NCT00702026

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 11, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

3.3 years

First QC Date

June 11, 2008

Last Update Submit

January 28, 2013

Conditions

Irritable Bowel SyndromeHypersensitivity

Keywords

Irritable Bowel SyndromeHypersensitivityProbioticsMultispecies

Outcome Measures

Primary Outcomes (2)

  • Pain tolerance threshold

    t=0 and t=6 weeks

  • VAS score for pain at pressure step 29 mmHg

    t=0 and t=6 weeks

Study Arms (2)

1

EXPERIMENTAL
Dietary Supplement: multispecies probiotic (Ecologic 801)

2

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

multispecies probiotic (Ecologic 801)DIETARY_SUPPLEMENT

once daily, 5 gram \[10e9 cfu/gram\]

Also known as: Ecologic 801
1
PlaceboDIETARY_SUPPLEMENT

once daily, 5 gram \[10e9 cfu/gram\]

2

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Maastricht

Maastricht, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 24920528DERIVED

  • 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.

    PMID: 24588932DERIVED

MeSH Terms

Conditions

Irritable Bowel SyndromeHypersensitivity

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesImmune System Diseases

Study Officials

  • A AM Masclee, Prof. Dr.

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2008

First Posted

June 19, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

NL(1)