AsthmaNCT00826189
Influence of Probiotics on Atopy With Focus on Respiratory Allergic Diseases- Follow-up to 7 Years
An observational study of Asthma and Allergic Rhinitis, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The investigators had conducted an initial double-blind, placebo-controlled clinical trial (NCT00318695) to study the effects of probiotic supplementation from birth to 6 months of age in the incidence of atopic diseases at 2 years old. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Allergic Rhinitis
- How many people
- 253 participants
- Where
- 1 siteSingapore
- Study dates
- May 2009to Jun 2013
- 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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The subjects who have completed NCT00318695 and NCT00365469 studies will be invited to participate in this study.
Who may be able to join
- Subject has completed the both NCT00318695 and NCT00365469 studies.
- Parent(s) / Guardian consent to the subject's participation in the study.
- Subject and the parent(s)/ guardian are willing to comply with the study procedures
Who cannot join
- The parent is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained.
- The parent is unable/ unwilling to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Follow-up Study to 7 Years of a Randomized, Double-blinded, Placebo-controlled Study on the Influence of Probiotics on Atopy With Focus on Respiratory Allergic Diseases
The investigators had conducted an initial double-blind, placebo-controlled clinical trial (NCT00318695) to study the effects of probiotic supplementation from birth to 6 months of age in the incidence of atopic diseases at 2 years old. This is then further investigated up to 5 years of age in a follow-up study NCT00365469 to assess the longer term beneficial effects.
This current study intends to follow-up for another 2 years until 7 years of age as this is critical in the evaluation of respiratory allergies in the form of clinical asthma and allergic rhinitis.
Read the detailed description
This study intends to continue the initial double-blind, placebo-controlled randomized clinical trial (NCT00318695) which involved 253 subjects with a first degree family history of allergic disease. The infants received at least 60ml of commercially available cow's milk based infant formula with or without probiotic supplementation (Bifidobacterium longum [BL999] 1×10*7 colony-forming unit (cfu)/g and Lactobacillus rhamnosus [LPR]2×10*7 cfu/g) daily from the first day of life for the first 6 months. A follow-up study (NCT00365469) up to 5 years of age is currently in process.
This current study plans to continue the follow-up for a further 2 years till the cohort reaches 7 years of age. This study will only involve telephone calls which will be conducted every 3 months to ascertain for symptoms and incidence of respiratory allergic disease.This is critical in the evaluation of asthma and allergic rhinitis which tend to develop later in life and this step-wise, temporal development of respiratory allergies has been described as "Atopic March".
- Conditions
- Asthma, Allergic Rhinitis
- Keywords
- Probiotics, Asthma, Allergic Rhinitis
- Medical subject headings
- Asthma, Rhinitis, Allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma
Measured: 7 years of age
Secondary outcomes (1)
Allergic Rhinitis
Measured: 7 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Principal investigator, Paediatrics, National University Hospital, Singapore
- Investigators
- Lynette Shek, A/Prof, Principal investigator, National University Hospital, SingaporeMarion Aw, A/Prof, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826189
- Sponsor's protocol ID
- SQNU01 (Phase III)
- Status last verified
- Jan 2014
- First submitted
- 21 Jan 2009
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Study to 7 Years of a Randomized, Double-blinded, Placebo-controlled Study on the Influence of Probiotics on Atopy With Focus on Respiratory Allergic Diseases
- ClinicalTrials.gov ID
- NCT00826189
- Acronym / sponsor ID
- SQNU01 (Phase III)
- Conditions
- Asthma, Allergic Rhinitis
- Keywords
- Probiotics, Asthma, Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- May 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 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.
The investigators had conducted an initial double-blind, placebo-controlled clinical trial (NCT00318695) to study the effects of probiotic supplementation from birth to 6 months of age in the incidence of atopic diseases at 2 years old. This is then further investigated up to 5 years of age in a follow-up study NCT00365469 to assess the longer term beneficial effects.
This current study intends to follow-up for another 2 years until 7 years of age as this is critical in the evaluation of respiratory allergies in the form of clinical asthma and allergic rhinitis.
Detailed description
This study intends to continue the initial double-blind, placebo-controlled randomized clinical trial (NCT00318695) which involved 253 subjects with a first degree family history of allergic disease. The infants received at least 60ml of commercially available cow's milk based infant formula with or without probiotic supplementation (Bifidobacterium longum [BL999] 1×10*7 colony-forming unit (cfu)/g and Lactobacillus rhamnosus [LPR]2×10*7 cfu/g) daily from the first day of life for the first 6 months. A follow-up study (NCT00365469) up to 5 years of age is currently in process.
This current study plans to continue the follow-up for a further 2 years till the cohort reaches 7 years of age. This study will only involve telephone calls which will be conducted every 3 months to ascertain for symptoms and incidence of respiratory allergic disease.This is critical in the evaluation of asthma and allergic rhinitis which tend to develop later in life and this step-wise, temporal development of respiratory allergies has been described as "Atopic March".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The subjects who have completed NCT00318695 and NCT00365469 studies will be invited to participate in this study.
Key inclusion criteria (3 listed)
- Subject has completed the both NCT00318695 and NCT00365469 studies.
- Parent(s) / Guardian consent to the subject's participation in the study.
- Subject and the parent(s)/ guardian are willing to comply with the study procedures
Key exclusion criteria (2 listed)
- The parent is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained.
- The parent is unable/ unwilling to comply with study procedures
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
Asthma
Time frame: 7 years of age
1 secondary outcome
Allergic Rhinitis
Time frame: 7 years of age
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 2014.
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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.
Lynette Shek, A/Prof principal investigator
National University Hospital, Singapore
Marion Aw, A/Prof principal investigator
National University Hospital, Singapore
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 Asthma and Allergic Rhinitis, run by National University Hospital, Singapore at 1 site in Singapore.
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 3 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 9 Jan 2014. 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 Singapore. 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?
Asthma (time frame: 7 years of age). 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 2014.