Biodiversity Intervention and Atopic Sensitization | NCT03872219

Studies
Biodiversity Intervention and Atopic Sensitization

NCT03872219

Sponsor

University of Helsinki

Status

Unknown status

Last Update Posted

Mar 13, 2019Actual

Enrollment

350Estimated

Phase

Not Applicable

Conditions

Atopy
Allergy
Allergic Rhinitis
Allergic Sensitisation

Interventions

Nature-based materials

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2019Estimated

Primary Completion Date

Aug 31, 2023Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Mar 11, 2019

First Submission Date that Met QC Criteria

Mar 11, 2019

First Posted Date

Mar 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2019

Last Update Posted Date

Mar 13, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aki Sinkkonen, University Researcher, University of HelsinkiPrincipal Investigator

Lead Sponsor

University of HelsinkiOTHER

Collaborators

Name	Class
Tampere University	OTHER
Pirkanmaa Hospital District (Pirkanmaan sairaanhoitopiiri)	UNKNOWN
Business Finland (National Innovation Agency)	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Children will receive biodiversity intervention or placebo. The proof of concept trial is double blind. Intervention will start at the age of 2 months and last 10 months. Children will be randomized to arms. IgE sensitization is the primary outcome.

Detailed Description

Newborns will start to be exposed to biodiversity intervention or placebo at the age of two months. The proof of concept trial will be double blind. Intervention will start at the age of 2 months and it will end when children become 12 months old. Children will be randomized to the two arms. IgE sensitization is the primary outcome at the age of two and three years.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	The children will receive and they are exposed daily to harmless materials that look and feel like the biodiversity intervention materials.	Combination Product: Nature-based materials
intervention arm	Experimental	The children will receive and they are exposed daily to materials of high microbiological biodiversity.	Combination Product: Nature-based materials

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nature-based materials	Combination Product	In the intervention arm, theycontain inactive and slowly-growing environmental bacteria and other microbiota. In the placebo arm, they do not contain the microbiota.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
IgE sensitization	IgE sentitization is expected to be lower in the intervention arm than in the placebo arm.	2-3 years

Secondary Outcomes

Measure	Description	Time Frame
Allergic symptoms	All possible allergic symptomes, including atopy, will be estimated	2-3 years

Other Outcomes

Measure	Description	Time Frame
IL-10: IL-17 ratio		2-3 years
TGF-beta level		2-3 years
IL-10 levels

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

both parents have atopy
newborn

Exclusion Criteria:

severe disease, particularly immune system deficiency or down syndrome or cancer
medication affecting immune system
birth before week 35 in pregnancy
being a twin
only one of the parents have atopy
none of the parents have atopy
children have passed the age of two months
immune system disorder such as rheumatoid disease, colitis ulcerosa, Crohn disease, diabetes or genetic risk to type 1 diabetes
no participation in national vaccination programme

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Month

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aki Sinkkonen	Contact	358 2941 20315		aki.sinkkonen@helsinki.fi
Riikka Puhakka	Contact	358 50 3199363		riikka.puhakka@helsinki.fi

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

We will share it according to Finnish legislation and ethical committee permission. The permission restrict sharing tightly.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006967	Hypersensitivity
D065631	Rhinitis, Allergic

Ancestor Terms

ID	Term
D007154	Immune System Diseases
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided