Colonization and Persistence Capacity of a Multi-strain Probiotics in Pediatric Food Allergy to Milk or Egg.

NCT03639337 | Completed DMC

• 1 other identifier: 787_OPBG_2014
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the addition of three probiotics (Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis) in the treatment of pediatric food allergic children to milk or egg. The allergic participants will receive the probiotics, while other two populations age and sex matched of not confirmed allergic and healthy children will not receive probiotics.

Conditions

Food Hypersensitivity; Probiotic

Keywords

Probiotic; Food allergy

Outcome Measures

Primary Outcomes (1)

• Basal stool concentration of Bifidobacterium longum BB536, Bifidobacterium breve M-16V

  It will be indicated number of cells per ul of stool.

  2 years

Secondary Outcomes (1)

• Stool concentration of Bifidobacterium longum BB536, Bifidobacterium breve M-16V after multi-strain probiotic administration.

  2 years

Study Arms (3)

Allergic Children

EXPERIMENTAL

Allergic children to milk or egg, aged between 10 and 14 months, confirmed by double-blind oral provocation test against placebo. Intervention: 30 days of administration of multi-strain probiotics containing 3.5 x 109 UFC of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63

Dietary Supplement: Multi-strain probiotic

Not confirmed Allergic Children

NO INTERVENTION

Sensible children to milk or egg, aged between 10 and 14 months, not confirmed by double-blind oral provocation test against placebo.

Controls

NO INTERVENTION

Healthy controls ages between 10 and 14 months

Interventions

Multi-strain probiotic DIETARY_SUPPLEMENT

30 days of administration of multi-strain probiotics containing 3.5 x 109 UFC of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63

Allergic Children

Eligibility Criteria

• Age: 10 Months - 14 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- Age between 10 and 14 months

You may not qualify if:

• gastrointestinal disease in progress or appearance in the last 30 days
• metabolic diseases
• antibiotic treatment in the 2 weeks prior to the start of the study;
• intake of probiotic, fermented milk or other functional foods in the two weeks preceding the start of the study.

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

Study Sites (1)

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Alessandro Fiocchi, M.D.

  agiovanni.fiocchi@opbg.net

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Clinical Research

Study Record Dates

• First Submitted: August 17, 2018
• First Posted: August 21, 2018
• Study Start: January 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

IT (1)