CompletedPhase 1/2

Lactobacillus Rhamnosus GG (ATCC 53103) in Mild-moderately Active UC Patients

Italy76 participantsStarted 2019-09-30

Plain-language summary

This study is a randomized double-blind clinical trial that intends to evaluate the efficacy and safety of LGG administration at two different doses, for 1 month, in ulcerative colitis (UC) patients with mild-moderate disease activity in therapy with oral mesalamine. Efficacy of therapy will be evaluated by clinical (Clinical Mayo score, quality of life assessment), endoscopic (Endoscopic Mayo score), histological, biochemical (white cell count, C-reactive protein), and molecular (mucosal colonization of the bacteria, pro- and anti-inflammatory cytokines measurement) parameters. UC patients with mild-moderately active disease despite oral treatment with mesalamine will be assessed at baseline for clinical, endoscopic, histologic inflammatory activity. After a wash-out period of 4 weeks of mesalamine, patients will be randomized to assume a regular (LGG 1.2 × 10\^10 Colony Forming Units (CFU)/day, 2 capsules a day) or a double (LGG 2.4 × 10\^10 CFU/day, 4 capsules a day) dose of LGG for 1 month. At the end of the treatment, clinical, endoscopic, and histologic inflammatory activity will be evaluated and compared to pre-treatment data. Adhesion and molecular effect of LGG will be also evaluated. Safety will be assessed by weekly phone calls and with direct physical examination at the end of the study period.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline Clinical Mayo Score after treatment [Efficacy]

Timeframe: 1 month

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Timeframe: every week, through 1 month

Trial details

NCT IDNCT04102852

SponsorSan Giovanni Addolorata Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-31

View on ClinicalTrials.gov More Ulcerative Colitis Chronic Mild trials