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NCT03597113 Clinical Trial

Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

Gastrointestinal Tolerance Clinical Trial

Official title:
Growth and Compliance of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date March 2021
Source Abbott Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Abbott Nutrition

Country where clinical trial is conducted

Turkey, 

Outcome
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
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