Ulcerative ColitisCUPIDONCT02361957
The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients
A study testing Ecologic 825 in people with Ulcerative Colitis, run by Wageningen University at 1 site in Netherlands.
Trial summary
RATIONALE: The underlying etiology in inflammatory bowel diseases such as Ulcerative Colitis is not yet fully understood. Studies suggest a relation between higher intestinal permeability and aberrant changes of the epithelium. Dysbiosis of the intestinal microbiota might be the cause. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Ecologic 825
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2014to Dec 2015
- 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
- Diagnosed Ulcerative Colitis (left sided UC or pancolitis)
- Age 18-65 (because microbiota change at older age)
- Stable disease activity (clinical remission with CRP levels <10mg/L and calprotectin <100 ug/g) as measured at baseline
- Mild disease activity (P-SCCAI <5)
- Mesalazine medication as only medication for UC with a maximum intake of 2.4 g/day
Who cannot join
- History of intestinal surgery that might interfere with the outcome of the study
- Diabetes Mellitus (medication dependent)
- Current use of antibiotics
- Current use of corticosteroids (30 days prior to the first baseline measurement).
- Treatment with other medication besides mesalazine (NSAIDs, topical or systemic steroids, immunosuppressive drugs or aspirin) one week prior the first baseline measurement.
- Use of other pre- and probiotics and not willing to stop these 2 weeks before the intervention period
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- Hypersensitivity or allergy to milk protein, soy protein and gluten
- Alcohol abuse (male more than 14 servings a week, female more than 7 servings a week)
- Female patients: currently pregnant or breast-feeding or intending to become pregnant during the study
- Patients foreseen to need GI surgery during the study period
- Patients with a history of cancer
Trial locations and contacts
1 site in 1 country.
About this study
RATIONALE: The underlying etiology in inflammatory bowel diseases such as Ulcerative Colitis is not yet fully understood. Studies suggest a relation between higher intestinal permeability and aberrant changes of the epithelium. Dysbiosis of the intestinal microbiota might be the cause. Probiotics may restore the balance of the intestinal microbiota. In theory this could improve intestinal permeability and therefore reduce disease activity and maintain remission in patients with Ulcerative Colitis.
OBJECTIVE: To investigate whether a specifically designed multispecies probiotic mixture (ecologic 825®), as adjuvant therapy, can contribute to an improvement of intestinal permeability, microbiota composition, disease activity and inflammatory markers in ulcerative colitis.
Read more
STUDY DESIGN: 12-wk placebo-controlled randomized double-blind intervention with 2 parallel arms.
STUDY POPULATION: Adults diagnosed with left sided Ulcerative Colitis or Pancolitis in remission or mild stage of the disease. For inclusion of the patients the Patient Simple Clinical Colitis Activity Index (P-SCCAI) will be used.
INTERVENTION: Patients will receive either two daily dosages of 3 g of Ecologic® 825 or two daily doses of 3 g of the placebo, containing only the carrier material (both produced by Winclove Probiotics).
MAIN STUDY PARAMETERS/ENDPOINTS: Main study parameter is intestinal permeability measured by several techniques: the lactulose/mannitol absorption test (L/M test), LPS levels in blood serum and faecal zonulin. Secondary, inflammation will be measured from faecal calprotectin and blood c-reactive protein (CRP) levels. Furthermore samples will be stored to measure cytokine concentrations in serum and to analyse the microbial composition of the faecal samples using the HITchip. For the disease related quality of life the irritable bowel disease questionnaire (IBD-Q) and SF-36 will be used. All parameters will be measured at three time points; t=0, t=6 and t=12 weeks.
- Conditions
- Ulcerative Colitis
- Being tested
- Ecologic 825, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecologic 825Dietary supplement
Also called PRO.IB
Multispecies probiotic product, 2.5 x10E9 colony forming units per gram, 6 grams a day
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Active comparator | Multispecies probiotic product Ecologic 825, 2x10-9 colony forming units per gram, 6 grams per day. Receives: Dietary Supplement: Ecologic 825 |
| Placebo | Placebo comparator | Similar in appearance as the probiotics, but not containing any bacteria. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal permeability measured by the Lactulose Mannitol test (L/M test)
Measured by the Lactulose Mannitol ratio in urine (L/M test)
Measured: 12 weeks
Secondary outcomes (8)
blood CRP levels
inflammatory marker
Measured: 6 and 12 weeks
fecal calprotectin levels
marker of intestinal inflammation
Measured: 6 and 12 weeks
Quality of life (measured by IBD-Q and SF36)
Disease related quality of life will be measured by IBD-Q and SF36
Measured: 6 and 12 weeks
Intestinal permeability measured by the Lactulose Mannitol test (L/M test)
Measured by the Lactulose Mannitol ratio in urine (L/M test)
Measured: 6 weeks
Lipopolysaccharides levels in blood
A marker for intestinal permeability and inflammation
Measured: 6 and 12 weeks
Intestinal permeability measured by faecal zonulin levels
Measured by faecal zonulin levels
Measured: 6 and 12 weeks
microbiota composition
measured by human intestinal tract (HIT-chip) microarray
Measured: 6 and 12 weeks
interferon gamma levels
measured in plasma samples
Measured: 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: We recruited 25 of the 40 participants from intended study population. Recruitment in new populations requires an METC amendment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole De Roos, PhD, Principal investigator, Wageningen UR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361957
- Sponsor's protocol ID
- NL46674.081.13
- Acronym
- CUPIDO
- Status last verified
- Aug 2015
- First submitted
- 15 Jan 2015
- Last updated
- 28 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients
- ClinicalTrials.gov ID
- NCT02361957
- Acronym / sponsor ID
- CUPIDO / NL46674.081.13
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: We recruited 25 of the 40 participants from intended study population. Recruitment in new populations requires an METC amendment.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 12 Feb 2015 (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.
