Gastrointestinal ToleranceNCT02456805
Alternate Formula Feedings in Formula Intolerant Infants
A study testing Infant Formula 1 and Infant Formula 2 in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 8 sites in 2 countries.
Trial summary
This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding. 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?
- Infant Formula 1 and Infant Formula 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Aug 1996to Jun 1997
- 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
- Infants formula-fed exclusively and experiencing symptoms of cow's milk formula intolerance.
- Infants whose physicians had made a recommendation that the parents change the infant's feeding.
- Full term infants at birth with a gestational age of 37 to 42 weeks.
- Infants 2- 9 weeks of age at study entry with birth weights greater than 2500 grams.
Who cannot join
- Infants with a maternal medical history which had adverse effects on the fetus, such as diabetes, tuberculosis, perinatal infections, or substance abuse.
- Infants with evidence of cardiac, respiratory, gastrointestinal, hematological, or metabolic disease.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Aurora Pediatric Associates
Aurora, Colorado, 80011
Clinical Studies, Inc
Canton, Ohio, 44709
The Medical Associates Clinic
Dubuque, Iowa, 52001
Arkansas Children's Hospital
Little Rock, Alaska, 72202
Richmond Pediatrics
Richmond, Virginia, 23294
Baystate Medical Center, Children's Hospital
Springfield, Massachusetts, 01199
Northlake Pediatric, Associates
Stone Mountain, Georgia, 30087
About this study
Official title: Efficacy of Alternate Formula Feedings in Formula Intolerant Infants
This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.
- Conditions
- Gastrointestinal Tolerance
- Being tested
- Infant Formula 1, Infant Formula 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Formula 1Other
Feed ab libitum
Infant Formula 2Other
Feed ab libitum
| Study group | Role | What they receive |
|---|---|---|
| Infant Formula 1 | Active comparator | A standard commercial milk-based infant formula Receives: Other: Infant Formula 1 |
| Infant Formula 2 | Experimental | A standard commercial soy-based infant formula. Receives: Other: Infant Formula 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Characteristics
Parent questionnaire
Measured: Change from Baseline (Study Day 1) to Study Day 15
Secondary outcomes (3)
Formula Intake
Parent questionnaire on volume consumed
Measured: Change from Baseline (Study Day 1) to Study Day 15
Incidence of spit up/vomiting
Parent questionnaire
Measured: Change from Baseline (Study Day 1) to Study Day 15
Weight
Measured weight at visits
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.
- First posted29 May 2015 (estimated)
- Study startAug 1996
- Primary completionJun 1997
- Study completionJun 1997
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
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Lasekan, MBA, Ph.D, CCRP, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456805
- Sponsor's protocol ID
- AH23
- Status last verified
- May 2015
- First submitted
- 27 May 2015
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- No
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 Alternate Formula Feedings in Formula Intolerant Infants
- ClinicalTrials.gov ID
- NCT02456805
- Acronym / sponsor ID
- AH23
- Conditions
- Gastrointestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Aug 1996
- Primary completion
- Jun 1997 (actual)
- Study completion
- Jun 1997 (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 assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant Formula 1 | Active comparator | Other: Infant Formula 1A standard commercial milk-based infant formula |
| Infant Formula 2 | Experimental | Other: Infant Formula 2A standard commercial soy-based infant formula. |
Who may qualify
- Ages
- 2 to 9 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants formula-fed exclusively and experiencing symptoms of cow's milk formula intolerance.
- Infants whose physicians had made a recommendation that the parents change the infant's feeding.
- Full term infants at birth with a gestational age of 37 to 42 weeks.
- Infants 2- 9 weeks of age at study entry with birth weights greater than 2500 grams.
Key exclusion criteria (2 listed)
- Infants with a maternal medical history which had adverse effects on the fetus, such as diabetes, tuberculosis, perinatal infections, or substance abuse.
- Infants with evidence of cardiac, respiratory, gastrointestinal, hematological, or metabolic disease.
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 1Feed ab libitum | Other | Infant Formula 1 |
| Infant Formula 2Feed ab libitum | Other | Infant Formula 2 |
Primary outcome
Stool Characteristics
Time frame: Change from Baseline (Study Day 1) to Study Day 15
Parent questionnaire
3 secondary outcomes
Formula Intake
Time frame: Change from Baseline (Study Day 1) to Study Day 15
Incidence of spit up/vomiting
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.
Related trials for Gastrointestinal Tolerance
Active, not recruiting
Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents
Insulin Resistance, Glucose Tolerance
Not yet recruitingEarly Phase 1
A Pilot Study of Commercially Available Bowel Preparation Regimens Packaged and Ingested Via Vegan Capsules
Lower Gastrointestinal Disorder, Tolerance
Not yet recruiting
Gastrointestinal Symptoms and Tolerance in Infants Fed Goat or Cow's Milk-based Infant Formula
Gastrointestinal Tolerance, Gastrointestinal Symptoms
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, Ph.D, CCRP study chair
Abbott Nutrition
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Formula 1 and Infant Formula 2 in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 8 sites in 2 countries.
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 4 inclusion and 2 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 8 sites in United States, Canada. 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 (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?
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; AzTrials last refreshed its copy on 2 Nov 2026.