Gastrointestinal ToleranceNCT02401217
Tolerance of Healthy Infants Fed Infant Formulas
A study testing Phase 1- Arm 1 Infant Formula, Phase 2- Arm 2 Infant Formula and Phase 2- Arm 3 Infant Formula in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 6 sites in United States.
Trial summary
The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula. Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Gastrointestinal Tolerance
- What is being tested?
- Phase 1- Arm 1 Infant Formula, Phase 2- Arm 2 Infant Formula and Phase 2- Arm 3 Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2015to Sep 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 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Singleton from a full term birth with a gestational age of 37-42 weeks.
- Birth weight was > 2490 g (~5 lbs 8 oz).
- Age between 0 and 30 days at enrollment.
- Agreement to discontinue the use of medications (including over the counter [OTC], such as Mylicon® for gas), home remedies, herbal preparations or rehydration fluids that might affect GI tolerance for the duration of the study.
- Intention to feed the infant the study product as the sole source of nutrition for the duration of the study.
- Intention not to administer vitamin (other than Vitamin D) or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
- Voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
Who cannot join
- An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Infant treated with antibiotics.
- Participation in another study that has not been approved as a concomitant study by AN.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
White Oak Family Physicians DBA/Asheboro Research Associates
Asheboro, North Carolina, 27203
Tanner Memorial Clinic
Layton, Utah, 84041
Institute of Clinical Research, LLC
Mayfield Heights, Ohio, 44124
The Cleveland Pediatric Research Center, LLC
Middleburg Heights, Ohio, 44130
SCORE Physician Alliance LLC
St. Petersburg, Florida, 33710
W.O.M.B Watching Over Mothers and Babies
Tucson, Arizona, 85712
About this study
The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.
- Conditions
- Gastrointestinal Tolerance
- Being tested
- Phase 1- Arm 1 Infant Formula, Phase 2- Arm 2 Infant Formula, Phase 2- Arm 3 Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase 1- Arm 1 Infant FormulaOther
Powder infant formula
Phase 2- Arm 2 Infant FormulaOther
Powder infant formula
Phase 2- Arm 3 Infant FormulaOther
Powder infant formula
| Study group | Role | What they receive |
|---|---|---|
| Phase 1-Arm 1 Infant Formula | Experimental | Milk-based infant formula manufactured by an alternative method. Non-commercially available formula. To be fed ad libitum. Receives: Other: Phase 1- Arm 1 Infant Formula |
| Phase 2- Arm 2 Infant Formula | Active comparator | Milk-based infant formula using current manufacturing and ingredients. Non-commercially available formula. To be fed ad libitum. Receives: Other: Phase 2- Arm 2 Infant Formula |
| Phase 2- Arm 3 Infant Formula | Experimental | Milk-based infant formula using a new protein. Non-commercially available formula. To be fed ad libitum. Receives: Other: Phase 2- Arm 3 Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries
MRSC will be calculated from data recorded on daily stool records during the study. Stool consistencies will be assigned the following: 1=watery, 2=loose/mushy, 3=soft, 4=formed, 5=hard.
Measured: Change from Study Day 1 to Study Day 15
Secondary outcomes (6)
Mean Percentage of stools representing each stool consistency and color using parent reported diaries
Mean percentage of each recorded stool consistency (watery, loose/mushy, soft, formed, hard) and stool color (yellow, brown, green, black) will be calculated for each infant and then used to calculate for each group from daily data recorded on daily stool records during the study.
Measured: Change from Study Day 1 to Study Day 15
Mean predominant stool consistency and color measured using parent reported diaries
Mean predominant stool consistency and color for each infant calculated from data recorded on daily stool records during the study will be used to calculate the mean predominant stool consistency and color for each group.
Measured: Change from Study Day 1 to Study Day 15
Average number of stools per day measured using parent reported diaries
Average number of stools/day will be calculated for each group from data recorded on daily stool records during the study.
Measured: Change from Study Day 1 to Study Day 15
Mean percentages of feedings associated with spit-up and/or vomit measured using parent reported diaries.
Mean percentages of feedings associated with spit-up and/or vomiting will be calculated for each group from data recorded on daily formula intake records during the study.
Measured: Change from Study Day 1 to Study Day 15
Parental responses to Formula Satisfaction and Infant Feeding and Stool Patterns Questionnaires
Parental responses to individual question on the Formula Satisfaction Questionnaire will be calculated from data recorded on the questionnaire at Study Day 15
Measured: Change from Study Day 1 to Study Day 15
Parental assessment of infant feeding and stool patterns measured by the Infant Feeding and Stool Patterns Questionnaire.
