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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Ruggiero Francavilla, University of Bari.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01699191
First Posted: October 3, 2012
Last Update Posted: October 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ruggiero Francavilla, University of Bari
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Ruggiero Francavilla, University of Bari:

Primary Outcome Measures:
  • Treatment of abdominal pain in celiac patients [ Time Frame: 14 weeks ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ruggiero Francavilla, Consultant in Gastroenterology, University of Bari
ClinicalTrials.gov Identifier: NCT01699191     History of Changes
Other Study ID Numbers: ProCeDo
First Submitted: October 1, 2012
First Posted: October 3, 2012
Last Update Posted: October 3, 2012
Last Verified: October 2012

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

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