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

Maastricht University Medical Centre (MUMC) logo

Maastricht University Medical Centre (MUMC)

Status

Completed

Conditions

Irritable Bowel Syndrome
Hypersensitivity

Treatments

Dietary Supplement: multispecies probiotic (Ecologic 801)
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00702026
MEC 08-1-031

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

1
Experimental group
Treatment:
Dietary Supplement: multispecies probiotic (Ecologic 801)
2
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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