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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Irritable Bowel Syndrome Hypersensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

multispecies probiotic (Ecologic 801)

Intervention Type DIETARY_SUPPLEMENT

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

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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multispecies probiotic (Ecologic 801)

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Ecologic 801

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No