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

The Effect of a Multispecies Probiotic on Hypersensitivity in IBS Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00702026

Enrollment

Registered

2008-06-19

Start date

2008-08-31

Completion date

2011-12-31

Last updated

2013-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypersensitivity, Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome, Hypersensitivity, Probiotics, Multispecies

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.

Interventions

DIETARY_SUPPLEMENTmultispecies probiotic (Ecologic 801)

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

DIETARY_SUPPLEMENTPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Pain tolerance threshold	t=0 and t=6 weeks
VAS score for pain at pressure step 29 mmHg	t=0 and t=6 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026