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

Not Applicable

Completed

• Conditions: Food Hypersensitivity; Probiotic
• Interventions: Dietary Supplement: Multi-strain probiotic

• Registration Number: NCT03639337
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

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.

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 Timeline

• Study Start: 2015-01
• Status Verified: 2018-08
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-21
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allergic Children	Multi-strain probiotic	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

Primary Outcome Measures

Name	Time	Method
Basal stool concentration of Bifidobacterium longum BB536, Bifidobacterium breve M-16V	2 years	It will be indicated number of cells per ul of stool.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ospedale Pediatrico Bambino Gesù; 🇮🇹 Roma, Italy