Tolerance of an Oral Nutritional Supplement(ONS)With a New Protein Blend in Healthy Children

Abbott Nutrition1 site in 1 country25 target enrollmentMarch 2013

ConditionsGastro-Intestinal Tolerance

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastro-Intestinal Tolerance
Sponsor: Abbott Nutrition
Enrollment: 25
Locations: 1
Primary Endpoint: Gastro-Intestinal Tolerance
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to capture information on gastrointestinal tolerance (GI) of an oral nutritional supplement containing a new protein blend in healthy children aged ≥ 3 to ≤ 10 years.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott Nutrition

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 3 and ≤ 10 years of age
•Healthy and not suffering from any physical disability.
•Height-for-age and BMI-for-age between the 5th and the 95th percentile as well as a weight-for-age between the 5th and the 85th percentile
•Consumption of 2 servings/day of the investigational product for 7 consecutive days
•Willingness to follow the study procedures and record the data in the diary and complete any forms or assessment as needed throughout the study
•Agreement to not consume a nutritional product that is not study product during the study period

Exclusion Criteria

•History of an acute or chronic condition that may affect feeding habits or nutritional status
•Medications or nutritional supplements, taken on a daily basis for more than 2 weeks during the past month prior to screening visit that may profoundly affect feeding habits or nutritional status
•Clinically significant nutritional deficiency requiring specific treatment
•Acute/chronic condition requiring medical treatment which may include hospitalization such as diabetes or stress induced hyperglycemia, dialysis treatment, inflammatory bowel disease, pancreatitis, autoimmune disease or immunodeficiency, celiac disease, cystic fibrosis, active tuberculosis, malformation of the gastrointestinal tract or gastroesophageal reflux disease
•History of constipation
•Allergy or intolerance to any ingredient in the study product
•Gastrointestinal infection or acute diarrhea at the time of study start
•Hepatitis B or C, or HIV, or malignancy
•Congenital cardiac defects
•Antibiotic therapy within last 2 weeks of start of study