Gastro-Intestinal ToleranceNCT04915937
Formula Tolerance of Term Infants
A study testing Study Infant Formula in people with Gastro-Intestinal Tolerance, run by Abbott Nutrition at 12 sites in United States.
Trial summary
To assess the effects of infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants Read more about this study
- Who is it for?
- Ages 7 to 65 daysHealthy volunteers can take part
- Conditions the study is for
- Gastro-Intestinal Tolerance
- What is being tested?
- Study Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 12 sitesUnited States
- Study dates
- 13 Jul 2021to 22 Nov 2022
- 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 65 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant is judged to be in good health as determined from participant's medical history by parent report
- Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
- Participant's birth weight was >= 2490 g (~5 lbs. 8 oz.)
- Participant was identified by parents as very fussy or extremely fussy in the Baseline Tolerance Evaluation on a formula-feed
- Participant is exclusively formula-fed at time of study entry and Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
- Parent(s) confirm their intention not to administer vitamin, mineral, human milk oligosaccharide(s) (HMO), prebiotic(s), or probiotic(s) supplements (with the exception of vitamin D supplements if instructed by their healthcare professional), non-study formula, foods, juices, or other sources of nutrition to their infant from enrollment through the duration of the study
- Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC) and provided applicable local privacy regulation authorization prior to any participation in the study
Who cannot join
- An adverse maternal, fetal, or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. This includes but is not limited to suspected maternal substance abuse.
- Participant is taking and plans to continue taking medications (including OTC, such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, or rehydration fluids that might affect GI tolerance.
- Participant participates in another study that has not been approved as a concomitant study
- Participant has been fed a formula with greater than 2 HMOs prior to study enrollment
- Participant has been fed an extensively hydrolyzed, amino acid based, or preterm formula within 14 days prior to study enrollment and/or an extensively hydrolyzed, amino acid based, or preterm formula has been recommended by the physician.
- Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
- Participant has been treated with antibiotics within 7 days prior to enrollment
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
MedPharmics
Covington, Louisiana, 70433
Invesclinic US LLC
Edinburg, Texas, 78539
Meridian Clinical Research
Hastings, Nebraska, 68901
Clinical Research Prime
Idaho Falls, Idaho, 83404
Boeson Research Kalispell
Kalispell, Montana, 59901
Maximos Ob/Gyn
League City, Texas, 77573
Be Well Clinical Studies
Lincoln, Nebraska, 68516
Meridian Clincial Research- Macan
Macon, Georgia, 31210
AVIATI Healthcare & Clinical Research
Memphis, Tennessee, 38115
Dade Research Center, LLC
Miami, Florida, 33126
Springs Medical Research
Owensboro, Kentucky, 42303
MedPharmics, LLC
Phoenix, Arizona, 85015
About this study
Official title: Tolerance of Term Infants Fed Formula With Oligosaccharides
To assess the effects of infant formula with oligosaccharides on symptoms of formula intolerance in healthy, term infants
- Conditions
- Gastro-Intestinal Tolerance
- Being tested
- Study Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Infant FormulaOther
RTF milk-based infant formula with oligosaccharides
| Study group | Role | What they receive |
|---|---|---|
| Study Infant Formula | Experimental | Feed ad libitum during study period Receives: Other: Study Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fussiness
Absolute and % change in fussiness severity reported from Daily Tolerance Diary
Measured: Baseline to Study Day (SDAY) 2
Secondary outcomes (2)
Gastrointestinal Tolerance
Parent Completed Diary
Measured: Baseline to SDAY 28
Stool
Parent Completed Diary
Measured: Baseline to SDAY 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start13 Jul 2021
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Intestinal 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Reverri, PhD, MS, RD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915937
- Sponsor's protocol ID
- AL41
- Status last verified
- Dec 2022
- First submitted
- 1 Jun 2021
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Term Infants Fed Formula With Oligosaccharides
- ClinicalTrials.gov ID
- NCT04915937
- Acronym / sponsor ID
- AL41
- Conditions
- Gastro-Intestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 7 Jun 2021 (actual)
- 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 assess the effects of infant formula 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 |
|---|---|---|
| Study Infant Formula | Experimental | Other: Study Infant FormulaFeed ad libitum during study period |
Who may qualify
- Ages
- 7 to 65 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Participant is judged to be in good health as determined from participant's medical history by parent report
- Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
- Participant's birth weight was >= 2490 g (~5 lbs. 8 oz.)
- Participant was identified by parents as very fussy or extremely fussy in the Baseline Tolerance Evaluation on a formula-feed
- Participant is exclusively formula-fed at time of study entry and Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
Key exclusion criteria (7 listed)
- An adverse maternal, fetal, or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development. This includes but is not limited to suspected maternal substance abuse.
- Participant is taking and plans to continue taking medications (including OTC, such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations, or rehydration fluids that might affect GI tolerance.
- Participant participates in another study that has not been approved as a concomitant study
- Participant has been fed a formula with greater than 2 HMOs prior to study enrollment
- Participant has been fed an extensively hydrolyzed, amino acid based, or preterm formula within 14 days prior to study enrollment and/or an extensively hydrolyzed, amino acid based, or preterm formula has been recommended by the physician.
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 |
|---|---|---|
| Study Infant FormulaRTF milk-based infant formula with oligosaccharides | Other | Study Infant Formula |
Primary outcome
Fussiness
Time frame: Baseline to Study Day (SDAY) 2
Absolute and % change in fussiness severity reported from Daily Tolerance Diary
2 secondary outcomes
Gastrointestinal Tolerance
Time frame: Baseline to SDAY 28
Stool
Time frame: Baseline to SDAY 28
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 20 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Elizabeth Reverri, PhD, MS, RD study chair
Abbott Nutrition
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Infant Formula in people with Gastro-Intestinal Tolerance, run by Abbott Nutrition at 12 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 7 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 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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: Baseline to Study Day (SDAY) 2). 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 20 Dec 2022.