Gastrointestinal ToleranceNCT03597113
Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula
An observational study of Gastrointestinal Tolerance, run by Abbott Nutrition at 46 sites in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the growth and compliance of an intended use population of infants receiving an extensively hydrolyzed infant formula. Read more about this study
- Who is it for?
- Ages 0 to 180 days
- Conditions the study is for
- Gastrointestinal Tolerance
- How many people
- 320 participants
- Where
- 46 sitesTurkey (Türkiye)
- Study dates
- 31 Jan 2018to 27 Mar 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 0 to 180 days
- All sexes
- No healthy volunteers
- Child
Study population: Subjects will be enrolled from outpatient clinics and physician offices.
Who may be able to join
- Infant is experiencing persistent feeding intolerance or allergy and diagnosed wtih Cow's Milk Protein Allergy (CMPA) or other condition where an extensively hydrolyzed formula is deemed appropriate by their healthcare professional
- Infants using OTC medications, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance
- Parent(s) of infants enrolled on prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids directed by their healthcare professional, confirm their intention to continue their use during the study until directed by their healthcare professional to discontinue.
- Infant is not receiving steroids.
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
- Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study
- Parent(s) confirm their intention not to administer vitamin or mineral supplements to their infant from enrollment through the duration of the study
- Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB)
Who cannot join
- Participation in another study that has not been approved as a concomitant study by AN
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
Turkey (Türkiye)46 sites
Adana City Hospital
Adana, 01150
Afyon Kocatepe University Medical Faculty
Afyonkarahisar, 03200
Ankara Dr. Sami Ulus Women and Child Disesase Research and Training Hospital B
Ankara, 06080
Hacettepe Üniversitesi University Medical Faculty A
Ankara, 06100
Hacettepe Üniversitesi University Medical Faculty B
Ankara, 06100
Ankara Dışkapı Child Disease Hospital A
Ankara, 06110
Ankara Dışkapı Child Disease Hospital B
Ankara, 06110
Ankara Research and Training Hospital
Ankara, 06230
Ankara Yıldırım Beyazıt University Yenimahalle Research and Training Hospital
Ankara, 06370
Gazi Üniversitesi University Medical Faculty
Ankara, 06500
Ankara University Medical Faculty
Ankara, 06590
Akdeniz University Medical Faculty A
Antalya, 07070
Akdeniz University Medical Faculty B
Antalya, 07070
Balıkesir University Research and Training Hospital
Balıkesir, 10145
TC Sağlık Bilimleri University Bursa Yuksek Intisas Research and Training Hospital
Bursa, 16310
Pamukkale University Medical Faculty A
Denizli, 20070
Pamukkale University Medical Faculty B
Denizli, 20070
Fırat Üniversitesi University Medical Faculty
Elâzığ, 23119
Erzurum Research and Training Hospital
Erzurum, 25070
Gaziantep University Medical Faculty
Gaziantep, 27310
Hatay State Hospital
Hatay, 31001
İstanbul University İstanbul Medical School A
Istanbul, 34093
İstanbul University Cerrahpaşa Medical School
Istanbul, 34098
İstanbul Bakırköy Dr. Sadi Konuk Research and Training Hospital
Istanbul, 34147
Istanbul Esenler Women and Children Diseases Hospital
Istanbul, 34230
İstanbul Atakent Acıbadem Hospital
Istanbul, 34303
İstanbul Kanuni Sultan Süleyman Research and Training Hospital A
Istanbul, 34303
İstanbul Sisli Hamidiye Etfal Research and Training Hospital C
Istanbul, 34371
İstanbul Şişli Hamidiye Etfal Research and Training Hospital A
Istanbul, 34371
İstanbul Şişli Hamidiye Etfal Research and Training Hospital B
Istanbul, 34371
İstanbul Okmeydanı Research and Training Hospital
Istanbul, 34384
İstanbul Maslak Acıbadem Hospital
Istanbul, 34457
İstanbul Altunizade Acıbadem Hospital
Istanbul, 34662
İstanbul Göztepe Research and Training Hospital
Istanbul, 34722
İstanbul Ümraniye Research and Training Hospital A
Istanbul, 34764
İstanbul Ümraniye Research and Training Hospital B
Istanbul, 34764
Kırıkkale University Medical Faculty
Kirikkale, 71450
Kocaeli Üniversitesi University Medical Faculty
Kocaeli, 41380
Konya Necmettin Erbakan University Medical Faculty
Konya, 42060
Konya Başkent University Hospital
Konya, 42080
Konya Selçuk University Medical Faculty
Konya, 42130
İnönü Üniversitesi University Medical Faculty
Malatya, 44280
Samsun Research and Training Hospital
Samsun, 55040
Karadeniz Teknik University Medical Faculty
Trabzon, 61080
Trabzon Kanuni Research and Training Hospital
Trabzon, 61290
Zonguldak Bülent Ecevit University Research and Training Hospital
Zonguldak, 67000
About this study
Official title: Growth and Compliance of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula
The purpose of this study is to evaluate the growth and compliance of an intended use population of infants receiving an extensively hydrolyzed infant formula.
- Conditions
- Gastrointestinal Tolerance
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured in Kg
Measured: Baseline to Study Day 30
Secondary outcomes (1)
Formula Intake
Parent completed diary
Measured: Baseline to Study Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start31 Jan 2018
- Primary completion27 Mar 2020
- Study completion27 Mar 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
- 320 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
- NCT03597113
- Sponsor's protocol ID
- DA16
- Status last verified
- Mar 2021
- First submitted
- 13 Jul 2018
- Last updated
- 3 Mar 2021
- 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 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Compliance of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula
- ClinicalTrials.gov ID
- NCT03597113
- Acronym / sponsor ID
- DA16
- Conditions
- Gastrointestinal Tolerance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 27 Mar 2020 (actual)
- Study completion
- 27 Mar 2020 (actual)
- First posted
- 24 Jul 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.
The purpose of this study is to evaluate the growth and compliance of an intended use population of infants receiving an extensively hydrolyzed infant formula.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 180 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Subjects will be enrolled from outpatient clinics and physician offices.
Key inclusion criteria (8 listed)
- Infant is experiencing persistent feeding intolerance or allergy and diagnosed wtih Cow's Milk Protein Allergy (CMPA) or other condition where an extensively hydrolyzed formula is deemed appropriate by their healthcare professional
- Infants using OTC medications, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance
- Parent(s) of infants enrolled on prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids directed by their healthcare professional, confirm their intention to continue their use during the study until directed by their healthcare professional to discontinue.
- Infant is not receiving steroids.
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
Key exclusion criteria (1 listed)
- Participation in another study that has not been approved as a concomitant study by AN
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
Weight
Time frame: Baseline to Study Day 30
Measured in Kg
1 secondary outcome
Formula Intake
Time frame: Baseline to Study Day 30
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 Mar 2021.
- 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.
Aysugul Alptekin, MD study chair
Abbott Turkey
46 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 46 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 8 inclusion and 1 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 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 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?
Weight (time frame: Baseline to Study Day 30). 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 Mar 2021.