Gastrointestinal ToleranceNCT03628183
Tolerance of Infants Fed a Hydrolysate Formula
A study testing Hydrolysate Infant Formula 1 and Hydrolysate Infant Formula 2 in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 5 sites in United States.
Trial summary
This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas. Read more about this study
- Who is it for?
- Ages Up to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tolerance
- What is being tested?
- Hydrolysate Infant Formula 1 and Hydrolysate Infant Formula 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Aug 2018to 23 Nov 2018
- 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 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject is judged to be in good health
- Singleton from a full-term birth
- Birth weight was > or = to 2490 g
- Between 0 and 14 days of age at enrollment
- Parent(s) confirm their intention to feed their infant the assigned study product 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
- Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF)
Who cannot join
- An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- Subject participates in another study that has not been approved as a concomitant study
- Subject has an allergy or intolerance to any ingredient in the study product
- Subject has been treated with antibiotics within 2 weeks prior to enrollment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The Cleveland Pediatric Research Center, LLC
Cleveland, Ohio, 44130
Midsouth Center for Clinical Research
Memphis, Tennessee, 38116
Institute of Clinical Research, LLC
Mentor, Ohio, 44060
Springs Medical Research
Owensboro, Kentucky, 42303
Watching Over Mothers and Babies
Tucson, Arizona, 85712
About this study
Official title: Tolerance of Infants Fed a Hydrolysate Formula Manufactured With a New Processing Method
This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.
- Conditions
- Gastrointestinal Tolerance
- Being tested
- Hydrolysate Infant Formula 1, Hydrolysate Infant Formula 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolysate Infant Formula 1Other
Feed ad lib
Hydrolysate Infant Formula 2Other
Feed ad lib
| Study group | Role | What they receive |
|---|---|---|
| Hydrolysate Infant Formula 1 | Active comparator | Ready to feed infant formula in can Receives: Other: Hydrolysate Infant Formula 1 |
| Hydrolysate Infant Formula 2 | Experimental | Ready to feed infant formula in bottle Receives: Other: Hydrolysate Infant Formula 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool Characteristics
Parent completed diary
Measured: Study Day 1 - Study Day 21
Secondary outcomes (3)
Formula Intake
Parent completed diary
Measured: Study Day 1 - Study Day 21
Weight
Scale
Measured: Study Day 1 - Study Day 21
Length
Length board
Measured: Study Day 1 - Study Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start28 Aug 2018
- Primary completion23 Nov 2018
- Study completion23 Nov 2018
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Courtney Allgeier, MS, RD, LD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628183
- Sponsor's protocol ID
- AL30
- Status last verified
- Dec 2018
- First submitted
- 13 Jul 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Infants Fed a Hydrolysate Formula Manufactured With a New Processing Method
- ClinicalTrials.gov ID
- NCT03628183
- Acronym / sponsor ID
- AL30
- Conditions
- Gastrointestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 23 Nov 2018 (actual)
- First posted
- 14 Aug 2018 (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.
This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydrolysate Infant Formula 1 | Active comparator | Other: Hydrolysate Infant Formula 1Ready to feed infant formula in can |
| Hydrolysate Infant Formula 2 | Experimental | Other: Hydrolysate Infant Formula 2Ready to feed infant formula in bottle |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subject is judged to be in good health
- Singleton from a full-term birth
- Birth weight was > or = to 2490 g
- Between 0 and 14 days of age at enrollment
- Parent(s) confirm their intention to feed their infant the assigned study product as the sole source of nutrition for the duration of the study
Key exclusion criteria (5 listed)
- An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- Subject participates in another study that has not been approved as a concomitant study
- Subject has an allergy or intolerance to any ingredient in the study product
- Subject has been treated with antibiotics within 2 weeks prior to enrollment
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 |
|---|---|---|
| Hydrolysate Infant Formula 1Feed ad lib | Other | Hydrolysate Infant Formula 1 |
| Hydrolysate Infant Formula 2Feed ad lib | Other | Hydrolysate Infant Formula 2 |
Primary outcome
Stool Characteristics
Time frame: Study Day 1 - Study Day 21
Parent completed diary
3 secondary outcomes
Formula Intake
Time frame: Study Day 1 - Study Day 21
Weight
Time frame: Study Day 1 - Study Day 21
Length
Time frame: Study Day 1 - Study Day 21
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 19 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Courtney Allgeier, MS, RD, LD study chair
Abbott Nutrition
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolysate Infant Formula 1 and Hydrolysate Infant Formula 2 in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 5 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 5 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 (time frame: Study Day 1 - Study Day 21). 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 19 Dec 2018.