The effect of a multispecies probiotic on hypersensitivity in IBS patients

Completed

Conditions: Irritable Bowel Syndrome
10017977
spastic colon

Registration Number: NL-OMON35347

Lead Sponsor: Interne Geneeskunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 70

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 < 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
- Clinical significant systemic diseases
- 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 selective serotonin-reuptake inhibitors) in the month before and during the study
- Use of other medication if less then one month on stable dosage

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Pain tolerance threshold.<br /><br>- VAS score for pain at pressure step 29 mmHg<br /><br><br /><br><br /><br><br /><br>Perception threshold<br /><br>Perception thresholds (i.e. pain, urge and discomfort) are defined as the first<br /><br>pressure level at which the perception score (by 10 cm visual analogue scale)<br /><br>exceeds 1 cm.<br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Urge and discomfort tolerance threshold<br /><br>- Vas score for urge and discomfort at pressure step 29 mmHg<br /><br>- Pressure step at which the VAS for pain, urge and discomfort increases 10mm<br /><br>compared to the baseline score<br /><br>- Compliance (barostat)<br /><br>- Symptom scores (daily) by validated questionnaires<br /><br>- Whole blood cytokine levels of IL-10, IL-12 , TNF-* and IL-1*.<br /><br>- Intestinal permeability by lactulose/rhamnose and sucralose<br /><br>- Changes in faecal microbiota and protease activity</p><br>