Stool OutputNCT01081067
Assessment of Efficiency and Safety of an Infant Formula Containing a Probiotic in Children
An observational study of Stool Output, run by Mead Johnson Nutrition at 1 site in Brazil.
Trial summary
Evaluate the effect of probiotics on stool output in children 1 - 18 months old. Read more about this study
- Who is it for?
- Ages 1 month to 18 months
- Conditions the study is for
- Stool Output
- How many people
- 134 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2007to Dec 2010
- Phase
- Observational
- 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 1 month to 18 months
- All sexes
- No healthy volunteers
- Child
Study population: CPPHO [Centro Pediátrico Professor Hosannah de Oliveira (Professor Hosannah de Oliveira Pediatirc Center] C-HUPES [Complexo Hospitalar Professor Edgar Santos (Professor Edgar Santos Hospital Complex)]
Who may be able to join
- children 1 - 18 months of age
- acute diarrhea
- adequately hydrated
- signed informed consent
Who cannot join
- exclusively or predominantly breast-feeding
- bloody diarrhea
- intercurrent illnesses that may affect study parameters
- use of systemic antibiotics during the 72 hours prior to enrollment
- use of anti-diarrheal medications at the time of enrollment
- use of supplement or infant formula with Lactobacillus rhamnosus 10 days prior to enrollment
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Metabolic Unit Fima Lifshitz, Federal University of Bahia School of Medicine
Salvador, Estado de Bahia, 40110-170
About this study
Evaluate the effect of probiotics on stool output in children 1 - 18 months old.
Read the detailed description
Evaluate the effect of probiotics on stool output in children 1 - 18 months old.
- Conditions
- Stool Output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Routine cow milk-based infant formula | |
| Investigational | Cow milk-based infant formula containing probiotics |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startOct 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stool OutputStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hugo Ribeiro, Jr., M.D., Principal investigator, Professor Edgard Santos University Hospital - UFBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081067
- Sponsor's protocol ID
- 3377-1 (6008)
- Status last verified
- Jan 2011
- First submitted
- 3 Mar 2010
- Last updated
- 5 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficiency and Safety of an Infant Formula Containing a Probiotic in Children
- ClinicalTrials.gov ID
- NCT01081067
- Acronym / sponsor ID
- 3377-1 (6008)
- Conditions
- Stool Output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 5 Mar 2010 (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.
Evaluate the effect of probiotics on stool output in children 1 - 18 months old.
Detailed description
Evaluate the effect of probiotics on stool output in children 1 - 18 months old.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Routine cow milk-based infant formula |
| Investigational | – | –Cow milk-based infant formula containing probiotics |
Who may qualify
- Ages
- 1 month to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- CPPHO [Centro Pediátrico Professor Hosannah de Oliveira (Professor Hosannah de Oliveira Pediatirc Center] C-HUPES [Complexo Hospitalar Professor Edgar Santos (Professor Edgar Santos Hospital Complex)]
Key inclusion criteria (4 listed)
- children 1 - 18 months of age
- acute diarrhea
- adequately hydrated
- signed informed consent
Key exclusion criteria (6 listed)
- exclusively or predominantly breast-feeding
- bloody diarrhea
- intercurrent illnesses that may affect study parameters
- use of systemic antibiotics during the 72 hours prior to enrollment
- use of anti-diarrheal medications at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 Jan 2011.
Related trials for Stool Output
Recruiting
Prototyping a Device for Automating Stool and Urine Output Tracking
Waste Output
Recruiting
Testing a Device for Automatically TRacking Urine and STool in an Inpatient HCT Setting (Project TRUST)
Fluid Output
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.
Hugo Ribeiro, Jr., M.D. principal investigator
Professor Edgard Santos University Hospital - UFBA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stool Output, run by Mead Johnson Nutrition at 1 site in Brazil.
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 4 inclusion and 6 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 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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.
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 5 Jan 2011.