Irritable Bowel SyndromeNCT00702026
The Effect of a Multispecies Probiotic on Hypersensitivity in Irritable Bowel Syndrome (IBS) Patients
A study testing multispecies probiotic (Ecologic 801) in people with Irritable Bowel Syndrome and Hypersensitivity, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome, Hypersensitivity
- What is being tested?
- multispecies probiotic (Ecologic 801)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Multispecies Probiotic on Hypersensitivity in 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.
- Conditions
- Irritable Bowel Syndrome, Hypersensitivity
- Being tested
- multispecies probiotic (Ecologic 801), Placebo
- Keywords
- Irritable Bowel Syndrome, Hypersensitivity, Probiotics, Multispecies
- Medical subject headings
- Irritable Bowel Syndrome, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multispecies probiotic (Ecologic 801)Dietary supplement
Also called Ecologic 801
once daily, 5 gram [10e9 cfu/gram]
PlaceboDietary supplement
once daily, 5 gram [10e9 cfu/gram]
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Dietary Supplement: multispecies probiotic (Ecologic 801) |
| 2 | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain tolerance threshold
Measured: t=0 and t=6 weeks
VAS score for pain at pressure step 29 mmHg
Measured: t=0 and t=6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Winclove Bio Industries BV
- Responsible party
- Sponsor
- Investigators
- A AM Masclee, Prof. Dr., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702026
- Sponsor's protocol ID
- MEC 08-1-031
- Status last verified
- Jan 2013
- First submitted
- 11 Jun 2008
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24920528Ludidi 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.
PubMed 24588932
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Multispecies Probiotic on Hypersensitivity in IBS Patients
- ClinicalTrials.gov ID
- NCT00702026
- Acronym / sponsor ID
- MEC 08-1-031
- Conditions
- Irritable Bowel Syndrome, Hypersensitivity
- Keywords
- Irritable Bowel Syndrome, Hypersensitivity, Probiotics, Multispecies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Winclove Bio Industries BV
- Study start
- Aug 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: multispecies probiotic (Ecologic 801) |
| 2 | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Known gastro-intestinal diseases
- Major abdominal surgery
- Previous radiotherapy, chemotherapy
- Clinical significant systemic diseases
- Critically ill patients or patients suffering from severe acute pancreatitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multispecies probiotic (Ecologic 801)Also: Ecologic 801once daily, 5 gram [10e9 cfu/gram] | Dietary supplement | 1 |
| Placeboonce daily, 5 gram [10e9 cfu/gram] | Dietary supplement | 2 |
Primary outcome
Pain tolerance threshold
Time frame: t=0 and t=6 weeks
VAS score for pain at pressure step 29 mmHg
Time frame: t=0 and t=6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
- Derived from this study: PubMed 24920528Ludidi 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.
- Derived from this study: PubMed 24588932Ludidi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A AM Masclee, Prof. Dr. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multispecies probiotic (Ecologic 801) in people with Irritable Bowel Syndrome and Hypersensitivity, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain tolerance threshold (time frame: t=0 and t=6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00702026, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2013.