Microbiota as Potential Target for Food Allergy | NCT02087930

Studies
Microbiota as Potential Target for Food Allergy

NCT02087930

Sponsor

Federico II University

Status

Unknown status

Last Update Posted

May 29, 2018Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Cow Milk Allergy

Interventions

Not provided

Countries

Italy

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

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

May 2020Estimated

Completion Date

Sep 2020Estimated

First Submitted Date

Mar 10, 2014

First Submission Date that Met QC Criteria

Mar 13, 2014

First Posted Date

Mar 14, 2014Estimated

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

May 24, 2018

Last Update Posted Date

May 29, 2018Actual

Description Module

Brief Summary

Food allergy (FA) derives from a dysregulation of oral tolerance mechanisms. Studies suggest a crucial role for enteric microflora in oral tolerance development. An altered composition of intestinal microflora results in an unbalanced local and systemic immune response to food allergens. There are qualitative and quantitative differences in gut microbiota composition in children with food allergy. These findings support the concept that specific beneficial bacteria from human intestinal microflora, designated probiotics, could restore intestinal microflora homeostasis and prevent or treat FA.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cow milk allergy children		Children affected by Immunoglobulin E medited cow milk allergy
healthy control		healthy infants

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composition and function gut microbiota in children with cow milk allergy and healthy children		Change from baseline at 6 and 12 months

Secondary Outcomes

Measure	Description	Time Frame
Composition and function gut microbiota comparing cow milk allergy Italian and cow milk allergy children of other countries		Change from baseline at 6 and 12 months
Composition and function gut microbiota comparing healthy Italian and healthy children of other countries

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children with cow's milk allergy
age 6-12 months

Exclusion Criteria:

concomitant chronic systemic diseases
congenital cardiac defects
active tuberculosis
autoimmune diseases
immunodeficiency
chronic inflammatory bowel diseases
celiac disease, cystic fibrosis
metabolic diseases
malignancy
chronic pulmonary diseases
malformations of the gastrointestinal tract
suspected eosinophilic esophagitis or eosinophilic enterocolitis
suspected food-protein-induced enterocolitis syndrome.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

12 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Naples Federico II	Recruiting	Naples		80131	Italy

Condition Browse Module

MeSH Terms

ID	Term
D016269	Milk Hypersensitivity

Ancestor Terms

ID	Term
D005512	Food Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided