Ulcerative Colitis Chronic MildPhase 1/2LGGinUCNCT04102852
Lactobacillus Rhamnosus GG (ATCC 53103) in Mild-moderately Active UC Patients
A Phase 1/2 study testing Lactobacillus rhamnosus GG ATCC 53103 in people with Ulcerative Colitis Chronic Mild and Ulcerative Colitis Chronic Moderate, run by San Giovanni Addolorata Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate
- What is being tested?
- Lactobacillus rhamnosus GG ATCC 53103
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteItaly
- Study dates
- 30 Sep 2019to 31 Jan 2022
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Probiotic bacteria have been proposed as therapeutic option in several pathologic conditions, but their utilization is often not evidence-based driven. In inflammatory bowel disease (IBD), consistent heterogenity exists among published clinical studies. Aim of the present clinical study is to evaluate the effect of Lactobacillus rhamnosus GG (LGG), the probiotic bacteria most extensively investigated, with solid safety data and proven anti-inflammatory effect in experimental models, in ulcerative colitis (UC) patients, with a rigorous methodology, a well defined protocol, and with relevant outcomes clearly set.
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 UC patients with mild-moderate disease activity in therapy with oral mesalamine.The eligible patients will be identified by a screening visit (T-1), with consideration of inclusion and exclusion criteria, and informed consent will be signed. Then the patients will have a 4 weeks wash-out period, when oral mesalamine will be suspended, and biochemical tests [total blood count, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and serum protein electrophoresis], and endoscopic examination with biopsies will be performed. The patients will be then evaluated again prior to the randomization to regular or double dose group (T0), and clinical activity and quality of life will be assessed. Patients will be randomized to assume a regular (LGG 1.2 × 10^10 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. After 4 weeks of treatment, patients will be re-evaluated (T1), with physical examination and interview, and rectum-sigmoidoscopy with biopsies will be performed. The patients will then be allowed to assume the therapy they were taking at T-1 visit (mesalamine), and will be assessed for the last time after 4 weeks after treatment completition (T2), with physical examination and interview. Efficacy of therapy will be evaluated by comparison of clinical, endoscopic, histological, biochemical and molecular data, pre- and post-treatment (T1 vs. T0). Randomization of patients in the groups will be performed by a computer-generated randomization list, in a double blind fashion. Clinical activity will be evaluated by Clinical Mayo Score calculation. Quality of life will be evaluated by specific validated tests. Endoscopic activity will be evaluated by Endoscopic Mayo Score calculation, by an endoscopist blinded to clinical data of patients. Histologic activity will be evaluated by expert anatomopathologists, by means of Geboes score. Molecular activity of LGG will be evaluated by assessment of bacteria adhesion to the colonic mucosa, measured by real-time(RT)-Polymerase Chain Reaction (PCR) with specific primers on total DNA extracted by bioptic samples (as already described), and by quantification of expression of pro- and anti-inflammatory cytokines, before and after probiotic treatment, by means of RT-PCR on total RNA extracted from bioptic samples (as already described).
Safety of LGG treatment will be assessed by weekly phone calls to the patients, in order to investigate the unexpected occurence of side-effects, and with direct physical examination and biochemical tests at the end of the study period (T1). Possible LGG translocation will be evaluated by RT-PCR with specific primers on total DNA extracted from peripheral blood collected from patients at the end of treatment (T1).
- Being tested
- Lactobacillus rhamnosus GG ATCC 53103
- Keywords
- probiotic, Lactobacillus rhamnosus GG, ATCC 53103, cytokines, adhesion
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus GG ATCC 53103Dietary supplement
probiotic administration at two different doses for 1 month
| Study group | Role | What they receive |
|---|---|---|
| LGG regular dose | Experimental | Patients taking LGG 1.2 × 10^10 CFU/day, 2 capsules a day, for 1 month Receives: 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 Receives: Dietary Supplement: Lactobacillus rhamnosus GG ATCC 53103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Recording and description of any side effect possibly related to probiotic administration
Measured: every week, through 1 month
Secondary outcomes (2)
Mucosal Adhesion of LGG to Colonic Mucosa
Effective LGG colonization in colonic mucosa as measured by real-time PCR detection of LGG in bioptic samples of colon of LGG treated patients at the end of the treatment
Measured: 1 month
Quality of Life Improvement
Improvement of QoL parameters as measured and assessed by Short Form-36 Health Survey (SF-36), before and after probiotic treatment. The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state. The final score is generated by a formula that combines the different domains' score, and expressed by a score with a 0 to 100 range,with a higher score defining a more favorable health state
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start30 Sep 2019
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis Chronic MildStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Giovanni Addolorata Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Onlus S. Andrea
- Responsible party
- Principal investigator, Cristiano Pagnini, San Giovanni Addolorata Hospital
- Investigators
- Cristiano Pagnini, MD, PhD, Principal investigator, S.Giovanni Addolorata HospitalGianfranco Delle Fave, MD, Study director, Onlus S. Andrea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102852
- Sponsor's protocol ID
- LGG/UC/001
- Acronym
- LGGinUC
- Status last verified
- Oct 2022
- First submitted
- 17 Sep 2019
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30416313Pagnini 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.
