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

Use of Probiotics Bifidobacterium Longum, Bifidobacterium Breve and Bifidobacterium Infantis in Treating Pediatric Food Allergy to Milk or Egg.

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.

Study Overview

• Status: Completed
• Conditions: Food Hypersensitivity; Probiotic
• Intervention / Treatment: Dietary supplement: Multi-strain probiotic

Detailed Description

This study evaluates the colonization capacity of three probiotics (Bifidobacterium longum, Bifidobacterium breve and Bifidobacterium infantis) in milk and/or egg allergic children.

It is expected the recruitment of about 20 egg and/or milk allergic patients aged between 10 and 14 months old confirmed with double-blind oral tolerance test against placebo (Group 1).

Furthermore, about 10 patients sensible to milk or egg but not confirmed with double-blind oral tolerance test against placebo (Group 2) will be recruited and about 10 healthy individuals (Group 3).

For all 40 patients:

1. Baseline presence of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63 will be evaluated;

   Only for Group 1 children it will be also evaluate:

2. The presence of the same strains during 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 and after 60 days from the suspension of the administration.

Quantification of B. breve, B. longum subsp. longum and B. longum subsp. infantis in faecal samples was carried out by qRT-PCR using the Light Cycler 480 platform (Roche Diagnostics, Mannheim, Germany). The assays were performed with a 20 µl PCR amplification mixture containing: 10 µl LightCycler 480 Probe Master mix (Roche Diagnostics), 2 µl primers and probes (optimized concentrations, 0.5 µM and 0.1 µM, respectively), 3 µl molecular-grade H2O and 5 µl DNA template. Each sample was tested in duplicate to ensure data reproducibility. The RT-PCR temperature profile consisted of an initial denaturation at 95°C for 10 min, 45 amplification cycles at 95°C for 10 sec, 60°C for 30 sec and 72°C for 1 sec followed by a final cooling step at 40°C for 30 sec. Absolute quantification was performed using the "second derivative maximum method"

Statistical analyses: Wilcoxon signed-rank test was used to compare probiotic species concentrations during the time-course.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • Ospedale Pediatrico Bambino Gesù

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Age between 10 and 14 months

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Allergic Children; 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; 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
No Intervention: Not confirmed Allergic Children; Sensible children to milk or egg, aged between 10 and 14 months, not confirmed by double-blind oral provocation test against placebo.
No Intervention: Controls; Healthy controls ages between 10 and 14 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool concentration of Bifidobacterium longum BB536, Bifidobacterium breve M-16V after multi-strain probiotic administration.	It will be indicated number of cells per ul of stool.	2 years

Collaborators and Investigators

• Sponsor: Bambino Gesù Hospital and Research Institute
• Investigators: Principal Investigator: Alessandro Fiocchi, M.D., agiovanni.fiocchi@opbg.net

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Probiotic; Food allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 787_OPBG_2014