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

NCT04102852 | Completed Phase 1

• 1 other identifier: LGG/UC/001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis Chronic Mild; Ulcerative Colitis Chronic Moderate

Keywords

probiotic; Lactobacillus rhamnosus GG; ATCC 53103; cytokines; adhesion

Outcome Measures

Primary Outcomes (2)

• Change from baseline Clinical Mayo Score after treatment [Efficacy]

  Improvement of clinical inflammatory activity (Clinical Response) evaluated by reduction of Clinical Mayo Score at the end of the treatment comparing to pre-treatment value

  1 month

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

  Recording and description of any side effect possibly related to probiotic administration

  every week, through 1 month

Secondary Outcomes (2)

• Mucosal Adhesion of LGG to Colonic Mucosa

  1 month

• Quality of Life Improvement

  1 month

Study Arms (2)

LGG regular dose

EXPERIMENTAL

Patients taking LGG 1.2 × 10\^10 CFU/day, 2 capsules a day, for 1 month

Dietary Supplement: Lactobacillus rhamnosus GG ATCC 53103

LGG double dose

EXPERIMENTAL

Patients taking LGG 2.4 × 10\^10 CFU/day, 4 capsules a day, for 1 month

Dietary Supplement: Lactobacillus rhamnosus GG ATCC 53103

Interventions

Lactobacillus rhamnosus GG ATCC 53103 DIETARY_SUPPLEMENT

probiotic administration at two different doses for 1 month

LGG double dose; LGG regular dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• San Giovanni Addolorata Hospital: lead
• Onlus S. Andrea: collaborator

Study Sites (1)

S. Giovanni Addolorata Hospital

Roma, 00184, Italy

Location

Related Publications (4)

• Pagnini C, Corleto VD, Martorelli M, Lanini C, D'Ambra G, Di Giulio E, Delle Fave G. Mucosal adhesion and anti-inflammatory effects of Lactobacillus rhamnosus GG in the human colonic mucosa: A proof-of-concept study. World J Gastroenterol. 2018 Nov 7;24(41):4652-4662. doi: 10.3748/wjg.v24.i41.4652.

  PMID: 30416313 RESULT

• Pagnini C, Martorelli M, Lanini C, Delle Fave G. Development of an Ex Vivo Organ Culture Technique to Evaluate Probiotic Utilization in IBD. J Clin Gastroenterol. 2016 Nov/Dec;50 Suppl 2, Proceedings from the 8th Probiotics, Prebiotics & New Foods for Microbiota and Human Health meeting held in Rome, Italy on September 13-15, 2015:S179-S182. doi: 10.1097/MCG.0000000000000698.

  PMID: 27741170 RESULT

• Derwa Y, Gracie DJ, Hamlin PJ, Ford AC. Systematic review with meta-analysis: the efficacy of probiotics in inflammatory bowel disease. Aliment Pharmacol Ther. 2017 Aug;46(4):389-400. doi: 10.1111/apt.14203. Epub 2017 Jun 27.

  PMID: 28653751 RESULT

• Pagnini C, Di Paolo MC, Urgesi R, Pallotta L, Fanello G, Graziani MG, Delle Fave G. Safety and Potential Role of Lactobacillus rhamnosus GG Administration as Monotherapy in Ulcerative Colitis Patients with Mild-Moderate Clinical Activity. Microorganisms. 2023 May 24;11(6):1381. doi: 10.3390/microorganisms11061381.

  PMID: 37374884 DERIVED

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cristiano Pagnini, MD, PhD

  S.Giovanni Addolorata Hospital

  PRINCIPAL INVESTIGATOR

• Gianfranco Delle Fave, MD

  Onlus S. Andrea

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients do not know if the LGG dose they a taking is the "regular" ot the "double" dose The investigator that assess the parameters at the end of the treatment is different from the investigator that examined the patient at the pre-treatment visit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 25, 2019
• Study Start: September 30, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)