Gastrointestinal Tolerance Clinical Trial
Official title:
Growth and Compliance of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula
NCT number | NCT03597113 |
Other study ID # | DA16 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 31, 2018 |
Est. completion date | March 27, 2020 |
Verified date | March 2021 |
Source | Abbott Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 320 |
Est. completion date | March 27, 2020 |
Est. primary completion date | March 27, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 180 Days |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - Participation in another study that has not been approved as a concomitant study by AN |
Country | Name | City | State |
---|---|---|---|
Turkey | Adana City Hospital | Adana | |
Turkey | Afyon Kocatepe University Medical Faculty | Afyon | |
Turkey | Ankara Diskapi Child Disease Hospital A | Ankara | |
Turkey | Ankara Diskapi Child Disease Hospital B | Ankara | |
Turkey | Ankara Dr. Sami Ulus Women and Child Disesase Research and Training Hospital B | Ankara | |
Turkey | Ankara Research and Training Hospital | Ankara | |
Turkey | Ankara University Medical Faculty | Ankara | |
Turkey | Ankara Yildirim Beyazit University Yenimahalle Research and Training Hospital | Ankara | |
Turkey | Gazi Üniversitesi University Medical Faculty | Ankara | |
Turkey | Hacettepe Üniversitesi University Medical Faculty A | Ankara | |
Turkey | Hacettepe Üniversitesi University Medical Faculty B | Ankara | |
Turkey | Akdeniz University Medical Faculty A | Antalya | |
Turkey | Akdeniz University Medical Faculty B | Antalya | |
Turkey | Balikesir University Research and Training Hospital | Balikesir | |
Turkey | TC Saglik Bilimleri University Bursa Yuksek Intisas Research and Training Hospital | Bursa | |
Turkey | Pamukkale University Medical Faculty A | Denizli | |
Turkey | Pamukkale University Medical Faculty B | Denizli | |
Turkey | Firat Üniversitesi University Medical Faculty | Elazig | |
Turkey | Erzurum Research and Training Hospital | Erzurum | |
Turkey | Gaziantep University Medical Faculty | Gaziantep | |
Turkey | Hatay State Hospital | Hatay | |
Turkey | Istanbul Altunizade Acibadem Hospital | Istanbul | |
Turkey | Istanbul Atakent Acibadem Hospital | Istanbul | |
Turkey | Istanbul Bakirköy Dr. Sadi Konuk Research and Training Hospital | Istanbul | |
Turkey | Istanbul Esenler Women and Children Diseases Hospital | Istanbul | |
Turkey | Istanbul Göztepe Research and Training Hospital | Istanbul | |
Turkey | Istanbul Kanuni Sultan Süleyman Research and Training Hospital A | Istanbul | |
Turkey | Istanbul Maslak Acibadem Hospital | Istanbul | |
Turkey | Istanbul Okmeydani Research and Training Hospital | Istanbul | |
Turkey | Istanbul Sisli Hamidiye Etfal Research and Training Hospital A | Istanbul | |
Turkey | Istanbul Sisli Hamidiye Etfal Research and Training Hospital B | Istanbul | |
Turkey | Istanbul Sisli Hamidiye Etfal Research and Training Hospital C | Istanbul | |
Turkey | Istanbul Ümraniye Research and Training Hospital A | Istanbul | |
Turkey | Istanbul Ümraniye Research and Training Hospital B | Istanbul | |
Turkey | Istanbul University Cerrahpasa Medical School | Istanbul | |
Turkey | Istanbul University Istanbul Medical School A | Istanbul | |
Turkey | Kirikkale University Medical Faculty | Kirikkale | |
Turkey | Kocaeli Üniversitesi University Medical Faculty | Kocaeli | |
Turkey | Konya Baskent University Hospital | Konya | |
Turkey | Konya Necmettin Erbakan University Medical Faculty | Konya | |
Turkey | Konya Selçuk University Medical Faculty | Konya | |
Turkey | Inönü Üniversitesi University Medical Faculty | Malatya | |
Turkey | Samsun Research and Training Hospital | Samsun | |
Turkey | Karadeniz Teknik University Medical Faculty | Trabzon | |
Turkey | Trabzon Kanuni Research and Training Hospital | Trabzon | |
Turkey | Zonguldak Bülent Ecevit University Research and Training Hospital | Zonguldak |
Lead Sponsor | Collaborator |
---|---|
Abbott Nutrition |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight | Measured in Kg | Baseline to Study Day 30 | |
Secondary | Formula Intake | Parent completed diary | Baseline to Study Day 30 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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