Gastrointestinal ToleranceNCT02757924
Behavior of Infants Fed Formula Supplemented With Prebiotics
A study testing Infant formula supplemented with prebiotics in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 11 sites in United States.
Trial summary
To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on 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 prebiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 11 sitesUnited States
- Study dates
- May 2016to 2 May 2017
- 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 judged to be in good health.
- Subject is a singleton from a full-term birth with a gestational age of 37 - 42 weeks.
- Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.).
- Infant was identified by parents as very fussy or extremely fussy.
- Infant is exclusively formula-fed at time of study entry. 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 vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
Who cannot join
- An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Subject is taking and plans to continue medications, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect 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
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, 40004
Holston Medical Group
Bristol, Tennessee, 37620
Coastal Pediatric Research
Charleston, South Carolina, 29414
Southeastern Pediatric Associates
Dothan, Alabama, 36305
Deaconess Clinic, Inc.
Evansville, Indiana, 47713
Aventiv Research
Grove City, Ohio, 43123
Holston Medical Group
Kingsport, Tennessee, 37660
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510
Pensacola Research Consultants, Inc
Pensacola, Florida, 32503
Southwest Children's Research Associates, P.A.
San Antonio, Texas, 78229
Score Physician Alliance, LLC
St. Petersburg, Florida, 33710
About this study
Official title: Behavior of Infants Fed a Partially Hydrolyzed Formula Supplemented With Prebiotics
To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on symptoms of formula intolerance in healthy term infants.
- Conditions
- Gastrointestinal Tolerance
- Being tested
- Infant formula supplemented with prebiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formula supplemented with prebioticsOther
Sole source nutrition
| Study group | Role | What they receive |
|---|---|---|
| Infant formula supplemented with prebiotics | Experimental | infant formula powder, feed ad libitum Receives: Other: Infant formula supplemented with prebiotics |
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 study day 1) to within 1 day of initiation of study feeding
Secondary outcomes (4)
Fussiness
Parent Questionnaires
Measured: Baseline to Day 29
Hours of Daily Crying
Parent Questionnaires
Measured: Baseline to Day 29
Gastrointestinal Tolerance
Parent Questionnaires
Measured: Baseline to Day 29
Stool Pattern
Parent Questionnaires
Measured: Baseline to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startMay 2016
- Primary completion2 May 2017
- Study completion2 May 2017
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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marlene Borschel, PhD, RD, LD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757924
- Sponsor's protocol ID
- AL20
- Status last verified
- Jun 2017
- First submitted
- 28 Apr 2016
- Last updated
- 19 Jun 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 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior of Infants Fed a Partially Hydrolyzed Formula Supplemented With Prebiotics
- ClinicalTrials.gov ID
- NCT02757924
- Acronym / sponsor ID
- AL20
- Conditions
- Gastrointestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- 2 May 2017 (actual)
- Study completion
- 2 May 2017 (actual)
- First posted
- 2 May 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.
To observe the effects of partially hydrolyzed formula supplemented with oligosaccharides on 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 prebiotics | Experimental | Other: Infant formula supplemented with prebioticsinfant formula powder, feed ad libitum |
Who may qualify
- Ages
- 7 to 42 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subject is judged to be in good health.
- Subject is a singleton from a full-term birth with a gestational age of 37 - 42 weeks.
- Subject's birth weight was ≥ 2490 g (~5 lbs. 8 oz.).
- Infant was identified by parents as very fussy or extremely fussy.
- Infant is exclusively formula-fed at time of study entry. Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
Key exclusion criteria (6 listed)
- An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Subject is taking and plans to continue medications, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect 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 prebioticsSole source nutrition | Other | Infant formula supplemented with prebiotics |
Primary outcome
Fussiness
Time frame: Change from baseline (3 days prior to study day 1) to within 1 day of initiation of study feeding
Parent questionnaires
4 secondary outcomes
Fussiness
Time frame: Baseline to Day 29
Hours of Daily Crying
Time frame: Baseline to Day 29
Gastrointestinal Tolerance
Time frame: Baseline to Day 29
Stool Pattern
Time frame: Baseline to Day 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 19 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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, LD study chair
Abbott Nutrition
11 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 prebiotics in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 11 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 6 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 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 study day 1) to within 1 day of initiation of study feeding). 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 19 Jun 2017.