NCT01699191

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

October 3, 2012

Status Verified

October 1, 2012

Enrollment Period

1 year

First QC Date

October 1, 2012

Last Update Submit

October 2, 2012

Conditions

IBS in Celiac Desease

Keywords

Irritable Bowel SyndromeCeliac DeseaseProbioticLactobacillus plantarumBifidobacterium breveLactobacillus caseiBifidobacterium animalis

Outcome Measures

Primary Outcomes (1)

  • Treatment of abdominal pain in celiac patients

    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.

    14 weeks

Study Arms (2)

Probiotic Mixture

ACTIVE COMPARATOR

Probiotic mixture

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

ProbioticDIETARY_SUPPLEMENT
Probiotic Mixture
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Pediatrica

Bari, Apulia, 70125, Italy

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ruggiero Francavilla

    DEPARTMENT OF BIOMEDICINA ETA' EVOLUTIVA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruggiero Francavilla

CONTACT

0805592963rfrancavilla@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in Gastroenterology

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 3, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

January 1, 2014

Last Updated

October 3, 2012

Record last verified: 2012-10

Locations

IT(1)