Clinical trial NCT03639337: Colonization and Persistence Capacity of a Multi-strain Probiotics in Pediatric Food Allergy to Milk or Egg.
Official title: Use of Probiotics Bifidobacterium Longum, Bifidobacterium Breve and Bifidobacterium Infantis in Treating Pediatric Food Allergy to Milk or Egg.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Hypersensitivity
Probiotic
Keywords: Probiotic
Food allergy
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 33
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Basal stool concentration of Bifidobacterium longum BB536, Bifidobacterium breve M-16V
timeFrame: 2 years
Secondary outcomes:
measure: Stool concentration of Bifidobacterium longum BB536, Bifidobacterium breve M-16V after multi-strain probiotic administration.
timeFrame: 2 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Ospedale Pediatrico Bambino Gesù
Study officials:
affiliation: agiovanni.fiocchi@opbg.net
name: Alessandro Fiocchi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: