A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of Lactiplantibacillus plantarum CJLP243 in Patients with Functional Diarrhea and High Fecal Calprotectin Levels

Abstract

Micro-inflammation in the gut, assessed by fecal calprotectin (FC), is considered a component of the pathogenesis of functional diarrhea (FD). Since probiotics may suppress micro-inflammation in the intestine by competing with harmful bacteria, we hypothesized that they would reduce the ratio of loose stool symptoms and gut inflammation in patients with FD. We conducted a double-blind, placebo-controlled trial to assess the clinical and laboratory effects of Lactobacillus plantarum CJLP243 in FD patients with elevated FC levels for two months. Twenty-four patients diagnosed with FD with elevated FC levels were randomly assigned to either a probiotic group or a placebo group. After 2 months, 10 patients in the probiotic group and 12 patients in the placebo group completed the study, and FD symptoms, FC values, and intestinal flora were re-evaluated in these subjects. The percentage of subjects who had adequate FD relief (decrease in loose stool frequency) in the probiotic group was significantly increased after two months compared with the baseline. In addition, the probiotic group showed a statistically significant decrease in log-transformed FC values compared with the pre-treatment group, whereas the placebo group showed no difference before and after the intervention. Furthermore, the levels of Leuconostoc genus organisms in the gut microbiota composition in the probiotic group increased significantly after the end of the study compared with the baseline values. In this preliminary exploratory research, we found that two months of Lactiplantibacillus plantarum CJLP243 treatment resulted in FD symptom improvement, reduced FC values, and increased Leuconostoc levels, suggesting that the intake of Lactiplantibacillus plantarum was helpful in those patients. These findings need to be validated via further clinical studies.

The Role of Gastrointestinal Microbiota in Functional Dyspepsia: A Review

“…A large number of studies have confirmed that H. pylori eradication drugs can effectively inhibit the activity of H. pylori in the gastrointestinal tract, while probiotics can effectively regulate the microbiota in the gastrointestinal tract and inhibit the growth of harmful bacteria, thus protecting the barrier function of the gastrointestinal mucosa and immune function and effectively preventing and treating the occurrence of FGIDs ( Padole et al, 2021 ; Wauters et al, 2021 ). Currently, probiotics have been widely used in the clinical treatment of FD, irritable bowel syndrome ( Moeen-Ul-Haq et al, 2022 ), functional constipation ( Kim et al, 2021 ), functional diarrhea ( Jung et al, 2022 ) and other gastrointestinal diseases, and probiotics have been effective in the clinical treatment of these FGIDs.…”

Combined probiotics with vitamin D3 supplementation improved aerobic performance and gut microbiome composition in mixed martial arts athletes

“…A similar effect was found by MinAh et al, who supplemented patients with functional diarrhea with Lactobacillus plantarum CJLP243. The authors showed that two months of intervention resulted in a reduction of fecal calprotectin concentration ( 49 ).…”

Lactiplantibacillus plantarum P9 alleviates chronic diarrhea via modulation of gut microbiota and its intestinal metabolites: a double-blind, randomized, placebo-controlled study

“…For example, a previous study found that a 4-week treatment of L. plantarum CCFM1143 decreased the defecation frequency and Bristol score in patients with chronic diarrhea 18 . Another placebo-controlled study reported that a 2-month L. plantarum CJLP243 treatment reduced loose stool frequency 20 . However, our study found that administering P9 treatment did not improve the bowel movement frequency/urgency and DASS-21 scores, which is consistent with the results reported by Bai et al (2023) 30 .…”

“…Another randomized, double-blind, placebo-controlled study found that after 8-week probiotic intervention with a multi-strain mixture of Bi dobacterium, Lactobacillus, and Streptococcus thermophilus, the total IBS-severity scoring system score reduced obviously in patients with diarrhea, although no signi cant differences were seen in the mean number of bowel movements, stool consistency, and fecal urgency between the probiotic and placebo groups 19 . Similarly, two months of L. plantarum CJLP243 administration substantially increased the proportion of patients of adequate functional diarrhea relief, with reduced loose stool frequency 20 . However, 8-week intervention probiotic fermented milk (containing L. paracasei F19, L. acidophilus La5 and B. lactis Bb12) exerted no obvious clinical effect on GI symptoms, quality of life, and psychological symptoms in IBS patients 21 .…”