PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03415711
• Date of registration: 05/01/2018
• Prospective Registration: No
• Primary sponsor: VSL Pharmaceuticals
• Public title: PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis PROREM UC
• Scientific 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
• Date of first enrolment: April 28, 2017
• Target sample size: 14
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03415711
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Italy

Contacts

• Name: Alessandro Armuzzi
• Affiliation: Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore

Key inclusion & exclusion criteria

Inclusion Criteria:

1. 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.

2. 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.

3. Male and/or female subjects aged =18 years at the time of informed consent.

4. 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.

5. 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.

6. Must have history of previous mild-to-moderate active disease beyond the rectum (>15
cm from the anal verge).

7. Must have UC in remission with a Total Mayo Score =2 with no individual subscore>1 and
rectal bleed subscore of 0.

8. 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.

9. 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).

Exclusion Criteria:

1. 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.

2. Subjects with colonic dysplasia or neoplasia.

3. Subjects with a history of colonic or small bowel obstruction or resection, except for
appendectomy.

4. 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.

5. Use of antitumor necrosis factor (anti-TNFa) 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.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Dietary Supplement: VSL#3®

Drug: Mesalamine

Drug: Placebo

Primary Outcome(s)

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]

Secondary ID(s)

CDIVSL01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Actial Farmaceutica S.r.l.