Clinical trial NCT00702026: 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
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Hypersensitivity
Keywords: Irritable Bowel Syndrome
Hypersensitivity
Probiotics
Multispecies
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Winclove Bio Industries BV
First posted: 2008-06-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain tolerance threshold
timeFrame: t=0 and t=6 weeks
measure: VAS score for pain at pressure step 29 mmHg
timeFrame: t=0 and t=6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: University Hospital Maastricht
Study officials:
affiliation: Maastricht University Medical Center
name: A AM Masclee, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.