Gastrointestinal ProblemsNCT01177605
Assessment of Efficacy and Tolerance of a Follow-On Milk Containing a Mixture of Prebiotics Fed to Young Children in Salvador, Bahia, Brazil
A study testing Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics in people with Gastrointestinal Problems, run by Mead Johnson Nutrition at 1 site in Brazil.
Trial summary
This clinical study will evaluate the effect on incidence of diarrhea, respiratory illness, stool patterns and growth of two cow's milk-based beverages for children. Read more about this study
- Who is it for?
- Ages 9 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Problems
- What is being tested?
- Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteBrazil
- Study dates
- Sep 2006to Mar 2007
- 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 9 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child 9 - 48 months of age
- Child has consumed a cow follow-on milk during the 48 hours prior to enrollment
- Child's weight for age is within the 10th -90th percentiles
- Child's length for age is within 10th - 90th percentiles
- Signed informed consent obtained
Who cannot join
- Children who are receiving predominantly breast-milk
- Serious concurrent illness
- Children with diarrhea or acute respiratory infection during the 48 hours prior to randomization
- Children with a history of underlying metabolic or chronic disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the participant.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Bahia School of Medicine
Salvador, Estado de Bahia, 41830-380
About this study
This clinical study will evaluate the effect on incidence of diarrhea, respiratory illness, stool patterns and growth of two cow's milk-based beverages for children.
- Conditions
- Gastrointestinal Problems
- Being tested
- Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebioticsOther
Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics
| Study group | Role | What they receive |
|---|---|---|
| Vanilla flavored milk-based beverage containing no prebiotics | Placebo comparator | Vanilla flavored milk-based beverage containing no prebiotics Receives: Other: Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics |
| Vanilla flavored milk-based beverage containing prebiotics | Experimental | Vanilla flavored milk-based beverage containing prebiotics Receives: Other: Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startSep 2006
- Primary completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ProblemsStudies 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
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177605
- Sponsor's protocol ID
- 3376-1 (8575)
- Status last verified
- Aug 2011
- First submitted
- 3 Aug 2010
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy and Tolerance of a Follow-On Milk Containing a Mixture of Prebiotics Fed to Young Children in Salvador, Bahia, Brazil
- ClinicalTrials.gov ID
- NCT01177605
- Acronym / sponsor ID
- 3376-1 (8575)
- Conditions
- Gastrointestinal Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Mar 2007 (actual)
- First posted
- 9 Aug 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.
This clinical study will evaluate the effect on incidence of diarrhea, respiratory illness, stool patterns and growth of two cow's milk-based beverages for children.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vanilla flavored milk-based beverage containing no prebiotics | Placebo comparator | Other: Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebioticsVanilla flavored milk-based beverage containing no prebiotics |
| Vanilla flavored milk-based beverage containing prebiotics | Experimental | Other: Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebioticsVanilla flavored milk-based beverage containing prebiotics |
Who may qualify
- Ages
- 9 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Child 9 - 48 months of age
- Child has consumed a cow follow-on milk during the 48 hours prior to enrollment
- Child's weight for age is within the 10th -90th percentiles
- Child's length for age is within 10th - 90th percentiles
- Signed informed consent obtained
Key exclusion criteria (4 listed)
- Children who are receiving predominantly breast-milk
- Serious concurrent illness
- Children with diarrhea or acute respiratory infection during the 48 hours prior to randomization
- Children with a history of underlying metabolic or chronic disease or congenital malformation which, in the opinion of the Investigator, is likely to interfere with the normal growth and development or the evaluation of the participant.
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 |
|---|---|---|
| Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebioticsNutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics | Other | Vanilla flavored milk-based beverage containing no prebiotics, Vanilla flavored milk-based beverage containing prebiotics |
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 2 Sep 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics in people with Gastrointestinal Problems, 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 5 inclusion and 4 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 2 Sep 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. Some participants in this study may receive a placebo. 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 2 Sep 2011.