HealthyNCT00503789
The Effect of Infant Feeding on Stool Characteristics
A study testing fecal bacteria analysis in people with Healthy, run by Mead Johnson Nutrition at 23 sites in United States.
Trial summary
Infants will be fed infant formula and stool characteristics assessed. Read more about this study
- Who is it for?
- Ages 21 to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- fecal bacteria analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 23 sitesUnited States
- Study dates
- Aug 2007to Sep 2008
- 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 21 to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, term infants
- 21-30 days of age
Who cannot join
- Infants with feeding difficulties
- Use of antibiotics or steroids
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Altamonte Pediatric Associates
Altamonte Springs, Florida, 32701
Austin Diagnostic Clinic
Austin, Texas, 78745
Central Arkansas Pediatric Clinic
Benton, Arkansas, 72019
ACC Pediatric Research
Bossier City, Louisiana, 71111
Cary Pediatric Center, P.A.
Cary, North Carolina, 27511
Pediatric Associates of Mt. Carmel, Inc.
Cincinnati, Ohio, 45245
Alpha Clinical Research
Clarksville, Tennessee, 37043
Arkansas Pediatrics of Conway
Conway, Arkansas, 22401
Children's Hospital of Iowa
Coralville, Iowa, 52241
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, 45014
Internal Medicine and Pediatrics
Fishers, Indiana, 46038
East Washington Pediatrics
Indianapolis, Indiana, 46229
The Children's Clinic of Jonesboro
Jonesboro, Arkansas, 72401
ProMed Healthcare
Kalamazoo, Michigan, 49008
University of Kansas Medical University
Kansas City, Kansas, 66160
PTCU/Children and Youth Project
Louisville, Kentucky, 40202
Northeast Cincinnati Pediatric Assoc
Mason, Ohio, 45040
Winthrop Pediatric Associates
Mineola, New York, 11501
The Center for Human Nutrition
Omaha, Nebraska, 68105
Advocate Center for Pediatric Research
Park Ridge, Illinois, 60068
Red Lion Pediatrics
Philadelphia, Pennsylvania, 19114
ProMed Pediatrics
Portage, Michigan, 49024
ProMed Physicians-Pediatrics
Richland, Michigan, 49083
About this study
Infants will be fed infant formula and stool characteristics assessed.
- Conditions
- Healthy
- Being tested
- fecal bacteria analysis
- Keywords
- Healthy infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal bacteria analysisProcedure or surgery
ad lib feeding
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | cow-milk based infant formula Receives: Procedure: fecal bacteria analysis |
| 2 | Experimental | cow milk based infant formula with prebiotics Receives: Procedure: fecal bacteria analysis |
| 3 | Other | human milk reference group Receives: Procedure: fecal bacteria analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
fecal bacteria analysis
Measured: 60 days
Secondary outcomes (1)
Intake, tolerance, stool characteristics, anthropometrics
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Deolinda Scalabrin, MD, Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503789
- Sponsor's protocol ID
- 33715
- Status last verified
- Sep 2008
- First submitted
- 17 Jul 2007
- Last updated
- 5 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Salminen S, Endo A, Isolauri E, Scalabrin D. Early Gut Colonization With Lactobacilli and Staphylococcus in Infants: The Hygiene Hypothesis Extended. J Pediatr Gastroenterol Nutr. 2016 Jan;62(1):80-6. doi: 10.1097/MPG.0000000000000925.
PubMed 26230902Scalabrin DM, Mitmesser SH, Welling GW, Harris CL, Marunycz JD, Walker DC, Bos NA, Tolkko S, Salminen S, Vanderhoof JA. New prebiotic blend of polydextrose and galacto-oligosaccharides has a bifidogenic effect in young infants. J Pediatr Gastroenterol Nutr. 2012 Mar;54(3):343-52. doi: 10.1097/MPG.0b013e318237ed95.
PubMed 21946836
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Infant Feeding on Stool Characteristics
- ClinicalTrials.gov ID
- NCT00503789
- Acronym / sponsor ID
- 33715
- Conditions
- Healthy
- Keywords
- Healthy infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 19 Jul 2007 (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.
Infants will be fed infant formula and stool characteristics assessed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: fecal bacteria analysiscow-milk based infant formula |
| 2 | Experimental | Procedure: fecal bacteria analysiscow milk based infant formula with prebiotics |
| 3 | Other | Procedure: fecal bacteria analysishuman milk reference group |
Who may qualify
- Ages
- 21 to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy, term infants
- 21-30 days of age
Key exclusion criteria (2 listed)
- Infants with feeding difficulties
- Use of antibiotics or steroids
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 |
|---|---|---|
| fecal bacteria analysisad lib feeding | Procedure or surgery | 1, 2, 3 |
Primary outcome
fecal bacteria analysis
Time frame: 60 days
1 secondary outcome
Intake, tolerance, stool characteristics, anthropometrics
Time frame: 60 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 5 Sep 2008.
- Derived from this study: PubMed 26230902Salminen S, Endo A, Isolauri E, Scalabrin D. Early Gut Colonization With Lactobacilli and Staphylococcus in Infants: The Hygiene Hypothesis Extended. J Pediatr Gastroenterol Nutr. 2016 Jan;62(1):80-6. doi: 10.1097/MPG.0000000000000925.
- Derived from this study: PubMed 21946836Scalabrin DM, Mitmesser SH, Welling GW, Harris CL, Marunycz JD, Walker DC, Bos NA, Tolkko S, Salminen S, Vanderhoof JA. New prebiotic blend of polydextrose and galacto-oligosaccharides has a bifidogenic effect in young infants. J Pediatr Gastroenterol Nutr. 2012 Mar;54(3):343-52. doi: 10.1097/MPG.0b013e318237ed95.
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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.
Deolinda Scalabrin, MD study director
Mead Johnson Nutrition
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fecal bacteria analysis in people with Healthy, run by Mead Johnson Nutrition at 23 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 2 inclusion and 2 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 5 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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?
fecal bacteria analysis (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00503789, which also lists 2 linked publications.
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 5 Sep 2008.