Atopic DermatitisNCT02077088
Effect of Galactooligosaccharides on Incidence of Atopic Manifestations in Infants
A study testing galactooligosaccharide in people with Atopic Dermatitis, run by Humana Co.Ltd. at 1 site in Czechia.
Trial summary
Addition of prebiotic galactooligosaccharides to hypoallergenic starter formula would lead to decreased allergic (atopic) symptoms in nonbreastfed infants with a positive history of allergy in family Read more about this study
- Who is it for?
- Ages 6 to 8 weeks
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- galactooligosaccharide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- Jun 2009to Apr 2013
- 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 6 to 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- nonbreastfed eutrophic infants of corresponding gestational age
- presence of a positive family allergic anamnesis in parents or siblings (atopic eczema, allergic rhinitis or bronchial asthma)
Who cannot join
- children with serious disease,
- breastfed children
- children fed another formula then the ones used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double Blind, Randomised Study on the Effect of Prebiotics on Incidence of Atopic Manifestations in Infants
Addition of prebiotic galactooligosaccharides to hypoallergenic starter formula would lead to decreased allergic (atopic) symptoms in nonbreastfed infants with a positive history of allergy in family
- Conditions
- Atopic Dermatitis
- Being tested
- galactooligosaccharide
- Keywords
- interventional, doubleblind, randomised, pediatric, prebiotic, atopic, dermatitis, infant
- Medical subject headings
- Dermatitis, Atopic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
galactooligosaccharideOther
Also called GOS, prebiotics
addition of food grade GRAS (Generally Regarded As Safe) galactooligosaccharides
| Study group | Role | What they receive |
|---|---|---|
| Galactooligosaccharides | Experimental | addition of 0,5g galactooligosaccharides to HA (hypoallergenic) starter formula Receives: Other: galactooligosaccharide |
| Only HA formula | No intervention | only standard HA starter formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD (SCORing Atopic Dermatitis score) assessment of atopy
objective evaluation of atopic symptoms
Measured: at 6 months of age
Secondary outcomes (1)
anthropometric parameters (height, weight)
Measured: at 6 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startJun 2009
- Primary completionNov 2012
- Study completionApr 2013
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 Atopic DermatitisStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humana Co.Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vitkovice Hospital
- Responsible party
- Sponsor
- Investigators
- Jan Bozensky, MD, Principal investigator, Vitkovice Hospital, Ostrava, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077088
- Sponsor's protocol ID
- 1.090
- Status last verified
- Feb 2014
- First submitted
- 2 Jan 2014
- Last updated
- 4 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bozensky J, Hill M, Zelenka R, Skyba T. Prebiotics Do Not Influence the Severity of Atopic Dermatitis in Infants: A Randomised Controlled Trial. PLoS One. 2015 Nov 16;10(11):e0142897. doi: 10.1371/journal.pone.0142897. eCollection 2015.
PubMed 26571488
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind, Randomised Study on the Effect of Prebiotics on Incidence of Atopic Manifestations in Infants
- ClinicalTrials.gov ID
- NCT02077088
- Acronym / sponsor ID
- 1.090
- Conditions
- Atopic Dermatitis
- Keywords
- interventional, doubleblind, randomised, pediatric, prebiotic, atopic, dermatitis, infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Humana Co.Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Vitkovice Hospital
- Study start
- Jun 2009
- Primary completion
- Nov 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Mar 2014 (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.
Addition of prebiotic galactooligosaccharides to hypoallergenic starter formula would lead to decreased allergic (atopic) symptoms in nonbreastfed infants with a positive history of allergy in family
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galactooligosaccharides | Experimental | Other: galactooligosaccharideaddition of 0,5g galactooligosaccharides to HA (hypoallergenic) starter formula |
| Only HA formula | No intervention | –only standard HA starter formula |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- nonbreastfed eutrophic infants of corresponding gestational age
- presence of a positive family allergic anamnesis in parents or siblings (atopic eczema, allergic rhinitis or bronchial asthma)
Key exclusion criteria (3 listed)
- children with serious disease,
- breastfed children
- children fed another formula then the ones used
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 |
|---|---|---|
| galactooligosaccharideAlso: GOS, prebioticsaddition of food grade GRAS (Generally Regarded As Safe) galactooligosaccharides | Other | Galactooligosaccharides |
Primary outcome
SCORAD (SCORing Atopic Dermatitis score) assessment of atopy
Time frame: at 6 months of age
objective evaluation of atopic symptoms
1 secondary outcome
anthropometric parameters (height, weight)
Time frame: at 6 months 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 4 Mar 2014.
- Derived from this study: PubMed 26571488Bozensky J, Hill M, Zelenka R, Skyba T. Prebiotics Do Not Influence the Severity of Atopic Dermatitis in Infants: A Randomised Controlled Trial. PLoS One. 2015 Nov 16;10(11):e0142897. doi: 10.1371/journal.pone.0142897. eCollection 2015.
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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.
Jan Bozensky, MD principal investigator
Vitkovice Hospital, Ostrava, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing galactooligosaccharide in people with Atopic Dermatitis, run by Humana Co.Ltd. at 1 site in Czechia.
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 4 Mar 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 Czechia. 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?
SCORAD (SCORing Atopic Dermatitis score) assessment of atopy (time frame: at 6 months of age). 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 NCT02077088, 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 4 Mar 2014.