Ulcerative ColitisNCT00951548
Food Supplementation With VSL#3 as a Support to Standard Pharmaceutical Therapy in Ulcerative Colitis
A study testing VSL#3 in people with Ulcerative Colitis, run by VSL Pharmaceuticals at 13 sites in Italy.
Trial summary
This is a double-blind, randomized, placebo controlled study to assess the beneficial effects of food supplementation with VSL#3 as a support to standard pharmaceutical therapy in patients affected by mild to moderate active ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- VSL#3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 13 sitesItaly
- Study dates
- Oct 2006to Oct 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged more than 18 years;
- Diagnosis of ulcerative colitis established by previous colonoscopy, with consistent histology and clinical course;
- Ulcerative colitis extending for more than 15 cm from the anal verge, that is involving at least the rectosigmoid. This is based on colonoscopy at any time since the onset of ulcerative colitis. Activity (not extent) must be confirmed by colonoscopy at the beginning of the study;
- Mild to moderate active ulcerative colitis. Patients must have a minimum score of 3 and a maximum score of 8 on the 12 point UCDAI (Ulcerative Colitis Disease Activity Index - see Appendix 3) that measures stool frequency, rectal bleeding, endoscopic findings and physician's overall assessment of disease severity;
- Symptomatic (current episode) for less than 4 weeks;
- Minimum endoscopic score of 2 on the UCDAI at screening (mucosal appearance);
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- Use of oral 5-ASA at least 4 weeks prior to study entry, at same dose; and/or use of Azathioprine or 6-mercaptopurine at least 3 months prior to study entry, at same dose;
- Negative pregnancy test on screening and agreeing to use valid contraception for the duration of the study;
- Patient not requiring hospitalisation;
- Willing an able to provide written informed consent
Who cannot join
- Crohn's disease or pouchitis;
- UCDAI greater than 8 (need for emergency surgery or presence of severe disease;
- Use of oral steroids within the last 4 weeks prior to study entry;
- Use of antibiotics within the last 2 weeks prior to study entry;
- Change in dose of oral 5-ASA within the last 4 weeks prior to study entry and throughout the 8 week study period, or change in dose of oral 6-mercaptopurine and azathioprine drugs within the last 3 months prior to study entry and throughout the 8 week study period;
- Use of rectal 5-ASA or steroids for one week before and throughout the 8 week study period;
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- Use of probiotic preparations either prescribed or over-the-counter within 2 weeks prior to study entry;
- Use of NSAIDS for one week before and throughout the 8 week study period;
- Significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the Investigator;
- History of severe adverse reaction or known hypersensitivity to maltose and/or silicon dioxide;
- Patient requiring hospitalisation;
- Pregnant or lactating women, or women of child bearing potential not using an acceptable form of birth control (negative pregnancy test also required);
- Use of any investigational drug and/or participation in any clinical trial within 3 months of entry to this study;
- Inability to give a valid informed consent or to properly follow the protocol
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites
U.O. di Medicina Interna Ospedaliera Policlinico di Bari
Bari, 70023
Reparto di Gastroenterologia ed Endoscopia Digestiva Azienda Ospedaliera Pugliese-Ciaccio
Catanzaro, 88100
U.O. Fisiopatologia Digestiva Azienda Ospedaliera Mater Domini Campus Universitario di Germaneto
Catanzaro, 88100
U.O. di Endoscopia Digestiva Presidio Ospedaliero San Salvatore
L’Aquila, 67100
Dipartimento di Chirurgia Generale Servizio di Endoscopia Digestiva Ospedale Santa Maria Goretti
Latina, 04100
Struttura Complessa di Medicina Interna Azienda Ospedaliera Villa Sofia - CTO Ospedale Villa Sofia
Palermo, 90146
U.O. di Nutrizione Clinica Ospedale Sant'Eugenio
Roma, 00144
P.O. Nuovo Regina Margherita Unità Operativa di Endoscopia e Gastroenterologia
Roma, 00153
Dipartimento di Medicina Interna U.O. di Gastroenterologia ed Endoscopia Digestiva Ospedale Cristo Re
Roma, 00167
Istituto di Medicina Interna CIC Columbus Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore
Roma, 00168
Unità di Endoscopia Azienda Ospedaliera Sant'Andrea
Roma, 00189
Divisione di Gastroenterologia Istituto Clinico Humanitas
Rozzano (MI), 20089
U.O.C. Endoscopia Digestiva IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo (FG), 71013
About this study
Official title: Food Supplementation With the Probiotic Preparation VSL#3 as a Support to Standard Pharmaceutical Therapy in Patients With Mild to Moderate Active Ulcerative Colitis. A Double-blind, Randomized, Placebo Controlled Study
This is a double-blind, randomized, placebo controlled study to assess the beneficial effects of food supplementation with VSL#3 as a support to standard pharmaceutical therapy in patients affected by mild to moderate active ulcerative colitis.
