StoolNCT03223792
Acceptance Of A Partially-Hydrolyzed Infant Formula
A study testing Investigational in people with Stool, run by Mead Johnson Nutrition at 11 sites in United States.
Trial summary
This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period. Read more about this study
- Who is it for?
- Ages 28 to 300 daysHealthy volunteers can take part
- Conditions the study is for
- Stool
- What is being tested?
- Investigational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 11 sitesUnited States
- Study dates
- 21 Aug 2017to 31 Dec 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 28 to 300 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton 28-300 days of age at randomization
- Gestational age less than or equal to 35 weeks
- Receiving minimum 18oz infant formula in the 24hrs prior to randomization
- History of hard stools or stooling difficulty
- Signed informed consent and protected health information
Who cannot join
- Current diagnosis of cow's milk protein allergy or intolerance
- Use of extensively hydrolyzed or amino acid formula at randomization
- Any abdominal or gastrointestinal surgery prior to randomization
- History of underlying metabolic or chronic disease or congenital malformation
- Organic causes of constipation
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Kentucky Pediatrics/Adult Research
Bardstown, Kentucky, 40004
Birmingham Pediatric Associates
Birmingham, Alabama, 35205
Coastal Pediatric Research
Charleston, South Carolina, 29414
Ohio Pediatric Research Association
Dayton, Ohio, 45414
Southeastern Pediatric Associates
Dothan, Alabama, 36305
Deaconess Clinical Research
Evansville, Indiana, 47725
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, 72703
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401
DCOL Center for Clinical Research
Longview, Texas, 75605
Deaconess Clinic
Newburgh, Indiana, 47630
Owensboro Pediatrics
Owensboro, Kentucky, 42303
About this study
This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.
- Conditions
- Stool
- Being tested
- Control, Investigational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Routine cow's milk-based infant formula
InvestigationalOther
Partially-hydrolyzed cow's milk protein infant formula
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Other: Control |
| Investigational | Experimental | Not described Receives: Other: Investigational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool consistency measured by MJN stool consistency scale
Measured: 14 days
Secondary outcomes (5)
Stool frequency
Measured: 14 days
Formula acceptance measured by intake diary
Measured: 14 days
Formula gastrointestinal tolerance measured by diary
Measured: 14 days
Bowel movement characteristics by diary
Measured: 14 days
Medically confirmed adverse events throughout the study period
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start21 Aug 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StoolStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Wu, Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223792
- Sponsor's protocol ID
- 3389-1
- Status last verified
- Jan 2019
- First submitted
- 12 Jul 2017
- Last updated
- 9 Jan 2019
- 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 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance Of A Partially-Hydrolyzed Infant Formula
- ClinicalTrials.gov ID
- NCT03223792
- Acronym / sponsor ID
- 3389-1
- Conditions
- Stool
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 21 Jul 2017 (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 clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control |
| Investigational | Experimental | Other: Investigational |
Who may qualify
- Ages
- 28 to 300 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Singleton 28-300 days of age at randomization
- Gestational age less than or equal to 35 weeks
- Receiving minimum 18oz infant formula in the 24hrs prior to randomization
- History of hard stools or stooling difficulty
- Signed informed consent and protected health information
Key exclusion criteria (5 listed)
- Current diagnosis of cow's milk protein allergy or intolerance
- Use of extensively hydrolyzed or amino acid formula at randomization
- Any abdominal or gastrointestinal surgery prior to randomization
- History of underlying metabolic or chronic disease or congenital malformation
- Organic causes of constipation
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 |
|---|---|---|
| ControlRoutine cow's milk-based infant formula | Other | Control |
| InvestigationalPartially-hydrolyzed cow's milk protein infant formula | Other | Investigational |
Primary outcome
Stool consistency measured by MJN stool consistency scale
Time frame: 14 days
5 secondary outcomes
Stool frequency
Time frame: 14 days
Formula acceptance measured by intake diary
Time frame: 14 days
Formula gastrointestinal tolerance measured by diary
Time frame: 14 days
Bowel movement characteristics by diary
Time frame: 14 days
Medically confirmed adverse events throughout the study period
Time frame: 14 days
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 9 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Stool
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
Not yet recruitingPhase 4
Evaluation of the Impact of Oral Ivermectin on Musca Sorbens Flies, Putative Vector of Trachoma
Survival of Flies Developing in Faecal Samples
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruiting
Aimmune Longitudinal Collaboration Study
Stool Spore Colony Forming Units, Microbiome Composition
Active, not recruitingObservational study
Characterization of Vaginal, Urinary and Fecal Microbiomes in Women With Recurrent Urinary Tract Infections
Urinary Tract Infections, Menopause
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.
Steven Wu study director
Mead Johnson Nutrition
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational in people with Stool, run by Mead Johnson Nutrition at 11 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 5 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 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 MJN stool consistency scale (time frame: 14 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 9 Jan 2019.