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

NCT03857360 | Completed

• 1 other identifier: CD-PENTABIOCEL
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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

Celiac Disease

Keywords

Gluten; Probiotic; Microbiota; Dysbiosis

Outcome Measures

Primary Outcomes (1)

• Assessment of recovery time of clinical features

  After three months of probiotic treatment patients will be compared with their clinical symptoms evaluating score based Celiac symptom Index (CSI) developed by Leffler DA et al.

  3 months

Secondary Outcomes (1)

• Differences between two treatment groups related to all the evaluated parameters

  3 & 6 months

Study Arms (2)

Pentabiocel

ACTIVE COMPARATOR

Oral administration of one sachet of Pentabiocel for 12 consecutive weeks.

Dietary Supplement: Pentabiocel

Placebo

PLACEBO COMPARATOR

Oral administration of one sachet of Placebo per day for 12 consecutive weeks.

Dietary Supplement: Placebo

Interventions

Pentabiocel DIETARY_SUPPLEMENT

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.

Pentabiocel

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children / adolescents aged between 2 and 16 recruited at the time of diagnosis of celiac disease.
• The diagnosis of celiac disease will be performed according to the ESPGHAN 2012 Guidelines.

You may not qualify if:

• Patients with autoimmune comorbidity (eg type 1 diabetes) or other associated chronic diseases
• Associated serum IgA selective deficiency
• Poor adherence to gluten free diet at the 6-month control, measured by a score\> 10 at the Wessels questionnaire.
• Adherence to the intervention protocol \<85%.
• Antibiotic therapy performed during the 7 days preceding T0 and / or T6.
• Antibiotic therapy during the 3 months of probiotic / placebo treatment.

Sponsors & Collaborators

• Università Politecnica delle Marche: lead
• Noos S.r.l.: collaborator

Study Sites (1)

Department of Pediatrics, via Corridoni 11

Ancona, 60123, Italy

Location

Related Publications (2)

• Lionetti E, Castellaneta S, Francavilla R, Pulvirenti A, Tonutti E, Amarri S, Barbato M, Barbera C, Barera G, Bellantoni A, Castellano E, Guariso G, Limongelli MG, Pellegrino S, Polloni C, Ughi C, Zuin G, Fasano A, Catassi C; SIGENP (Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition) Working Group on Weaning and CD Risk. Introduction of gluten, HLA status, and the risk of celiac disease in children. N Engl J Med. 2014 Oct 2;371(14):1295-303. doi: 10.1056/NEJMoa1400697.

  PMID: 25271602 BACKGROUND

• Fasano A, Catassi C. Clinical practice. Celiac disease. N Engl J Med. 2012 Dec 20;367(25):2419-26. doi: 10.1056/NEJMcp1113994. No abstract available.

  PMID: 23252527 RESULT

MeSH Terms

Conditions

Celiac Disease; Dysbiosis

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlo Catassi, MPH

  Univeristà Politecnica delle Marche, Ancona, Italy

  PRINCIPAL INVESTIGATOR

• Elena Lionett, PhD

  Univeristà Politecnica delle Marche, Ancona, Italy

  PRINCIPAL INVESTIGATOR

• Basilio Malamisura

  Cava de' Tirreni - Ospedale di cava De' tirreni, UO di Pediatria, Salerno, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Head, Department of Pediatrics

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 28, 2019
• Study Start: March 15, 2019
• Primary Completion: August 15, 2021
• Study Completion: August 15, 2021
• Last Updated: October 4, 2021

Record last verified: 2021-10

Locations

IT (1)