Ulcerative ColitisPROREM UCNCT03415711
PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis
A study testing VSL#3® and Mesalamine in people with Ulcerative Colitis, run by VSL Pharmaceuticals at 1 site in Italy.
Trial summary
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation limited to colonic mucosa. Its pathogenesis is not still clear, even if a multifactorial aetiology has been advocated. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- VSL#3® and Mesalamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteItaly
- Study dates
- 28 Apr 2017to 24 Apr 2019
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- Subjects are willing and able to participate in the study, complete subject assessments, attend scheduled clinic visits, and comply with all protocol requirements as evidenced by written informed consent.
- Male and/or female subjects aged ≥18 years at the time of informed consent.
- A diagnosis of UC for ≥3 months. A biopsy report must be available to confirm the histological diagnosis in the subject's source documentation. In addition, a report documenting disease duration and extent of disease (e.g., proctosigmoiditis, left-sided colitis and pancolitis) based upon prior colonoscopy must also be available in source documentation.
- Must have a flexible sigmoidoscopy indicative of UC in remission (Mayo endoscopic subscore ≤1) during screening period, to be performed after all other inclusion criteria have been met.
- Must have history of previous mild-to-moderate active disease beyond the rectum (>15 cm from the anal verge).
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- Must have UC in remission with a Total Mayo Score ≤2 with no individual subscore>1 and rectal bleed subscore of 0.
- Must be on maintenance treatment with oral mesalamine (<2.5 g/day), sulfasalazine (<3.0 g/day) or olsalazine (<1.5 g/day) on a stable dose for at least 2 weeks before randomization.
- Male and female subjects of childbearing potential must agree to avoid pregnancy throughout the duration of the study (defined as the time of the signing of the informed consent through the conclusion of subject participation). A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test result at screening. WOCBP are defined as women who are biologically capable of becoming pregnant, including women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
- Women of non-childbearing potential (WONCBP) do not require a urine pregnancy test and must meet at least one of the following criteria:
- Have undergone hysterectomy or bilateral oophorectomy;
- Have medically confirmed ovarian failure or are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; laboratory confirmation of Follicle-stimulating hormone (FSH) level may be indicated if subject has history of amenorrhea for ≥ 52 weeks).
- Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; laboratory confirmation of FSH level may be indicated if subject has history of amenorrhea for ≥ 52 weeks).
Who cannot join
- Subjects with a diagnosis of indeterminate colitis or Crohn's disease. Subjects with clinical findings suggestive of Crohn's disease, e.g., fistulae or granulomas on biopsy are also excluded.
- Subjects with colonic dysplasia or neoplasia.
- Subjects with a history of colonic or small bowel obstruction or resection, except for appendectomy.
- Use of rectal 5-aminosalicylic acid or systemic or rectal corticosteroids within 30 days before baseline, use of immunosuppressive agents within 12 weeks before baseline.
- Use of antitumor necrosis factor (anti-TNFα) or anti-integrin therapy for UC at any moment of previous patient history 6. Repeated use of non-steroidal anti-inflammatory drugs (NSAIDs), including the non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen (except for prophylactic use of a stable dose of aspirin up to 325 mg / day for cardiac disease). Occasional use of NSAIDs is permitted.
- 8. Subjects who had received another investigational agent within 30 days before baseline.
- 9. Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic, or local active infection/infectious illness) that, in the investigator's judgement will substantially increase the risk to the subject if he or she participates in the study.
- 10. Women during pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituto di Medicina Interna CIC Columbus Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore
Roma, 00168
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Single-center, Dose-finding, Pilot Study Evaluating the Efficacy of VSL#3® in the Maintenance of Clinical and Endoscopic Remission of Mild-to-moderate UC
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation limited to colonic mucosa. Its pathogenesis is not still clear, even if a multifactorial aetiology has been advocated. The aim of this study is to evaluate the long-term efficacy of two different doses of VSL#3® added on standard therapy (5-ASA) in maintaining remission in an adult population of patients with UC, compared with the standard therapy (5-ASA) plus placebo. The investigators hypothesized that adding VSL#3® to mesalamine would lead to higher remission rate at long-term evaluation.
Read the detailed description
This is a Phase II a, parallel-groups, randomized, double-blind, placebo-controlled, single-center, dose finding study in subjects with UC in remission. Two different oral doses of VSL#3® added to standard therapy (5-ASA) will be investigated compared to standard therapy (5-ASA) plus placebo (in a 1:1:1 ratio).
