Gastrointestinal ToleranceNCT02322138
Gastrointestinal Tolerance of Infant Formula
A study testing Experimental 1 Infant Formula, Experimental 2 Infant Formula and Reference Group in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 10 sites in United States.
Trial summary
The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics. Read more about this study
- Who is it for?
- Ages Up to 8 daysHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tolerance
- What is being tested?
- Experimental 1 Infant Formula, Experimental 2 Infant Formula and Reference Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 10 sitesUnited States
- Study dates
- Jan 2015to Jun 2015
- 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 Up to 8 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant is judged to be in good health.
- Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
- Infant's birth weight was > 2490 g (~5 lbs 8 oz.).
- Infant is between 0 and 8 days of age at enrollment.
- Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) 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
- Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.
- Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.
- Mother intends to use a combination of breast and formula feeding.
- Participation in another study that has not been approved as a concomitant study by AN.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
White Oak Family Physicians DBA Asheboro Research Associates
Asheboro, North Carolina, 27203
Clinical Research Advantage/Colorado Springs Health Partners
Colorado Springs, Colorado, 80920
Tanner Memorial Clinic
Layton, Utah, 84041
Women's Clinic of Lincoln, PC.
Lincoln, Nebraska, 68510
Institute of Clinical Research
Mayfield Heights, Ohio, 44124
The Cleveland Pediatric Research Center, LLC
Middleburg Heights, Ohio, 44130
Michael W. Simon, M.D., PSC
Nicholasville, Kentucky, 40356
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360
SCORE Physician Alliance, LLC
St. Petersburg, Florida, 33710
W.O.M.B Watching Over Mothers and Babies
Tucson, Arizona, 85712
About this study
Official title: Gastrointestinal Tolerance of Formula Supplemented With Prebiotics
The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.
- Conditions
- Gastrointestinal Tolerance
- Being tested
- Experimental 1 Infant Formula, Experimental 2 Infant Formula, Reference Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental 1 Infant FormulaOther
Ready to feed infant formula to be fed ad-libitum
Experimental 2 Infant FormulaOther
Ready to feed infant formula to be fed ad-libitum
Reference GroupOther
Breast fed ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 Infant Formula | Experimental | Milk-based infant formula without prebiotics Receives: Other: Experimental 1 Infant Formula |
| Experimental 2 Infant Formula | Experimental | Milk-based infant formula with prebiotics Receives: Other: Experimental 2 Infant Formula |
| Human Milk-Fed Reference Group | Other | Breast fed infants Receives: Other: Reference Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Consistency Questionnaire
Questionnaire
Measured: Baseline to 35 Days of Age
Secondary outcomes (5)
Stools per Day Questionnaire
Questionnaire
Measured: Baseline to 35 Days of Age
Feeding Spit Up Questionnaire
Questionnaire
Measured: Baseline to 35 Days of Age
Weight
Measured
Measured: Baseline to 35 Days of Age
Length
Measured
Measured: Baseline to 35 Days of Age
Head Circumference
Measured
Measured: Baseline to 35 Days of Age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janice Kajzer, MS, RD, LD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322138
- Sponsor's protocol ID
- AL14
- Status last verified
- Jul 2015
- First submitted
- 17 Dec 2014
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastrointestinal Tolerance of Formula Supplemented With Prebiotics
- ClinicalTrials.gov ID
- NCT02322138
- Acronym / sponsor ID
- AL14
- Conditions
- Gastrointestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Dec 2014 (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.
The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 Infant Formula | Experimental | Other: Experimental 1 Infant FormulaMilk-based infant formula without prebiotics |
| Experimental 2 Infant Formula | Experimental | Other: Experimental 2 Infant FormulaMilk-based infant formula with prebiotics |
| Human Milk-Fed Reference Group | Other | Other: Reference GroupBreast fed infants |
Who may qualify
- Ages
- Up to 8 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infant is judged to be in good health.
- Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
- Infant's birth weight was > 2490 g (~5 lbs 8 oz.).
- Infant is between 0 and 8 days of age at enrollment.
- Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) as the sole source of nutrition for the duration of the study.
Key exclusion criteria (4 listed)
- Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.
- Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.
- Mother intends to use a combination of breast and formula feeding.
- Participation in another study that has not been approved as a concomitant study by AN.
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 |
|---|---|---|
| Experimental 1 Infant FormulaReady to feed infant formula to be fed ad-libitum | Other | Experimental 1 Infant Formula |
| Experimental 2 Infant FormulaReady to feed infant formula to be fed ad-libitum | Other | Experimental 2 Infant Formula |
| Reference GroupBreast fed ad libitum | Other | Human Milk-Fed Reference Group |
Primary outcome
Stool Consistency Questionnaire
Time frame: Baseline to 35 Days of Age
Questionnaire
5 secondary outcomes
Stools per Day Questionnaire
Time frame: Baseline to 35 Days of Age
Feeding Spit Up Questionnaire
Time frame: Baseline to 35 Days of Age
Weight
Time frame: Baseline to 35 Days of Age
Length
Time frame: Baseline to 35 Days of Age
Head Circumference
Time frame: Baseline to 35 Days of Age
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 23 Jul 2015.
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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.
Janice Kajzer, MS, RD, LD study chair
Abbott Nutrition
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental 1 Infant Formula, Experimental 2 Infant Formula and Reference Group in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 10 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 4 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 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Stool Consistency Questionnaire (time frame: Baseline to 35 Days of Age). 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 23 Jul 2015.