Read the detailed description
Title:
Food supplementation with the probiotic preparation VSL#3 as a support to standard pharmaceutical therapy in patient with mild to moderate active Ulcerative Colitis. A double-blind, randomized, placebo controlled study.
Study Design:
Double blind, randomised, parallel groups, placebo controlled, multicentre, national study.
Study Period:
February 2006 - October 2007 (recruitment: 12 months; food supplementation with VSL#3: 8 weeks).
Study Population:
The study population will comprise 144 patients with mild to moderate active ulcerative colitis on top of standard pharmaceutical therapy. 72 patients will be randomised to receive food supplementation VSL#3 and 72 to receive placebo.
Total Number of centers:
Approximately 16
Study Objectives:
To assess the beneficial effects of food supplementation with VSL#3 in patients affected by mild to moderate active ulcerative colitis in a double-blind, placebo-controlled study.
Study product:
VSL#3 consists of sachets each containing 900 billion viable lyophilised bacteria, comprising 4 strains of Lactobacillus (L. paracasei, L. plantarum, L. acidophilus and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacterium (B. longum, B. breve and B. infantis) and 1 strain of Streptococcus thermophilus, in maltose and silicon dioxide as excipients.
The placebo is in the form of identical sachets containing only maltose and silicon dioxide.
The dose which will receive each patients is two sachets of VSL#3 or placebo to take twice a day orally (total amount of bacteria: 3.600 billion organisms per day).
Assessments:
Primary Outcome The primary outcome is the evaluation of the beneficial effects of food supplementation with VSL#3 in patients affected by UC, assessed by a decrease in the UCDAI of 50% or more, from baseline to week 8.
Secondary Outcomes:
Assessment of the beneficial effects of the food supplementation with the probiotic preparation VSL#3 on:
- activity of ulcerative colitis.
- change in subjective symptoms (rectal bleeding and stool frequency) from baseline to weeks 2, 4 and 8 of food supplementation with VSL#3.
- lack of beneficial effects, defined by need for further food supplementation or inability to stay on study till week 8.
- quality of life questionnaire (IBDQ)
- concordance between the Physician and Patient Global Assessment Scale at each time point.
Physical Status Evaluations:
Assessment of haematological laboratory tests, vital signs (blood pressure, pulse rate and respiratory rate), medical history and physical examination.
- Conditions
- Ulcerative Colitis
- Being tested
- VSL#3, Placebo
- Keywords
- Probiotics, VSL#3, Double-blind, Placebo controlled
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSL#3Dietary supplement
Probiotic blend of 8 different strains of lactobacilli and bifidobacteria, dosed at 900 billion bacteria/sachet). Dosage regimen is 2 sachets b.i.d. for 8 weeks
PlaceboDietary supplement
Corn Starch. Dosage regimen is 2 sachets b.i.d. for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| VSL#3 | Experimental | Probiotic preparation VSL#3 Receives: Dietary Supplement: VSL#3 |
| placebo | Placebo comparator | Corn Starch Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the evaluation of the beneficial effects of food supplementation with VSL#3 in patients affected by UC, assessed by a decrease in the UCDAI of 50% or more
Measured: 8 weeks
Secondary outcomes (4)
Activity of ulcerative colitis
Measured: 8 weeks
Change in subjective symptoms from baseline to weeks 2, 4 and 8 of food supplementation with VSL#3
Measured: 8 weeks
Lack of beneficial effects, defined by need for further food supplementation
Measured: 8 weeks
Inability to stay on study
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startOct 2006
- Study completionOct 2008
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- VSL Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Claudio De Simone, Prof., Study director, VSL Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951548
- Sponsor's protocol ID
- VSL-UC-03
- Status last verified
- Aug 2009
- First submitted
- 2 Aug 2009
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Supplementation With the Probiotic Preparation VSL#3 as a Support to Standard Pharmaceutical Therapy in Patients With Mild to Moderate Active Ulcerative Colitis. A Double-blind, Randomized, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT00951548
- Acronym / sponsor ID
- VSL-UC-03
- Conditions
- Ulcerative Colitis
- Keywords
- Probiotics, VSL#3, Double-blind, Placebo controlled
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- VSL PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Oct 2008 (actual)
- First posted
- 4 Aug 2009 (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.
This is a double-blind, randomized, placebo controlled study to assess the beneficial effects of food supplementation with VSL#3 as a support to standard pharmaceutical therapy in patients affected by mild to moderate active ulcerative colitis.
Detailed description
Title:
Food supplementation with the probiotic preparation VSL#3 as a support to standard pharmaceutical therapy in patient with mild to moderate active Ulcerative Colitis. A double-blind, randomized, placebo controlled study.
Study Design:
Double blind, randomised, parallel groups, placebo controlled, multicentre, national study.