Parental responses to individual question on the Feeding and Stool Patterns Questionnaire will be calculated from data recorded on the questionnaire at Study Day 15.
Measured: Change from 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 posted27 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015
- Study completionSep 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
- 126 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
- NCT02401217
- Sponsor's protocol ID
- AL12
- Status last verified
- Jan 2016
- First submitted
- 16 Mar 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Healthy Infants Fed Infant Formulas
- ClinicalTrials.gov ID
- NCT02401217
- Acronym / sponsor ID
- AL12
- Conditions
- Gastrointestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Mar 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.
The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1-Arm 1 Infant Formula | Experimental | Other: Phase 1- Arm 1 Infant FormulaMilk-based infant formula manufactured by an alternative method. Non-commercially available formula. To be fed ad libitum. |
| Phase 2- Arm 2 Infant Formula | Active comparator | Other: Phase 2- Arm 2 Infant FormulaMilk-based infant formula using current manufacturing and ingredients. Non-commercially available formula. To be fed ad libitum. |
| Phase 2- Arm 3 Infant Formula | Experimental | Other: Phase 2- Arm 3 Infant FormulaMilk-based infant formula using a new protein. Non-commercially available formula. To be fed ad libitum. |
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Singleton from a full term birth with a gestational age of 37-42 weeks.
- Birth weight was > 2490 g (~5 lbs 8 oz).
- Age between 0 and 30 days at enrollment.
- Agreement to discontinue the use of medications (including over the counter [OTC], such as Mylicon® for gas), home remedies, herbal preparations or rehydration fluids that might affect GI tolerance for the duration of the study.
- Intention to feed the infant the study product as the sole source of nutrition for the duration of the study.
Key exclusion criteria (3 listed)
- An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Infant treated with antibiotics.
- 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 |
|---|---|---|
| Phase 1- Arm 1 Infant FormulaPowder infant formula | Other | Phase 1-Arm 1 Infant Formula |
| Phase 2- Arm 2 Infant FormulaPowder infant formula | Other | Phase 2- Arm 2 Infant Formula |
| Phase 2- Arm 3 Infant FormulaPowder infant formula | Other | Phase 2- Arm 3 Infant Formula |
Primary outcome
Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries
Time frame: Change from Study Day 1 to Study Day 15
MRSC will be calculated from data recorded on daily stool records during the study. Stool consistencies will be assigned the following: 1=watery, 2=loose/mushy, 3=soft, 4=formed, 5=hard.
6 secondary outcomes
Mean Percentage of stools representing each stool consistency and color using parent reported diaries
Time frame: Change from Study Day 1 to Study Day 15
Mean predominant stool consistency and color measured using parent reported diaries
Time frame: Change from Study Day 1 to Study Day 15
Average number of stools per day measured using parent reported diaries
Time frame: Change from Study Day 1 to Study Day 15
Mean percentages of feedings associated with spit-up and/or vomit measured using parent reported diaries.
Time frame: Change from Study Day 1 to Study Day 15
Parental responses to Formula Satisfaction and Infant Feeding and Stool Patterns Questionnaires
Time frame: Change from Study Day 1 to Study Day 15
Parental assessment of infant feeding and stool patterns measured by the Infant Feeding and Stool Patterns Questionnaire.
Time frame: Change from 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 12 Jan 2016.
Related trials for Gastrointestinal Tolerance
RecruitingPhase 1
Neoadjuvant Hypofractionated Stereotactic Body Radiation Therapy Prior to Surgery for Hepatocellular Carcinoma: a Feasibility Study.
Hepatocellular Carcinoma
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
RecruitingPhase 1/2
TLI- and ATG-Enabled Minimization Protocol in Liver Transplantation
Liver Failure
Active, not recruiting
Milk Free From A1-Type β-Casein on Inflammation, Gastrointestinal Tolerance, and Pregnancy Outcomes
Healthy Pregnant Women
Active, not recruiting
Effect of Daily Erythritol Versus Sucrose Intake Over 5 Weeks on Glucose Tolerance in Adolescents
Insulin Resistance, Glucose Tolerance
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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase 1- Arm 1 Infant Formula, Phase 2- Arm 2 Infant Formula and Phase 2- Arm 3 Infant Formula in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 6 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 7 inclusion and 3 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 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries (time frame: Change from 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 12 Jan 2016.