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Probiotics for the Treatment of Irritable Bowel Syndrome in Celiac Patients (ProCel)

This study is not yet open for participant recruitment.
Verified October 2012 by University of Bari
Sponsor:
Information provided by (Responsible Party):
Ruggiero Francavilla, University of Bari
ClinicalTrials.gov Identifier:
NCT01699191
First received: October 1, 2012
Last updated: October 2, 2012
Last verified: October 2012
History of Changes
  Purpose

Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria and maintaining the integrity of the gut mucosal barrier. The beneficial effects of probiotics have been previously studied in adult patients with IBS. Clinical studies show that patients meeting the criteria for diagnosis for IBS have greater probability for being affected by celiac desease if compared to controls without IBS. Since one of the causes attributed to the onset of IBS is the modified flora gut, it is interesting to determine the beneficial effects that probiotics may have on gastrointestinal symptoms in celiac disease patients. The goal of the present study is to determine whether oral administration of a probiotic mixture of Lactobacillus plantarum 14D-CECT 4528, Lactobacillus casei, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve Bl10 LMG P-17500 and Bifidobacterium animalis under randomized, double-blind, placebo-controlled conditions would improve symptoms of adult celiac patients with IBS.


Condition Intervention
IBS in Celiac Desease
 Dietary Supplement: Probiotic
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

Further study details as provided by University of Bari:

Primary Outcome Measures:
  • Treatment of abdominal pain in celiac patients [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

    Primary outcome will be the incidence in IBS in celiac patients receiving probiotics mixture as compared to those receiving placebo.

    IBS will be diagnosed and categorised according to ROME III criteria.



Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Probiotic Mixture
Probiotic mixture
 Dietary Supplement: Probiotic
Placebo Comparator: Placebo
Placebo
 Dietary Supplement: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Celiac patients aged between 18 and 65 years
  • Diagnosis of IBS on the basis of Rome III criteria
  • GFD
  • Informed consent

Exclusion Criteria:

  • Previous sigmoidoscopy or colonoscopy in the past 5 years
  • Known concomitant organic diseases, including inflammatory bowel disease and other systemic diseases significant
  • Treatment with antispasmodic drugs within the previous month
  • Are pregnant
  • Immunodeficiency
  • Previous abdominal surgery, with the exception of the hernia repair or appendectomy
  • Treatment with antibiotics within the previous month
  • Treatment with probiotics and / or prebiotics within the previous month
  • Participation in other clinical trials
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699191

Contacts
Contact: Ruggiero Francavilla 0805592963 rfrancavilla@gmail.com

Locations
Italy
Clinica Pediatrica Active, not recruiting
Bari, Puglia, Italy, 70125
Sponsors and Collaborators
University of Bari
Investigators
Principal Investigator: Ruggiero Francavilla DEPARTMENT OF BIOMEDICINA ETA' EVOLUTIVA
  More Information

No publications provided

Responsible Party: Ruggiero Francavilla, Consultant in Gastroenterology, University of Bari
ClinicalTrials.gov Identifier: NCT01699191     History of Changes
Other Study ID Numbers: ProCeDo
Study First Received: October 1, 2012
Last Updated: October 2, 2012
Health Authority: Italy: CE IRCCS De Bellis

Keywords provided by University of Bari:
Irritable Bowel Syndrome
Celiac Desease
Probiotic
Lactobacillus plantarum
 Bifidobacterium breve
Lactobacillus casei
Bifidobacterium animalis

Additional relevant MeSH terms:
Celiac Disease
Irritable Bowel Syndrome
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Metabolic Diseases
Colonic Diseases, Functional
Colonic Diseases

ClinicalTrials.gov processed this record on May 21, 2013