Study Period:
February 2006 - October 2007 (recruitment: 12 months; food supplementation with VSL#3: 8 weeks).
Study Population:
The study population will comprise 144 patients with mild to moderate active ulcerative colitis on top of standard pharmaceutical therapy. 72 patients will be randomised to receive food supplementation VSL#3 and 72 to receive placebo.
Total Number of centers:
Approximately 16
Study Objectives:
To assess the beneficial effects of food supplementation with VSL#3 in patients affected by mild to moderate active ulcerative colitis in a double-blind, placebo-controlled study.
Study product:
VSL#3 consists of sachets each containing 900 billion viable lyophilised bacteria, comprising 4 strains of Lactobacillus (L. paracasei, L. plantarum, L. acidophilus and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacterium (B. longum, B. breve and B. infantis) and 1 strain of Streptococcus thermophilus, in maltose and silicon dioxide as excipients.
The placebo is in the form of identical sachets containing only maltose and silicon dioxide.
The dose which will receive each patients is two sachets of VSL#3 or placebo to take twice a day orally (total amount of bacteria: 3.600 billion organisms per day).
Assessments:
Primary Outcome The primary outcome is the evaluation of the beneficial effects of food supplementation with VSL#3 in patients affected by UC, assessed by a decrease in the UCDAI of 50% or more, from baseline to week 8.
Secondary Outcomes:
Assessment of the beneficial effects of the food supplementation with the probiotic preparation VSL#3 on:
- activity of ulcerative colitis.
- change in subjective symptoms (rectal bleeding and stool frequency) from baseline to weeks 2, 4 and 8 of food supplementation with VSL#3.
- lack of beneficial effects, defined by need for further food supplementation or inability to stay on study till week 8.
- quality of life questionnaire (IBDQ)
- concordance between the Physician and Patient Global Assessment Scale at each time point.
Physical Status Evaluations:
Assessment of haematological laboratory tests, vital signs (blood pressure, pulse rate and respiratory rate), medical history and physical examination.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VSL#3 | Experimental | Dietary Supplement: VSL#3Probiotic preparation VSL#3 |
| placebo | Placebo comparator | Dietary Supplement: PlaceboCorn Starch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female patients aged more than 18 years;
- Diagnosis of ulcerative colitis established by previous colonoscopy, with consistent histology and clinical course;
- Ulcerative colitis extending for more than 15 cm from the anal verge, that is involving at least the rectosigmoid. This is based on colonoscopy at any time since the onset of ulcerative colitis. Activity (not extent) must be confirmed by colonoscopy at the beginning of the study;
- Mild to moderate active ulcerative colitis. Patients must have a minimum score of 3 and a maximum score of 8 on the 12 point UCDAI (Ulcerative Colitis Disease Activity Index - see Appendix 3) that measures stool frequency, rectal bleeding, endoscopic findings and physician's overall assessment of disease severity;
- Symptomatic (current episode) for less than 4 weeks;
Key exclusion criteria (14 listed)
- Crohn's disease or pouchitis;
- UCDAI greater than 8 (need for emergency surgery or presence of severe disease;
- Use of oral steroids within the last 4 weeks prior to study entry;
- Use of antibiotics within the last 2 weeks prior to study entry;
- Change in dose of oral 5-ASA within the last 4 weeks prior to study entry and throughout the 8 week study period, or change in dose of oral 6-mercaptopurine and azathioprine drugs within the last 3 months prior to study entry and throughout the 8 week study period;
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 |
|---|---|---|
| VSL#3Probiotic blend of 8 different strains of lactobacilli and bifidobacteria, dosed at 900 billion bacteria/sachet). Dosage regimen is 2 sachets b.i.d. for 8 weeks | Dietary supplement | VSL#3 |
| PlaceboCorn Starch. Dosage regimen is 2 sachets b.i.d. for 8 weeks | Dietary supplement | placebo |
Primary outcome
The primary outcome is the evaluation of the beneficial effects of food supplementation with VSL#3 in patients affected by UC, assessed by a decrease in the UCDAI of 50% or more
Time frame: 8 weeks
4 secondary outcomes
Activity of ulcerative colitis
Time frame: 8 weeks
Change in subjective symptoms from baseline to weeks 2, 4 and 8 of food supplementation with VSL#3
Time frame: 8 weeks
Lack of beneficial effects, defined by need for further food supplementation
Time frame: 8 weeks
Inability to stay on study
Time frame: 8 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 4 Aug 2009.
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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.
Claudio De Simone, Prof. study director
VSL Pharmaceuticals
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VSL#3 in people with Ulcerative Colitis, run by VSL Pharmaceuticals at 13 sites in Italy.
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 10 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 4 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. 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?
The primary outcome is the evaluation of the beneficial effects of food supplementation with VSL#3 in patients affected by UC, assessed by a decrease in the UCDAI of 50% or more (time frame: 8 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 4 Aug 2009.