- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03597113
Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula
March 2, 2021 updated by: Abbott Nutrition
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
320
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Adana, Turkey, 01150
- Adana City Hospital
-
Afyon, Turkey, 03200
- Afyon Kocatepe University Medical Faculty
-
Ankara, Turkey, 06590
- Ankara University Medical Faculty
-
Ankara, Turkey, 06080
- Ankara Dr. Sami Ulus Women and Child Disesase Research and Training Hospital B
-
Ankara, Turkey, 06100
- Hacettepe Üniversitesi University Medical Faculty A
-
Ankara, Turkey, 06100
- Hacettepe Üniversitesi University Medical Faculty B
-
Ankara, Turkey, 06110
- Ankara Dışkapı Child Disease Hospital A
-
Ankara, Turkey, 06110
- Ankara Dışkapı Child Disease Hospital B
-
Ankara, Turkey, 06230
- Ankara Research and Training Hospital
-
Ankara, Turkey, 06370
- Ankara Yıldırım Beyazıt University Yenimahalle Research and Training Hospital
-
Ankara, Turkey, 06500
- Gazi Üniversitesi University Medical Faculty
-
Antalya, Turkey, 07070
- Akdeniz University Medical Faculty A
-
Antalya, Turkey, 07070
- Akdeniz University Medical Faculty B
-
Balıkesir, Turkey, 10145
- Balıkesir University Research and Training Hospital
-
Bursa, Turkey, 16310
- TC Sağlık Bilimleri University Bursa Yuksek Intisas Research and Training Hospital
-
Denizli, Turkey, 20070
- Pamukkale University Medical Faculty A
-
Denizli, Turkey, 20070
- Pamukkale University Medical Faculty B
-
Elazığ, Turkey, 23119
- Fırat Üniversitesi University Medical Faculty
-
Erzurum, Turkey, 25070
- Erzurum Research and Training Hospital
-
Gaziantep, Turkey, 27310
- Gaziantep University Medical Faculty
-
Hatay, Turkey, 31001
- Hatay State Hospital
-
Istanbul, Turkey, 34230
- Istanbul Esenler Women and Children Diseases Hospital
-
Kocaeli, Turkey, 41380
- Kocaeli Üniversitesi University Medical Faculty
-
Konya, Turkey, 42060
- Konya Necmettin Erbakan University Medical Faculty
-
Konya, Turkey, 42080
- Konya Başkent University Hospital
-
Konya, Turkey, 42130
- Konya Selcuk University Medical Faculty
-
Kırıkkale, Turkey, 71450
- Kırıkkale University Medical Faculty
-
Malatya, Turkey, 44280
- İnönü Üniversitesi University Medical Faculty
-
Samsun, Turkey, 55040
- Samsun Research and Training Hospital
-
Trabzon, Turkey, 61080
- Karadeniz Teknik University Medical Faculty
-
Trabzon, Turkey, 61290
- Trabzon Kanuni Research and Training Hospital
-
Zonguldak, Turkey, 67000
- Zonguldak Bülent Ecevit University Research and Training Hospital
-
İstanbul, Turkey, 34093
- İstanbul University İstanbul Medical School A
-
İstanbul, Turkey, 34098
- İstanbul University Cerrahpaşa Medical School
-
İstanbul, Turkey, 34147
- İstanbul Bakırköy Dr. Sadi Konuk Research and Training Hospital
-
İstanbul, Turkey, 34303
- İstanbul Atakent Acıbadem Hospital
-
İstanbul, Turkey, 34303
- İstanbul Kanuni Sultan Süleyman Research and Training Hospital A
-
İstanbul, Turkey, 34371
- İstanbul Sisli Hamidiye Etfal Research and Training Hospital C
-
İstanbul, Turkey, 34371
- İstanbul Şişli Hamidiye Etfal Research and Training Hospital A
-
İstanbul, Turkey, 34371
- İstanbul Şişli Hamidiye Etfal Research and Training Hospital B
-
İstanbul, Turkey, 34384
- İstanbul Okmeydanı Research and Training Hospital
-
İstanbul, Turkey, 34457
- İstanbul Maslak Acıbadem Hospital
-
İstanbul, Turkey, 34662
- İstanbul Altunizade Acıbadem Hospital
-
İstanbul, Turkey, 34722
- İstanbul Göztepe Research and Training Hospital
-
İstanbul, Turkey, 34764
- İstanbul Ümraniye Research and Training Hospital A
-
İstanbul, Turkey, 34764
- İstanbul Ümraniye Research and Training Hospital B
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second to 5 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects will be enrolled from outpatient clinics and physician offices.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: Baseline to Study Day 30
|
Measured in Kg
|
Baseline to Study Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Formula Intake
Time Frame: Baseline to Study Day 30
|
Parent completed diary
|
Baseline to Study Day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Aysugul Alptekin, MD, Abbott Turkey
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2018
Primary Completion (Actual)
March 27, 2020
Study Completion (Actual)
March 27, 2020
Study Registration Dates
First Submitted
July 13, 2018
First Submitted That Met QC Criteria
July 13, 2018
First Posted (Actual)
July 24, 2018
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 2, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- DA16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastrointestinal Tolerance
-
Abbott NutritionCompleted
-
Abbott NutritionCompleted
-
Abbott NutritionActive, not recruiting
-
Cambridge GlycoscienceCompletedGastrointestinal ToleranceIreland
-
Tate & LyleBiofortis Innovation ServicesCompletedGastrointestinal ToleranceUnited States
-
Comet Bio Inc.Biofortis, Merieux NutriSciencesUnknownGastrointestinal Tolerance
-
Abbott NutritionCompleted
-
Abbott NutritionCompleted
-
Nutricia ResearchCompletedGastrointestinal TolerancePoland
-
Abbott NutritionCompleted