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Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

NCT ID: NCT03597113

Last Updated: 2021-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-31

Study Completion Date

2020-03-27

Brief Summary

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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.

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Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula

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Detailed Description

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Conditions

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Gastrointestinal Tolerance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

0 Days

Maximum Eligible Age

180 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Nutrition

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aysugul Alptekin, MD

Role: STUDY_CHAIR

Abbott Turkey

Locations

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Adana City Hospital

Adana, , Turkey (Türkiye)

Site Status

Afyon Kocatepe University Medical Faculty

Afyonkarahisar, , Turkey (Türkiye)

Site Status

Ankara Dr. Sami Ulus Women and Child Disesase Research and Training Hospital B

Ankara, , Turkey (Türkiye)

Site Status

Hacettepe Üniversitesi University Medical Faculty A

Ankara, , Turkey (Türkiye)

Site Status

Hacettepe Üniversitesi University Medical Faculty B

Ankara, , Turkey (Türkiye)

Site Status

Ankara Dışkapı Child Disease Hospital A

Ankara, , Turkey (Türkiye)

Site Status

Ankara Dışkapı Child Disease Hospital B

Ankara, , Turkey (Türkiye)

Site Status

Ankara Research and Training Hospital

Ankara, , Turkey (Türkiye)

Site Status

Ankara Yıldırım Beyazıt University Yenimahalle Research and Training Hospital

Ankara, , Turkey (Türkiye)

Site Status

Gazi Üniversitesi University Medical Faculty

Ankara, , Turkey (Türkiye)

Site Status

Ankara University Medical Faculty

Ankara, , Turkey (Türkiye)

Site Status

Akdeniz University Medical Faculty A

Antalya, , Turkey (Türkiye)

Site Status

Akdeniz University Medical Faculty B

Antalya, , Turkey (Türkiye)

Site Status

Balıkesir University Research and Training Hospital

Balıkesir, , Turkey (Türkiye)

Site Status

TC Sağlık Bilimleri University Bursa Yuksek Intisas Research and Training Hospital

Bursa, , Turkey (Türkiye)

Site Status

Pamukkale University Medical Faculty A

Denizli, , Turkey (Türkiye)

Site Status

Pamukkale University Medical Faculty B

Denizli, , Turkey (Türkiye)

Site Status

Fırat Üniversitesi University Medical Faculty

Elâzığ, , Turkey (Türkiye)

Site Status

Erzurum Research and Training Hospital

Erzurum, , Turkey (Türkiye)

Site Status

Gaziantep University Medical Faculty

Gaziantep, , Turkey (Türkiye)

Site Status

Hatay State Hospital

Hatay, , Turkey (Türkiye)

Site Status

İstanbul University İstanbul Medical School A

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul University Cerrahpaşa Medical School

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Bakırköy Dr. Sadi Konuk Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Istanbul Esenler Women and Children Diseases Hospital

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Atakent Acıbadem Hospital

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Kanuni Sultan Süleyman Research and Training Hospital A

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Sisli Hamidiye Etfal Research and Training Hospital C

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Şişli Hamidiye Etfal Research and Training Hospital A

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Şişli Hamidiye Etfal Research and Training Hospital B

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Okmeydanı Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Maslak Acıbadem Hospital

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Altunizade Acıbadem Hospital

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Göztepe Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Ümraniye Research and Training Hospital A

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Ümraniye Research and Training Hospital B

Istanbul, , Turkey (Türkiye)

Site Status

Kocaeli Üniversitesi University Medical Faculty

Kocaeli, , Turkey (Türkiye)

Site Status

Konya Necmettin Erbakan University Medical Faculty

Konya, , Turkey (Türkiye)

Site Status

Konya Başkent University Hospital

Konya, , Turkey (Türkiye)

Site Status

Konya Selçuk University Medical Faculty

Konya, , Turkey (Türkiye)

Site Status

Kırıkkale University Medical Faculty

Kırıkkale, , Turkey (Türkiye)

Site Status

İnönü Üniversitesi University Medical Faculty

Malatya, , Turkey (Türkiye)

Site Status

Samsun Research and Training Hospital

Samsun, , Turkey (Türkiye)

Site Status

Karadeniz Teknik University Medical Faculty

Trabzon, , Turkey (Türkiye)

Site Status

Trabzon Kanuni Research and Training Hospital

Trabzon, , Turkey (Türkiye)

Site Status

Zonguldak Bülent Ecevit University Research and Training Hospital

Zonguldak, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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DA16

Identifier Type: -

Identifier Source: org_study_id

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