DiarrhoeaPhase 3NCT00823056
The Effect of Probiotics on Infections in Toddlers
A Phase 3 study testing probiotics in people with Diarrhoea and Respiratory Diseases, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children. The investigators hypothesis is: if young children in the age of 6 month to 15 mdr. Read more about this study
- Who is it for?
- Ages 6 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Diarrhoea, Respiratory Diseases
- What is being tested?
- probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 454 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Dec 2011
- Phase
- Phase 3
- 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 6 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy Children born in University Hospital Holbaek,Hospital North,Region Zealand, Denmark in the period of Jan. 2009 to Oct. 2010
- Gestational age > 36. weeks
Who cannot join
- Chronical heart or lung conditions
- Short Bowel Syndrome
- CVC (Central Venous Catheter)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Paediatr. Depart., University Hospital Holbaek, University of Copenhagen
Holbæk, Region Sjælland, 4300
About this study
Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children.
The investigators hypothesis is: if young children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.
Read the detailed description
Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children.
Our hypothesis is: if young healthy children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics( BB12 and TH4) in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.
- Conditions
- Diarrhoea, Respiratory Diseases
- Being tested
- probiotics
- Keywords
- Probiotics, Infections, Children
- Medical subject headings
- Diarrhea, Respiratory Tract Diseases, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsDietary supplement
placebo
probioticsDietary supplement
0,53 ml MCT oil containing BB12 and TH4 in daily dosage in 9 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Dietary Supplement: probiotics |
| 2 | Active comparator | Not described Receives: Dietary Supplement: probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
fewer infections
Measured: 9 months
Secondary outcomes (1)
growth
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrhoeaStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 454 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Holbaek Sygehus, Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK, Novonesis, Ferrosan AS
- Investigators
- Mette L. Gyhrs, MD., Principal investigator, ph.d student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823056
- Sponsor's protocol ID
- Version 2
- Status last verified
- Apr 2012
- First submitted
- 14 Jan 2009
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Nielsen AC, Gyhrs ML, Nielsen LP, Pedersen C, Bottiger B. Gastroenteritis and the novel picornaviruses aichi virus, cosavirus, saffold virus, and salivirus in young children. J Clin Virol. 2013 Jul;57(3):239-42. doi: 10.1016/j.jcv.2013.03.015. Epub 2013 Apr 19.
PubMed 23602437
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on Infections in Toddlers
- ClinicalTrials.gov ID
- NCT00823056
- Acronym / sponsor ID
- Version 2
- Conditions
- Diarrhoea, Respiratory Diseases
- Keywords
- Probiotics, Infections, Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 454 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Holbaek Sygehus, Dept. of Microbiology, Slagelse University Hospital, Region Zealand,DK, Novonesis, Ferrosan AS
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Jan 2009 (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.
Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children.
The investigators hypothesis is: if young children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.
Detailed description
Probiotics has been known as a dietary supplement for a long period. Recent clinical trials indicate that probiotics might have an effect in preventing common infection diseases in children.
Our hypothesis is: if young healthy children in the age of 6 month to 15 mdr. has a daily intake of a suspension containing probiotics( BB12 and TH4) in a period of 9 months, the incidence of diarrhoea and respiratory diseases can be reduced.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: probiotics |
| 2 | Active comparator | Dietary Supplement: probiotics |
Who may qualify
- Ages
- 6 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy Children born in University Hospital Holbaek,Hospital North,Region Zealand, Denmark in the period of Jan. 2009 to Oct. 2010
- Gestational age > 36. weeks
Key exclusion criteria (3 listed)
- Chronical heart or lung conditions
- Short Bowel Syndrome
- CVC (Central Venous Catheter)
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 |
|---|---|---|
| probioticsplacebo | Dietary supplement | 1 |
| probiotics0,53 ml MCT oil containing BB12 and TH4 in daily dosage in 9 months | Dietary supplement | 2 |
Primary outcome
fewer infections
Time frame: 9 months
1 secondary outcome
growth
Time frame: 9 months
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 24 Apr 2012.
- Derived from this study: PubMed 23602437Nielsen AC, Gyhrs ML, Nielsen LP, Pedersen C, Bottiger B. Gastroenteritis and the novel picornaviruses aichi virus, cosavirus, saffold virus, and salivirus in young children. J Clin Virol. 2013 Jul;57(3):239-42. doi: 10.1016/j.jcv.2013.03.015. Epub 2013 Apr 19.
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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.
Mette L. Gyhrs, MD. principal investigator
ph.d student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing probiotics in people with Diarrhoea and Respiratory Diseases, run by Zealand University Hospital at 1 site in Denmark.
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 3 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 24 Apr 2012. 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 Denmark. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
fewer infections (time frame: 9 months). 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 NCT00823056, which also lists 1 linked publication.
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 24 Apr 2012.