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

Irritable Bowel Syndrome Clinical Trial

Official title:

The Effect of a Multispecies Probiotic on Hypersensitivity in IBS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702026
• Other study ID #: MEC 08-1-031
• Status: Completed
• Phase: N/A
• First received: June 11, 2008
• Last updated: January 28, 2013
• Start date: August 2008
• Est. completion date: December 2011

Study information

• Verified date: January 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypersensitivity
• Irritable Bowel Syndrome

Intervention

Dietary Supplement:
• multispecies probiotic (Ecologic 801)
once daily, 5 gram [10e9 cfu/gram]
• Placebo
once daily, 5 gram [10e9 cfu/gram]

Locations

Country	Name	City	State
Netherlands	University Hospital Maastricht	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Winclove Bio Industries BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain tolerance threshold		t=0 and t=6 weeks	No
Primary	VAS score for pain at pressure step 29 mmHg		t=0 and t=6 weeks	No