All patients will receive standard therapy for maintaining remission. 39 subjects will be randomly assigned to 1 of the 3 treatment arms for the 12-month treatment period as following:
- group A: 13 patients will receive mesalamine 2.4 g/day in once daily administration plus VSL#3® 450 billion sachet, two sachets per day for 12 months (900 billion of bacteria per day)
- group B: 13 patients will receive mesalamine 2.4 g/day in once daily administration plus VSL#3® 450 billion sachet, two sachets twice a day (1800 billion of bacteria per day) for 12 months
- group C: 13 patients will receive mesalamine 2.4 g/day in once daily administration plus placebo for 12 months.
Subject participation in this study will be approximately 20 months which includes up to a 8-week screening period, a 12-month treatment period, and a 6-month follow-up period. At the conclusion of the 12-month treatment period, subjects will continue in the 6-month follow-up period (telephone contact conducted after 6 months).
- Conditions
- Ulcerative Colitis
- Being tested
- VSL#3®, Mesalamine, 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.
VSL#3®Dietary supplement
VSL#3® 450 billion sachets
MesalamineDrug
Mesalamine 2.4 g/day in once daily administration.
PlaceboDrug
Also called Placebo (for VSL#3®)
sachets with maltose, cornstarch and dioxide
| Study group | Role | What they receive |
|---|---|---|
| Mesalamine plus high-probiotic preparation VSL#3® | Experimental | Mesalamine 2.4 g/day in once daily administration plus VSL#3® 450 billion sachets, two sachets per day (900 billion of bacteria per day) for 12 months. Receives: Dietary Supplement: VSL#3®; Drug: Mesalamine |
| Mesalamine plus low-probiotic preparation VSL#3® | Experimental | Mesalamine 2.4 g/day in once daily administration plus VSL#3® 450 billion sachets, two sachets twice a day (1800 billion of bacteria per day) for 12 months. Receives: Dietary Supplement: VSL#3®; Drug: Mesalamine |
| Mesalamine plus Placebo | Active comparator | Mesalamine 2.4 g/day in once daily administration plus placebo for 12 months. Receives: Drug: Mesalamine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the efficacy of VSL#3® plus standard therapy (5-ASA) in maintaining clinical and endoscopic remission in patients with UC in remission.
Proportion of subjects in clinical and endoscopic remission at month 12 as defined by Total Mayo Score ≤2 with no individual subscore>1 and rectal bleed subscore of 0.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start28 Apr 2017
- Primary completion24 Apr 2019
- Study completion24 Apr 2019
Why it stopped: Administrative reasons
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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- VSL Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Actial Farmaceutica S.r.l.
- Responsible party
- Sponsor
- Investigators
- Alessandro Armuzzi, Principal investigator, Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415711
- Sponsor's protocol ID
- CDIVSL01
- Acronym
- PROREM UC
- Status last verified
- Jan 2020
- First submitted
- 5 Jan 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Single-center, Dose-finding, Pilot Study Evaluating the Efficacy of VSL#3® in the Maintenance of Clinical and Endoscopic Remission of Mild-to-moderate UC
- ClinicalTrials.gov ID
- NCT03415711
- Acronym / sponsor ID
- PROREM UC / CDIVSL01
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative reasons
- Enrolment
- 14 participants (actual)
- Lead sponsor
- VSL PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Actial Farmaceutica S.r.l.
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 24 Apr 2019 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 30 Jan 2018 (actual)
- 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.
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) characterized by chronic inflammation limited to colonic mucosa. Its pathogenesis is not still clear, even if a multifactorial aetiology has been advocated. The aim of this study is to evaluate the long-term efficacy of two different doses of VSL#3® added on standard therapy (5-ASA) in maintaining remission in an adult population of patients with UC, compared with the standard therapy (5-ASA) plus placebo. The investigators hypothesized that adding VSL#3® to mesalamine would lead to higher remission rate at long-term evaluation.
Detailed description
This is a Phase II a, parallel-groups, randomized, double-blind, placebo-controlled, single-center, dose finding study in subjects with UC in remission. Two different oral doses of VSL#3® added to standard therapy (5-ASA) will be investigated compared to standard therapy (5-ASA) plus placebo (in a 1:1:1 ratio).
All patients will receive standard therapy for maintaining remission. 39 subjects will be randomly assigned to 1 of the 3 treatment arms for the 12-month treatment period as following:
- group A: 13 patients will receive mesalamine 2.4 g/day in once daily administration plus VSL#3® 450 billion sachet, two sachets per day for 12 months (900 billion of bacteria per day)
- group B: 13 patients will receive mesalamine 2.4 g/day in once daily administration plus VSL#3® 450 billion sachet, two sachets twice a day (1800 billion of bacteria per day) for 12 months
- group C: 13 patients will receive mesalamine 2.4 g/day in once daily administration plus placebo for 12 months.
