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Lactobacillus rhamnosus GG administration is effective and safe to induce remission in ulcerative colitis-affected people having mild-moderate clinical activity.
In individuals with ulcerative colitis, the administration of Lactobacillus rhamnosus GG (LGG, probiotics) alone seems to be a safe and viable choice for inducing remission, as deciphered from a recent open randomized clinical trial. The objective was to examine the safety and effectiveness of administering LGG as a sole treatment, at two varying doses, for ulcerative colitis management.
People with mild to moderate disease activity in ulcerative colitis (with a Partial Mayo score of ≥ 2) who did not respond to oral mesalamine treatment were eligible for inclusion in the study. These patients discontinued oral mesalamine and were observed for one month before being randomly assigned to receive an LGG supplement at a dosage of either 1.2 or 2.4 × 1010 CFU/day for a month. When the study concluded, an assessment and comparison of the clinical activity was done at the end of the study to that observed at the beginning (efficacy). Any adverse events that occurred were also monitored (safety).
The clinical improvement, measured by a reduction in the Partial Mayo score, and the absence of any serious adverse events were the major outcomes ascertained. The secondary endpoints included comparing the effectiveness and safety profiles of the 2 different doses of LGG. Patients who experienced disease flares during the study were excluded and resumed standard therapy. Both per-protocol (PP) and intention-to-treat (ITT) assessments were utilized to assess the effectiveness of the data.
Among the initial 76 patients enrolled in the study, 75 proceeded with probiotic therapy. When analyzed using the ITT approach, 42% (32 out of 76) of the patients exhibited a positive response to the treatment, 28% (21 out of 76) remained stable, and 30% (23 out of 76) experienced a deterioration in their clinical condition. Out of 72% (n=55) subjects who completed the treatment and were included in the per-protocol (PP) analysis, 58% (32 out of 55) demonstrated a clinical response, 38% (21 out of 55) remained stable, and 4% (2 out of 55) experienced a slight deterioration in their clinical condition.
Overall, 37% of the subjects achieved remission of the disease. There were no reports of severe adverse events, and only one patient discontinued the therapy because of persistent constipation. There were no discernible differences in safety and clinical effectiveness between the groups receiving various doses of LGG. This prospective study provided novel evidence that using LGG as a standalone treatment is promising for remission induction among people with ulcerative colitis.
Microorganisms
Safety and Potential Role of Lactobacillus rhamnosus GG Administration as Monotherapy in Ulcerative Colitis Patients with Mild–Moderate Clinical Activity
Cristiano Pagnini et al.
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