Trial | NCT00702026  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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.
Study Started
Aug 31
2008
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2011
Last Update
Jan 29
2013
Estimate

Dietary Supplement multispecies probiotic (Ecologic 801)

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

  • Other names: Ecologic 801

Dietary Supplement Placebo

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

1 Experimental

2 Placebo Comparator

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
No Results Posted