Feeding IntoleranceNCT02028156
Feeding Intolerance in Formula-Fed Infants
A study testing Partially Hydrolyzed Infant Formula in people with Feeding Intolerance, run by Abbott Nutrition at 3 sites in China.
Trial summary
This is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance. Read more about this study
- Who is it for?
- Ages Up to 60 daysHealthy volunteers can take part
- Conditions the study is for
- Feeding Intolerance
- What is being tested?
- Partially Hydrolyzed Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 3 sitesChina
- Study dates
- Jan 2014to Aug 2014
- 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 60 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton full term birth with birth weight of > 2500g.
- Infant between 0 and 60 days of age.
- Discontinuation of medications that might affect gastrointestinal (GI) tolerance.
- Infant is exclusively formula-fed a full-lactose, intact cow milk protein-based infant formula (CMF) for less than 7 days prior to enrollment.
- Infant was fed according to protocol in Stage 1 of the study.
- Infant was identified as being fussy using the Intolerance Assessment Tool in Stage 1.
Who cannot join
- Chromosomal or major congenital anomalies.
- Suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
- Hospitalization, other than for delivery, prior to enrollment.
- Severe uncontrolled eczema, visible bloody stools or milk protein allergy prior to enrollment.
- More than 1 substitution of an infant formula other than full-lactose, intact cow milk formula (CMF) since birth.
- Use of a prokinetic drug within 7 days before enrollment.
- Infant's intolerance symptom was caused by another reason, for example known infection/illness, food allergy, or response to vaccination(s).
- Infant has immunization(s) within 3 days of enrollment in Stage 2.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Guangdong Women and Children Hospital
Guangzhou, Guangdong
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu
Xin Hua Hospital
Shanghai
About this study
Official title: Evaluation of Feeding Intolerance in Formula-Fed Infants: A Non-Randomized, Single-Group, Multi-Center Study
This is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance.
- Conditions
- Feeding Intolerance
- Being tested
- Partially Hydrolyzed Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partially Hydrolyzed Infant FormulaOther
Commercially available infant formula
| Study group | Role | What they receive |
|---|---|---|
| Partially Hydrolyzed Infant Formula | Experimental | Fed ad lib. Receives: Other: Partially Hydrolyzed Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Fussiness
Study phase 2; Parent completed questionnaire.
Measured: 0 to 15 days
Secondary outcomes (4)
Diarrhea
Study phase 1; Parent completed questionnaire.
Measured: 0 to 4 weeks
Constipation
Study phase 1; Parent completed questionnaire.
Measured: 0 to 4 weeks
Spit-up
Study phase 1; Parent completed questionnaire.
Measured: 0 to 4 weeks
Gassiness
Study phase 1; Parent completed questionnaire.
Measured: 0 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding IntoleranceStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shirley Li, MD, Study chair, Abbott Nutrition China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028156
- Sponsor's protocol ID
- DA06
- Status last verified
- Nov 2014
- First submitted
- 6 Dec 2013
- Last updated
- 7 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Feeding Intolerance in Formula-Fed Infants: A Non-Randomized, Single-Group, Multi-Center Study
- ClinicalTrials.gov ID
- NCT02028156
- Acronym / sponsor ID
- DA06
- Conditions
- Feeding Intolerance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 7 Jan 2014 (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 is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Partially Hydrolyzed Infant Formula | Experimental | Other: Partially Hydrolyzed Infant FormulaFed ad lib. |
Who may qualify
- Ages
- Up to 60 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Singleton full term birth with birth weight of > 2500g.
- Infant between 0 and 60 days of age.
- Discontinuation of medications that might affect gastrointestinal (GI) tolerance.
- Infant is exclusively formula-fed a full-lactose, intact cow milk protein-based infant formula (CMF) for less than 7 days prior to enrollment.
- Infant was fed according to protocol in Stage 1 of the study.
Key exclusion criteria (8 listed)
- Chromosomal or major congenital anomalies.
- Suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
- Hospitalization, other than for delivery, prior to enrollment.
- Severe uncontrolled eczema, visible bloody stools or milk protein allergy prior to enrollment.
- More than 1 substitution of an infant formula other than full-lactose, intact cow milk formula (CMF) since birth.
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 |
|---|---|---|
| Partially Hydrolyzed Infant FormulaCommercially available infant formula | Other | Partially Hydrolyzed Infant Formula |
Primary outcome
Improvement in Fussiness
Time frame: 0 to 15 days
Study phase 2; Parent completed questionnaire.
4 secondary outcomes
Diarrhea
Time frame: 0 to 4 weeks
Constipation
Time frame: 0 to 4 weeks
Spit-up
Time frame: 0 to 4 weeks
Gassiness
Time frame: 0 to 4 weeks
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2014.
Related trials for Feeding Intolerance
Recruiting
Effect of Blenderized Enteral Tube Feeds on Pediatric Upper Gastrointestinal Tract Physiology
Enteral Feeding Intolerance
Recruiting
Continuous Versus Intermittent Enteral Feeding and Gastric Residual Volume in Critically Ill Patients
Enteral Feeding Intolerance, Critical Illness
Active, not recruiting
Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
Multi Organ Failure, Exocrine Pancreatic Insufficiency
Not yet recruitingObservational study
Gut Microbiota Structure, Functional and Metabolic Profiles, and Composite Biomarkers in ICU Adults With Refractory Enteral Feeding Intolerance
Refractory Enteral Feeding Intolerance, Gut Microbiota
Not yet recruiting
Transcutaneous Auricular Stimulation Targeting Enteral Feeding Intolerance
Enteral Feeding Intolerance, ICU
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.
Shirley Li, MD study chair
Abbott Nutrition China
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partially Hydrolyzed Infant Formula in people with Feeding Intolerance, run by Abbott Nutrition at 3 sites in China.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 7 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Improvement in Fussiness (time frame: 0 to 15 days). 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 7 Nov 2014.