Gastrointestinal ToleranceNCT02746016
Effect of Formula on Infant Behavior
A study testing Infant Formula supplemented with Oligosaccharides in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 13 sites in United States.
Trial summary
This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants. Read more about this study
- Who is it for?
- Ages 7 to 42 daysHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tolerance
- What is being tested?
- Infant Formula supplemented with Oligosaccharides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 13 sitesUnited States
- Study dates
- Apr 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 42 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Coastal Pediatric Research
Charleston, South Carolina, 29414
Institute of Clinical Research, LLC
Cleveland, Ohio, 44124
Southeastern Pediatric Associates
Dothan, Alabama, 36305
Aventiv Research
Grove City, Ohio, 43123
Tanner Clinic
Layton, Utah, 84041
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510
DCOL Center for Clinical Research
Longview, Texas, 75605
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360
Florida Institute for Clinical Research, LLC
Orlando, Florida, 32825
Southwest Children's Research Associates, P.A.
San Antonio, Texas, 78229
Score Physician Alliance, LLC
St. Petersburg, Florida, 33710
Watching Over Mothers and Babies
Tucson, Arizona, 85712
About this study
Official title: Effect of Formula Supplemented With Oligosaccharides on Infant Behavior
This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.
- Conditions
- Gastrointestinal Tolerance
- Being tested
- Infant Formula supplemented with Oligosaccharides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Formula supplemented with OligosaccharidesOther
sole source nutrition
| Study group | Role | What they receive |
|---|---|---|
| Infant Formula supplemented with Oligosaccharides | Experimental | Ready to feed infant formula ; Feed ad libitum. Receives: Other: Infant Formula supplemented with Oligosaccharides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fussiness
Parent Questionnaires
Measured: Change from baseline (3 days prior to SD1) to within one day of initiation of study feeding (SD1)
Secondary outcomes (4)
Fussiness
Parent Questionnaires
Measured: Baseline to SDAY 29
Hours of daily crying
Parent Questionnaires
Measured: Baseline to SDAY 29
Gastrointestinal Tolerance
Parent Questionnaires
Measured: Baseline to SDAY 29
Stool Pattern
Parent Questionnaire
Measured: Baseline to SDAY 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marlene Borschel, PhD, RD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746016
- Sponsor's protocol ID
- AL19
- Status last verified
- Mar 2017
- First submitted
- 13 Apr 2016
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Formula Supplemented With Oligosaccharides on Infant Behavior
- ClinicalTrials.gov ID
- NCT02746016
- Acronym / sponsor ID
- AL19
- Conditions
- Gastrointestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Apr 2016 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infant Formula supplemented with Oligosaccharides | Experimental | Other: Infant Formula supplemented with OligosaccharidesReady to feed infant formula ; Feed ad libitum. |
Who may qualify
- Ages
- 7 to 42 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant Formula supplemented with Oligosaccharidessole source nutrition | Other | Infant Formula supplemented with Oligosaccharides |
Primary outcome
Fussiness
Time frame: Change from baseline (3 days prior to SD1) to within one day of initiation of study feeding (SD1)
Parent Questionnaires
4 secondary outcomes
Fussiness
Time frame: Baseline to SDAY 29
Hours of daily crying
Time frame: Baseline to SDAY 29
Gastrointestinal Tolerance
Time frame: Baseline to SDAY 29
Stool Pattern
Time frame: Baseline to SDAY 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Gastrointestinal Tolerance
Active, not recruiting
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A Pilot Study of Commercially Available Bowel Preparation Regimens Packaged and Ingested Via Vegan Capsules
Lower Gastrointestinal Disorder, Tolerance
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Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlene Borschel, PhD, RD study chair
Abbott Nutrition
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Formula supplemented with Oligosaccharides in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fussiness (time frame: Change from baseline (3 days prior to SD1) to within one day of initiation of study feeding (SD1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017; AzTrials last refreshed its copy on 29 Oct 2026.