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Effectiveness of PENTABIOCEL in Clinical and Laboratory Recovery of Children With Celiac Disease

NCT03857360 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2021-10-04

No results posted yet for this study

Summary

Celiac disease (CD) is an inflammatory condition of the small intestine. Environmental and genetic factors are involved in the development of CD. Apart from environmental and genetic factors other factors may also be involved, such as alteration in intestinal microbiota. Probiotic supplementation has been shown to be able to determine the intestinal healing. Recently the use of a mixture of some specific bacterial strains has shown its effectiveness. In this study effectiveness of a probiotic "Pentabiocel" which is a mixture of five different bacterial strains will be evaluated in CD affected children (already on a gluten-free diet) through a double-blind randomised placebo control trial.

Conditions

Interventions

DIETARY_SUPPLEMENT

Pentabiocel

Pentabiocel is the trade name of the product containing the probiotic mixture of: Lactobacillus paracasei LMG P-17504, Lactobacillus plantarum CECT 4528, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve BL10 LMG P-17500 and Bifidobacterium animalis subsp lactis Bi1 LMG P -17,502.

DIETARY_SUPPLEMENT

Placebo

Placebo is composed of maltodextrin which is easily digestible, being absorbed as rapidly as glucose. Maltodextrin listed by the U.S. Food and Drug Administration (FDA) as a safe food additive.

Sponsors & Collaborators

  • Noos S.r.l.

    collaborator INDUSTRY

  • Università Politecnica delle Marche

    lead OTHER

Principal Investigators

  • Carlo Catassi, MPH · Univeristà Politecnica delle Marche, Ancona, Italy

  • Elena Lionett, PhD · Univeristà Politecnica delle Marche, Ancona, Italy

  • Basilio Malamisura · Cava de' Tirreni - Ospedale di cava De' tirreni, UO di Pediatria, Salerno, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-15
Primary Completion
2021-08-15
Completion
2021-08-15

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03857360 on ClinicalTrials.gov