GI ToleranceNCT02819401
The Effects of a High-fiber Formula in Children With Failure to Thrive
An observational study of GI Tolerance, run by Abbott Nutrition at 17 sites in Turkey (Türkiye).
Trial summary
The present study is designed to determine the gastrointestinal tolerability of enteral nutritional products, physicians and parents' overall perception of enteral nutrition products as well as providing basic demographic information on pediatric populations prescribed these formula for supportive treatment as part of… Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- GI Tolerance
- What is being tested?
- pediatric formula
- How many people
- 345 participants
- Where
- 17 sitesTurkey (Türkiye)
- Study dates
- Feb 2013to Jun 2015
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children diagnosed with failure to thrive who are receiving a high-fiber enteral formula for supportive treatment as part of the routine healthcare service in Turkey.
Who may be able to join
- Age; 1-10 years (inclusive)
- Children diagnosed as failure-to-thrive(FTT).
- Children who have been recently prescribed and treatment initiated with isocaloric or hypercaloric high-fiber pediatric enteral formula suitable for oral and/or nasogastric tube feeding before inclusion in the study.
Who cannot join
- Chronic renal disorder
- Decompensated liver disease
- Any other chronic condition that was not under control (e.g. diabetes, thyroid disorder, etc.)
- Any type of malignant disease including leukemia and lymphoma
- Cystic fibrosis
- Short bowel syndrome
Show all 9Show fewer
- Any type of food allergy or intolerance
- Growth hormone deficiency
- Use of enteral feeding within the last 4 weeks
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Turkey (Türkiye)17 sites
Ankara Üniversitesi Tıp Fakültesi
Ankara, 06100
Trakya Üniversitesi Tıp Fakültesi
Edirne, 22030
Fırat Üniversitesi Tıp Fakültesi
Elâzığ, 23200
Özel Doğu Anadolu Hastanesi
Elâzığ
Gaziantep Üniversitesi Tıp Fakültesi
Gaziantep, 27070
Memorial Şişli Hastanesi
Istanbul, 34385
Medeniyet Üniversitesi Göztepe Eğitim ve Araştırma Hastanesi
Istanbul, 34722
Dr.Sadi Konuk Eğitim ve Araştırma Hastan
Istanbul
Şifa Üniversitesi Bornova Sağlık Uygulama ve Araştırma Merkezi
Izmir, 35100
Behçet Uz Çocuk Hastalıkları Hastanesi
Izmir
İzmir Tepecik Eğitim ve Araştırma Hastanes
Izmir
Erciyes Üniversitesi Tıp Fakültesi
Kayseri̇, 38039
Kırıkkale Üniversitesi Tıp Fakültesi
Kirikkale
Kocaeli Üniversitesi Tıp Fakültesi
Kocaeli
Konya Üniversitesi Selçuk Tıp Fakültesi
Konya, 42250
Samsun Kadın Doğum ve Çocuk Hastanesi
Samsun, 55070
Ondokuz Mayıs Üniversitesi Tıp Fakültesi
Samsun, 55139
About this study
Official title: A Prospective, Open-label, Post-marketing Observational Study to Evaluate the Effects of High-fiber Enteral Pediatric Formula in Children With Failure to Thrive Due to Malnutrition
The present study is designed to determine the gastrointestinal tolerability of enteral nutritional products, physicians and parents' overall perception of enteral nutrition products as well as providing basic demographic information on pediatric populations prescribed these formula for supportive treatment as part of the routine healthcare service in Turkey.
- Conditions
- GI Tolerance
- Being tested
- pediatric formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pediatric formulaOther
high-fiber enteral formula
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician Perception of Formula Use
Questionnaire
Measured: Baseline to Month 6
Secondary outcomes (3)
Gastrointestinal Tolerance
Subject questionnaires
Measured: Baseline to Month 1, Month 2, Month 4 and Month 6
Description of Population
Demographic collection of patients recommended high-fiber enteral formula
Measured: Baseline
Weight
Measured: Baseline to Month 1, Month 2, Month 4 and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startFeb 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI 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
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aysugul Alptekin, MD, Study chair, Abbott Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819401
- Sponsor's protocol ID
- ANTK1001
- Status last verified
- Jun 2016
- First submitted
- 18 Mar 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Post-marketing Observational Study to Evaluate the Effects of High-fiber Enteral Pediatric Formula in Children With Failure to Thrive Due to Malnutrition
- ClinicalTrials.gov ID
- NCT02819401
- Acronym / sponsor ID
- ANTK1001
- Conditions
- GI Tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Jun 2016 (estimated)
- 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.
The present study is designed to determine the gastrointestinal tolerability of enteral nutritional products, physicians and parents' overall perception of enteral nutrition products as well as providing basic demographic information on pediatric populations prescribed these formula for supportive treatment as part of the routine healthcare service in Turkey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children diagnosed with failure to thrive who are receiving a high-fiber enteral formula for supportive treatment as part of the routine healthcare service in Turkey.
Key inclusion criteria (3 listed)
- Age; 1-10 years (inclusive)
- Children diagnosed as failure-to-thrive(FTT).
- Children who have been recently prescribed and treatment initiated with isocaloric or hypercaloric high-fiber pediatric enteral formula suitable for oral and/or nasogastric tube feeding before inclusion in the study.
Key exclusion criteria (9 listed)
- Chronic renal disorder
- Decompensated liver disease
- Any other chronic condition that was not under control (e.g. diabetes, thyroid disorder, etc.)
- Any type of malignant disease including leukemia and lymphoma
- Cystic fibrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pediatric formulahigh-fiber enteral formula | Other | – |
Primary outcome
Physician Perception of Formula Use
Time frame: Baseline to Month 6
Questionnaire
3 secondary outcomes
Gastrointestinal Tolerance
Time frame: Baseline to Month 1, Month 2, Month 4 and Month 6
Description of Population
Time frame: Baseline
Weight
Time frame: Baseline to Month 1, Month 2, Month 4 and Month 6
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 30 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for GI Tolerance
Not yet recruiting
A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
Postprandial Glucose, GI Tolerance
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.
Aysugul Alptekin, MD study chair
Abbott Turkey
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GI Tolerance, run by Abbott Nutrition at 17 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 3 inclusion and 9 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 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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?
Physician Perception of Formula Use (time frame: Baseline to Month 6). 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 30 Jun 2016.