Gastrointestinal ToleranceNCT02456831

Soy Formula Feedings in Healthy, Term Infants

A study testing Experimental Infant Formula 1, Experimental Infant Formula 2 and Experimental Infant Formula 3 in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula. Read more about this study

Who is it for?: Ages 2 to 9 weeks
Conditions the study is for: Gastrointestinal Tolerance
What is being tested?: Experimental Infant Formula 1, Experimental Infant Formula 2 and Experimental Infant Formula 3
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: 7 sitesUnited States
Study dates: Dec 1992to Jun 1994
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 2 to 9 weeks
All sexes
No healthy volunteers
Child

Who may be able to join

Healthy infants believed by their parents and/or physicians to be experiencing symptoms of cow's milk formula intolerance and who had not previously consumed a soy-based formula (Intervention subjects).
Health infants reported to be tolerating a milk-based formula (Cohorts).
Infants considered full-term, 2 to 9 weeks of age with a birth-weight above the 5th percentile (NCHS).

Who cannot join

None listed.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Dreyer Clinic
Aurora, Illinois, 60506
Clinical Studies, Inc
Canton, Ohio, 44709
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Research Memphis
Memphis, Tennessee, 38119
Park Nicollet Medical Foundation
Minneapolis, Minnesota, 55416
T&W Research
Owensboro, Kentucky, 42302
Child Care Associates
San Antonio, Texas, 78212

Other trials in United States

About this study

Official title: Efficacy of Soy Formula Feedings in Healthy, Term Infants

This study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.

Conditions: Gastrointestinal Tolerance
Being tested: Experimental Infant Formula 1, Experimental Infant Formula 2, Experimental Infant Formula 3, Active Comparator: Control Infant Formula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental Infant Formula 1Other
method A phytate reduction and 5% protein hydrolysis
Experimental Infant Formula 2Other
method A phytate reduction and 10% protein hydrolysis
Experimental Infant Formula 3Other
method B phytate reduction and 5% protein hydrolysis
Active Comparator: Control Infant FormulaOther
Ready-to-Feed (RTF) Soy Infant Formula

Study groups in NCT02456831
Study group	Role	What they receive
Control Infant Formula	Active comparator	Ready-to-Feed (RTF) Soy Infant Formula Receives: Other: Active Comparator: Control Infant Formula
Experimental Infant Formula 1	Experimental	Experimental Ready-to-Feed Soy Formula Receives: Other: Experimental Infant Formula 1
Experimental Infant Formula 2	Experimental	Experimental Ready-to-Feed Soy Formula Receives: Other: Experimental Infant Formula 2
Experimental Infant Formula 3	Experimental	Experimental Ready-to-Feed Soy Formula Receives: Other: Experimental Infant Formula 3

What is being measured

The primary outcome is the main question the study is designed to answer.

Stool Characteristics Questionnaire
stool number, consistency, and color
Measured: Change from Baseline (Study Day 1) to Study Day 15

Secondary outcomes (3)

Formula Intake
volume consumed
Measured: Change from Baseline (Study Day 1) to Study Day 15
Gastrointestinal Tolerance Questionnaire
Incidence of spit up and vomiting
Measured: Change from Baseline (Study Day 1) to Study Day 15
Weight
weight and weight gain
Measured: Change from Baseline (Study Day 1) to Study Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 1992Jun 1994

First posted29 May 2015 (estimated)
Study startDec 1992
Primary completionJun 1994
Study completionJun 1994

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: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02456831
Sponsor's protocol ID: AE58
Status last verified: May 2015
First submitted: 27 May 2015
Last updated: 29 May 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Soy Formula Feedings in Healthy, Term Infants
ClinicalTrials.gov ID: NCT02456831
Acronym / sponsor ID: AE58
Conditions: Gastrointestinal Tolerance
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: Abbott NutritionIndustry (pharma, biotech, devices)
Study start: Dec 1992
Primary completion: Jun 1994 (actual)
Study completion: Jun 1994 (actual)
First posted: 29 May 2015 (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 study evaluates the GI tolerance and acceptability of soy formulas fed to healthy term infants with reported intolerance to a milk-based formula.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Control Infant Formula	Active comparator	Other: Active Comparator: Control Infant FormulaReady-to-Feed (RTF) Soy Infant Formula
Experimental Infant Formula 1	Experimental	Other: Experimental Infant Formula 1Experimental Ready-to-Feed Soy Formula
Experimental Infant Formula 2	Experimental	Other: Experimental Infant Formula 2Experimental Ready-to-Feed Soy Formula
Experimental Infant Formula 3	Experimental	Other: Experimental Infant Formula 3Experimental Ready-to-Feed Soy Formula

Who may qualify

Ages: 2 to 9 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Healthy infants believed by their parents and/or physicians to be experiencing symptoms of cow's milk formula intolerance and who had not previously consumed a soy-based formula (Intervention subjects).
Health infants reported to be tolerating a milk-based formula (Cohorts).
Infants considered full-term, 2 to 9 weeks of age with a birth-weight above the 5th percentile (NCHS).

Key exclusion criteria (0 listed)

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 Infant Formula 1method A phytate reduction and 5% protein hydrolysis	Other	Experimental Infant Formula 1
Experimental Infant Formula 2method A phytate reduction and 10% protein hydrolysis	Other	Experimental Infant Formula 2
Experimental Infant Formula 3method B phytate reduction and 5% protein hydrolysis	Other	Experimental Infant Formula 3
Active Comparator: Control Infant FormulaReady-to-Feed (RTF) Soy Infant Formula	Other	Control Infant Formula

Primary outcome

Stool Characteristics Questionnaire
Time frame: Change from Baseline (Study Day 1) to Study Day 15
stool number, consistency, and color

3 secondary outcomes

Formula Intake
Time frame: Change from Baseline (Study Day 1) to Study Day 15
Gastrointestinal Tolerance Questionnaire
Time frame: Change from Baseline (Study Day 1) to Study Day 15
Weight
Time frame: Change from Baseline (Study Day 1) to Study Day 15

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 29 May 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.

John Lasekan, MBA, PhD, CCRP study chair

Abbott Nutrition

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 0 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 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 Characteristics Questionnaire (time frame: Change from Baseline (Study Day 1) to Study Day 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02456831.

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 29 May 2015.