Subject participation in this study will be approximately 20 months which includes up to a 8-week screening period, a 12-month treatment period, and a 6-month follow-up period. At the conclusion of the 12-month treatment period, subjects will continue in the 6-month follow-up period (telephone contact conducted after 6 months).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mesalamine plus high-probiotic preparation VSL#3® | Experimental | Dietary Supplement: VSL#3®, Drug: MesalamineMesalamine 2.4 g/day in once daily administration plus VSL#3® 450 billion sachets, two sachets per day (900 billion of bacteria per day) for 12 months. |
| Mesalamine plus low-probiotic preparation VSL#3® | Experimental | Dietary Supplement: VSL#3®, Drug: MesalamineMesalamine 2.4 g/day in once daily administration plus VSL#3® 450 billion sachets, two sachets twice a day (1800 billion of bacteria per day) for 12 months. |
| Mesalamine plus Placebo | Active comparator | Drug: Mesalamine, Drug: PlaceboMesalamine 2.4 g/day in once daily administration plus placebo for 12 months. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- Subjects are willing and able to participate in the study, complete subject assessments, attend scheduled clinic visits, and comply with all protocol requirements as evidenced by written informed consent.
- Male and/or female subjects aged ≥18 years at the time of informed consent.
- A diagnosis of UC for ≥3 months. A biopsy report must be available to confirm the histological diagnosis in the subject's source documentation. In addition, a report documenting disease duration and extent of disease (e.g., proctosigmoiditis, left-sided colitis and pancolitis) based upon prior colonoscopy must also be available in source documentation.
- Must have a flexible sigmoidoscopy indicative of UC in remission (Mayo endoscopic subscore ≤1) during screening period, to be performed after all other inclusion criteria have been met.
Key exclusion criteria (8 listed)
- Subjects with a diagnosis of indeterminate colitis or Crohn's disease. Subjects with clinical findings suggestive of Crohn's disease, e.g., fistulae or granulomas on biopsy are also excluded.
- Subjects with colonic dysplasia or neoplasia.
- Subjects with a history of colonic or small bowel obstruction or resection, except for appendectomy.
- Use of rectal 5-aminosalicylic acid or systemic or rectal corticosteroids within 30 days before baseline, use of immunosuppressive agents within 12 weeks before baseline.
- Use of antitumor necrosis factor (anti-TNFα) or anti-integrin therapy for UC at any moment of previous patient history 6. Repeated use of non-steroidal anti-inflammatory drugs (NSAIDs), including the non-steroidal anti-inflammatory drugs such as aspirin or ibuprofen (except for prophylactic use of a stable dose of aspirin up to 325 mg / day for cardiac disease). Occasional use of NSAIDs is permitted.
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#3®VSL#3® 450 billion sachets | Dietary supplement | Mesalamine plus high-probiotic preparation VSL#3®, Mesalamine plus low-probiotic preparation VSL#3® |
| MesalamineMesalamine 2.4 g/day in once daily administration. | Drug | Mesalamine plus Placebo, Mesalamine plus high-probiotic preparation VSL#3®, Mesalamine plus low-probiotic preparation VSL#3® |
| PlaceboAlso: Placebo (for VSL#3®)sachets with maltose, cornstarch and dioxide | Drug | Mesalamine plus Placebo |
Primary outcome
To characterize the efficacy of VSL#3® plus standard therapy (5-ASA) in maintaining clinical and endoscopic remission in patients with UC in remission.
Time frame: 12 months
Proportion of subjects in clinical and endoscopic remission at month 12 as defined by Total Mayo Score ≤2 with no individual subscore>1 and rectal bleed subscore of 0.
Results and safety
The study was stopped early (reason given: Administrative reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
Alessandro Armuzzi principal investigator
Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VSL#3® and Mesalamine in people with Ulcerative Colitis, run by VSL Pharmaceuticals at 1 site 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 14 inclusion and 8 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: stopped early, as of the sponsor's last update on 18 Jan 2020. 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 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. 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 was stopped early (reason given: Administrative reasons). 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?
To characterize the efficacy of VSL#3® plus standard therapy (5-ASA) in maintaining clinical and endoscopic remission in patients with UC in remission. (time frame: 12 months). 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 18 Jan 2020.