PubMed 27741170Derwa 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.
PubMed 28653751Pagnini 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.
PubMed 37374884
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04102852
- Acronym / sponsor ID
- LGGinUC / LGG/UC/001
- Keywords
- probiotic, Lactobacillus rhamnosus GG, ATCC 53103, cytokines, adhesion
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- San Giovanni Addolorata HospitalUniversity, hospital or other
- Collaborators
- Onlus S. Andrea
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 25 Sep 2019 (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.
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.
Detailed description
Probiotic bacteria have been proposed as therapeutic option in several pathologic conditions, but their utilization is often not evidence-based driven. In inflammatory bowel disease (IBD), consistent heterogenity exists among published clinical studies. Aim of the present clinical study is to evaluate the effect of Lactobacillus rhamnosus GG (LGG), the probiotic bacteria most extensively investigated, with solid safety data and proven anti-inflammatory effect in experimental models, in ulcerative colitis (UC) patients, with a rigorous methodology, a well defined protocol, and with relevant outcomes clearly set.
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 UC patients with mild-moderate disease activity in therapy with oral mesalamine.The eligible patients will be identified by a screening visit (T-1), with consideration of inclusion and exclusion criteria, and informed consent will be signed. Then the patients will have a 4 weeks wash-out period, when oral mesalamine will be suspended, and biochemical tests [total blood count, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and serum protein electrophoresis], and endoscopic examination with biopsies will be performed. The patients will be then evaluated again prior to the randomization to regular or double dose group (T0), and clinical activity and quality of life will be assessed. Patients will be randomized to assume a regular (LGG 1.2 × 10^10 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. After 4 weeks of treatment, patients will be re-evaluated (T1), with physical examination and interview, and rectum-sigmoidoscopy with biopsies will be performed. The patients will then be allowed to assume the therapy they were taking at T-1 visit (mesalamine), and will be assessed for the last time after 4 weeks after treatment completition (T2), with physical examination and interview. Efficacy of therapy will be evaluated by comparison of clinical, endoscopic, histological, biochemical and molecular data, pre- and post-treatment (T1 vs. T0). Randomization of patients in the groups will be performed by a computer-generated randomization list, in a double blind fashion. Clinical activity will be evaluated by Clinical Mayo Score calculation. Quality of life will be evaluated by specific validated tests. Endoscopic activity will be evaluated by Endoscopic Mayo Score calculation, by an endoscopist blinded to clinical data of patients. Histologic activity will be evaluated by expert anatomopathologists, by means of Geboes score. Molecular activity of LGG will be evaluated by assessment of bacteria adhesion to the colonic mucosa, measured by real-time(RT)-Polymerase Chain Reaction (PCR) with specific primers on total DNA extracted by bioptic samples (as already described), and by quantification of expression of pro- and anti-inflammatory cytokines, before and after probiotic treatment, by means of RT-PCR on total RNA extracted from bioptic samples (as already described).
Safety of LGG treatment will be assessed by weekly phone calls to the patients, in order to investigate the unexpected occurence of side-effects, and with direct physical examination and biochemical tests at the end of the study period (T1). Possible LGG translocation will be evaluated by RT-PCR with specific primers on total DNA extracted from peripheral blood collected from patients at the end of treatment (T1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LGG regular dose | Experimental | Dietary Supplement: Lactobacillus rhamnosus GG ATCC 53103Patients taking LGG 1.2 × 10^10 CFU/day, 2 capsules a day, for 1 month |
| LGG double dose | Experimental | Dietary Supplement: Lactobacillus rhamnosus GG ATCC 53103Patients taking LGG 2.4 × 10^10 CFU/day, 4 capsules a day, for 1 month |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Lactobacillus rhamnosus GG ATCC 53103probiotic administration at two different doses for 1 month | Dietary supplement | LGG double dose, LGG regular dose |
Primary outcome
Change from baseline Clinical Mayo Score after treatment [Efficacy]
Time frame: 1 month
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
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: every week, through 1 month
Recording and description of any side effect possibly related to probiotic administration
2 secondary outcomes
Mucosal Adhesion of LGG to Colonic Mucosa
Time frame: 1 month
Quality of Life Improvement
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Results publication: PubMed 30416313Pagnini 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.
- Results publication: PubMed 27741170Pagnini 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.
- Results publication: PubMed 28653751Derwa 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.
- Derived from this study: PubMed 37374884Pagnini 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.
- Individual participant dataSharing planned: No
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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.
Cristiano Pagnini, MD, PhD principal investigator
S.Giovanni Addolorata Hospital
Gianfranco Delle Fave, MD study director
Onlus S. Andrea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lactobacillus rhamnosus GG ATCC 53103 in people with Ulcerative Colitis Chronic Mild and Ulcerative Colitis Chronic Moderate, run by San Giovanni Addolorata Hospital 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 26 Oct 2022. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline Clinical Mayo Score after treatment [Efficacy] (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04102852, which also lists 4 linked publications.
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 26 Oct 2022.