RATIONALE: The underlying etiology in inflammatory bowel diseases such as Ulcerative Colitis is not yet fully understood. Studies suggest a relation between higher intestinal permeability and aberrant changes of the epithelium. Dysbiosis of the intestinal microbiota might be the cause. Probiotics may restore the balance of the intestinal microbiota. In theory this could improve intestinal permeability and therefore reduce disease activity and maintain remission in patients with Ulcerative Colitis.
OBJECTIVE: To investigate whether a specifically designed multispecies probiotic mixture (ecologic 825®), as adjuvant therapy, can contribute to an improvement of intestinal permeability, microbiota composition, disease activity and inflammatory markers in ulcerative colitis.
STUDY DESIGN: 12-wk placebo-controlled randomized double-blind intervention with 2 parallel arms.
STUDY POPULATION: Adults diagnosed with left sided Ulcerative Colitis or Pancolitis in remission or mild stage of the disease. For inclusion of the patients the Patient Simple Clinical Colitis Activity Index (P-SCCAI) will be used.
INTERVENTION: Patients will receive either two daily dosages of 3 g of Ecologic® 825 or two daily doses of 3 g of the placebo, containing only the carrier material (both produced by Winclove Probiotics).
MAIN STUDY PARAMETERS/ENDPOINTS: Main study parameter is intestinal permeability measured by several techniques: the lactulose/mannitol absorption test (L/M test), LPS levels in blood serum and faecal zonulin. Secondary, inflammation will be measured from faecal calprotectin and blood c-reactive protein (CRP) levels. Furthermore samples will be stored to measure cytokine concentrations in serum and to analyse the microbial composition of the faecal samples using the HITchip. For the disease related quality of life the irritable bowel disease questionnaire (IBD-Q) and SF-36 will be used. All parameters will be measured at three time points; t=0, t=6 and t=12 weeks.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Active comparator | Dietary Supplement: Ecologic 825Multispecies probiotic product Ecologic 825, 2x10-9 colony forming units per gram, 6 grams per day. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSimilar in appearance as the probiotics, but not containing any bacteria. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed Ulcerative Colitis (left sided UC or pancolitis)
- Age 18-65 (because microbiota change at older age)
- Stable disease activity (clinical remission with CRP levels <10mg/L and calprotectin <100 ug/g) as measured at baseline
- Mild disease activity (P-SCCAI <5)
- Mesalazine medication as only medication for UC with a maximum intake of 2.4 g/day
Key exclusion criteria (11 listed)
- History of intestinal surgery that might interfere with the outcome of the study
- Diabetes Mellitus (medication dependent)
- Current use of antibiotics
- Current use of corticosteroids (30 days prior to the first baseline measurement).
- Treatment with other medication besides mesalazine (NSAIDs, topical or systemic steroids, immunosuppressive drugs or aspirin) one week prior the first baseline measurement.
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 |
|---|---|---|
| Ecologic 825Also: PRO.IBMultispecies probiotic product, 2.5 x10E9 colony forming units per gram, 6 grams a day | Dietary supplement | Probiotics |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
Intestinal permeability measured by the Lactulose Mannitol test (L/M test)
Time frame: 12 weeks
Measured by the Lactulose Mannitol ratio in urine (L/M test)
8 secondary outcomes
blood CRP levels
Time frame: 6 and 12 weeks
fecal calprotectin levels
Time frame: 6 and 12 weeks
Quality of life (measured by IBD-Q and SF36)
Time frame: 6 and 12 weeks
Intestinal permeability measured by the Lactulose Mannitol test (L/M test)
Time frame: 6 weeks
Lipopolysaccharides levels in blood
Time frame: 6 and 12 weeks
Intestinal permeability measured by faecal zonulin levels
Time frame: 6 and 12 weeks
microbiota composition
Time frame: 6 and 12 weeks
interferon gamma levels
Time frame: 6 and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2015.
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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.
Nicole De Roos, PhD principal investigator
Wageningen UR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecologic 825 in people with Ulcerative Colitis, run by Wageningen University 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 5 inclusion and 11 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: paused, as of the sponsor's last update on 28 Aug 2015. 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?
Results are not available in the source record.
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?
Intestinal permeability measured by the Lactulose Mannitol test (L/M test) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2015.