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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 November 2022 |
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Main ID: |
NCT04102852 |
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Date of registration:
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17/09/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Lactobacillus Rhamnosus GG (ATCC 53103) in Mild-moderately Active UC Patients
LGGinUC |
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Scientific title:
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The Role of Lactobacillus Rhamnosus GG (ATCC 53103) in the Modulation of the Inflammatory Process in the Mucosa of Ulcerative Colitis (UC) Patients With Mild-moderate Clinical Activity |
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Date of first enrolment:
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September 30, 2019 |
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Target sample size:
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76 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT04102852 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Italy
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Contacts
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Name:
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Cristiano Pagnini, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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S.Giovanni Addolorata Hospital |
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Name:
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Gianfranco Delle Fave, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Onlus S. Andrea |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- firm diagnosis of UC (clinical, endoscopic and histological criteria) from at least 1
year
- mild-moderate clinical activity (Clinical Mayo score 2-4)
- patient taking oral mesalamine
- Informed consent obtained and signed at the screening visit (T-1)
Exclusion Criteria:
- Pregnant women
- Serious co-morbidities (i.e. autoimmune pathologies, cancer, chronic infectious
conditions, immunocompromised patients)
- Patients at first diagnosis of UC
- Patients with current immunosuppressive and/or biologic therapy for IBD, or who had
immunosuppressive and/or biologic therapy for IBD in the last year
- Patients with current oral and/or topical steroid therapy, or who had oral steroid
therapy for disease flare in the last 6 months
- Patients with current topical UC therapy (suppositories, enemas, foams)
- Patients with current antibiotic/probiotic therapy, or who had antibiotic/probiotic
therapy in the last 3 months
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis Chronic Mild
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Ulcerative Colitis Chronic Moderate
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Intervention(s)
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Dietary Supplement: Lactobacillus rhamnosus GG ATCC 53103
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Primary Outcome(s)
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Change from baseline Clinical Mayo Score after treatment [Efficacy]
[Time Frame: 1 month]
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Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
[Time Frame: every week, through 1 month]
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Secondary Outcome(s)
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Quality of Life Improvement
[Time Frame: 1 month]
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Mucosal Adhesion of LGG to Colonic Mucosa
[Time Frame: 1 month]
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Secondary ID(s)
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LGG/UC/001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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