Gastrointestinal Tolerance Clinical Trial
Official title:
Effect of Formula Supplemented With Oligosaccharides on Infant Behavior
Verified date | March 2017 |
Source | Abbott Nutrition |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.
Status | Completed |
Enrollment | 69 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 42 Days |
Eligibility |
Inclusion Criteria: - Subject is in good health as determined from subject's medical history by parent report - Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks - Subject's birth weight was = 2490 g (~5 lbs. 8 oz.) - Subject is between 7 and 42 days of age - Infant was identified by parents as very fussy or extremely fussy in the baseline tolerance evaluation - Infant is exclusively formula-fed at time of study entry - Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study - Subject's parent(s) has voluntarily signed and dated an informed consent form (ICF) prior to any participation in the study Exclusion Criteria: - An adverse maternal, fetal or subject medical history that has potential for effects on tolerance, growth, and/or development - Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance - Subject participates in another study that has not been approved as a concomitant study - Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment - Subject has been treated with oral antibiotics within 7 days prior to study enrollment - Mother intends to use a combination of breast and formula feeding |
Country | Name | City | State |
---|---|---|---|
United States | Alabama Clinical Therapeutics, LLC | Birmingham | Alabama |
United States | Coastal Pediatric Research | Charleston | South Carolina |
United States | Institute of Clinical Research, LLC | Cleveland | Ohio |
United States | Southeastern Pediatric Associates | Dothan | Alabama |
United States | Aventiv Research | Grove City | Ohio |
United States | Tanner Clinic | Layton | Utah |
United States | Women's Clinic of Lincoln, PC | Lincoln | Nebraska |
United States | DCOL Center for Clinical Research | Longview | Texas |
United States | Norwich Pediatric Group, PC | Norwich | Connecticut |
United States | Florida Institute for Clinical Research, LLC | Orlando | Florida |
United States | Score Physician Alliance, LLC | Saint Petersburg | Florida |
United States | Southwest Children's Research Associates, P.A. | San Antonio | Texas |
United States | Watching Over Mothers and Babies | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Abbott Nutrition |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fussiness | Parent Questionnaires | Change from baseline (3 days prior to SD1) to within one day of initiation of study feeding (SD1) | |
Secondary | Fussiness | Parent Questionnaires | Baseline to SDAY 29 | |
Secondary | Hours of daily crying | Parent Questionnaires | Baseline to SDAY 29 | |
Secondary | Gastrointestinal Tolerance | Parent Questionnaires | Baseline to SDAY 29 | |
Secondary | Stool Pattern | Parent Questionnaire | Baseline to SDAY 29 |
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