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

NCT ID: NCT03639337

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-08-31

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.

Conditions

Food Hypersensitivity; Probiotic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Multi-strain probiotic

Intervention Type: 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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Controls

Healthy controls ages between 10 and 14 months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Months
• Maximum Eligible Age: 14 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bambino Gesù Hospital and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Alessandro Giovanni Fiocchi

Director Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alessandro Fiocchi, M.D.

Role: PRINCIPAL_INVESTIGATOR

agiovanni.fiocchi@opbg.net

Locations

Ospedale Pediatrico Bambino Gesù

Roma, , Italy

Countries

Italy

Other Identifiers

787_OPBG_2014

Identifier Type: -

Identifier Source: org_study_id