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The Effect of a Multispecies Probiotic on Hypersensitivity in Irritable Bowel Syndrome (IBS) Patients

Primary Purpose

Irritable Bowel Syndrome, Hypersensitivity

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
multispecies probiotic (Ecologic 801)
Placebo
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Hypersensitivity, Probiotics, Multispecies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of IBS according to the Rome III criteria
  • Increased visceral perception according to barostat measurements, defined as a pain tolerance threshold at smaller than or equal to 23 mmHg
  • Age between 18 and 65 years
  • BMI between 18.5 and 30 kg/m2

Exclusion Criteria:

  • Known gastro-intestinal diseases
  • Major abdominal surgery
  • Previous radiotherapy, chemotherapy
  • Clinical significant systemic diseases
  • Critically ill patients or patients suffering from severe acute pancreatitis
  • Patients with organs failure
  • Patients receiving enteral feeding
  • Excessive alcohol intake (greater than 15 consumptions per week)
  • (planned) pregnancy or lactation
  • Use of pre-, probiotics in the month before and during the study
  • Use of antibiotics in the two months before and during the study
  • Use of anti-diarrhoea medication, anti-laxatives or anti-acid medication in the two weeks before and during the study
  • Use of anti depressives (especially SSRI's) in the month before and during the study
  • Use of other medication if less then one month on stable dosage

Sites / Locations

  • University Hospital Maastricht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Pain tolerance threshold
VAS score for pain at pressure step 29 mmHg

Secondary Outcome Measures

Full Information

First Posted
June 11, 2008
Last Updated
January 28, 2013
Sponsor
Maastricht University Medical Center
Collaborators
Winclove Bio Industries BV
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1. Study Identification

Unique Protocol Identification Number
NCT00702026
Brief Title
The Effect of a Multispecies Probiotic on Hypersensitivity in Irritable Bowel Syndrome (IBS) Patients
Official Title
The Effect of a Multispecies Probiotic on Hypersensitivity in IBS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Winclove Bio Industries BV

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether a specifically designed multispecies probiotic decreases visceral hypersensitivity in IBS-patient (defined by an increased pain tolerance threshold). Moreover, the effect on general symptom scores and inflammatory and microbiological parameters will be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Hypersensitivity
Keywords
Irritable Bowel Syndrome, Hypersensitivity, Probiotics, Multispecies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
multispecies probiotic (Ecologic 801)
Other Intervention Name(s)
Ecologic 801
Intervention Description
once daily, 5 gram [10e9 cfu/gram]
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
once daily, 5 gram [10e9 cfu/gram]
Primary Outcome Measure Information:
Title
Pain tolerance threshold
Time Frame
t=0 and t=6 weeks
Title
VAS score for pain at pressure step 29 mmHg
Time Frame
t=0 and t=6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of IBS according to the Rome III criteria Increased visceral perception according to barostat measurements, defined as a pain tolerance threshold at smaller than or equal to 23 mmHg Age between 18 and 65 years BMI between 18.5 and 30 kg/m2 Exclusion Criteria: Known gastro-intestinal diseases Major abdominal surgery Previous radiotherapy, chemotherapy Clinical significant systemic diseases Critically ill patients or patients suffering from severe acute pancreatitis Patients with organs failure Patients receiving enteral feeding Excessive alcohol intake (greater than 15 consumptions per week) (planned) pregnancy or lactation Use of pre-, probiotics in the month before and during the study Use of antibiotics in the two months before and during the study Use of anti-diarrhoea medication, anti-laxatives or anti-acid medication in the two weeks before and during the study Use of anti depressives (especially SSRI's) in the month before and during the study Use of other medication if less then one month on stable dosage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A AM Masclee, Prof. Dr.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Maastricht
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24920528
Citation
Ludidi S, Mujagic Z, Jonkers D, Keszthelyi D, Hesselink M, Kruimel J, Conchillo J, Masclee A. Markers for visceral hypersensitivity in patients with irritable bowel syndrome. Neurogastroenterol Motil. 2014 Aug;26(8):1104-11. doi: 10.1111/nmo.12365. Epub 2014 Jun 11.
Results Reference
derived
PubMed Identifier
24588932
Citation
Ludidi S, Jonkers DM, Koning CJ, Kruimel JW, Mulder L, van der Vaart IB, Conchillo JM, Masclee AA. Randomized clinical trial on the effect of a multispecies probiotic on visceroperception in hypersensitive IBS patients. Neurogastroenterol Motil. 2014 May;26(5):705-14. doi: 10.1111/nmo.12320. Epub 2014 Mar 4.
Results Reference
derived

Learn more about this trial

The Effect of a Multispecies Probiotic on Hypersensitivity in Irritable Bowel Syndrome (IBS) Patients

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