NCT02087930

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

May 29, 2018

Status Verified

May 1, 2018

Enrollment Period

7.2 years

First QC Date

March 10, 2014

Last Update Submit

May 24, 2018

Conditions

Cow Milk Allergy

Outcome Measures

Primary Outcomes (1)

  • Composition and function gut microbiota in children with cow milk allergy and healthy children

    Change from baseline at 6 and 12 months

Secondary Outcomes (2)

  • 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

    Change from baseline at 6 and 12 months

Study Arms (2)

Cow milk allergy children

Children affected by Immunoglobulin E medited cow milk allergy

healthy control

healthy infants

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 14, 2014

Study Start

March 1, 2013

Primary Completion

May 1, 2020

Study Completion

September 1, 2020

Last Updated

May 29, 2018

Record last verified: 2018-05

Locations

IT(1)