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OpenTrials
Completed

NCT Number: NCT00702026

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Hypersensitivity Immune System Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Maastricht

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

multispecies probiotic (Ecologic 801)

Dietary Supplement

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

Other names: Ecologic 801

Placebo

Dietary Supplement

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

Primary outcomes

  1. Pain tolerance threshold

    Time frame: t=0 and t=6 weeks

  2. VAS score for pain at pressure step 29 mmHg

    Time frame: t=0 and t=6 weeks

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Winclove Bio Industries BV

Registry information

Official study title

The Effect of a Multispecies Probiotic on Hypersensitivity in IBS Patients

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 19, 2008
Registry last updated
Jan 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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