assessed
Measured: Baseline to 6 months
Secondary outcomes (2)
Anthropometrics
change in weight from baseline measurement
Measured: Baseline to 6 months
Care Giver Satisfaction of Enteral Product
survey administered by healthcare professional
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start19 Feb 2018
- Primary completion20 Jul 2020
- Study completion20 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aysugül Alptekin, MD, Study chair, Abbott Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648255
- Sponsor's protocol ID
- DA15
- Status last verified
- Nov 2020
- First submitted
- 13 Jul 2018
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study to Evaluate Gastrointestinal Symptoms and Safety of an Enteral Feeding Product in Pediatric Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03648255
- Acronym / sponsor ID
- DA15
- Conditions
- Gastrointestinal Tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study population will be composed of patients aged 1-12 and under follow-up in participating study centers in Turkey.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gastro-Intestinal Tolerance
Time frame: Baseline to 6 months
healthcare professional assessed
2 secondary outcomes
Anthropometrics
Time frame: Baseline to 6 months
Care Giver Satisfaction of Enteral Product
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aysugül Alptekin, MD study chair
Abbott Turkey
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Tolerance, run by Abbott Nutrition at 19 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastro-Intestinal Tolerance (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.