Patients undergoing continuous ambulatory peritoneal dialysis (CAPD) who received probiotic supplementation experienced changes in their intestinal microbiota, according to a new study published in Scientific Reports. The research, a single-center, prospective, randomized, double-blind, placebo-controlled trial, investigated the effects of Lactobacillus paracasei N1115 (LP N1115) on gut health in this population.
The study, conducted at the General Hospital of Ningxia Medical University between May 2020 and December 2022, enrolled 57 CAPD patients. Participants were randomized in a 2:1 ratio to receive either the probiotic LP N1115 or a placebo for 12 weeks. The primary endpoint was the change in gut microbiota diversity, abundance, and composition, as well as fecal short-chain fatty acid (SCFA) levels. Secondary endpoints included serological indices and Gastrointestinal Symptom Rating Scale (GSRS) scores.
The probiotic group received two bags per day of N1115 ready-to-eat lactic acid bacteria from Junlebao Dairy Group Co., Ltd., containing fructooligosaccharide (FOS) and LP N1115 (Lactobacillus paracasei N1115, additive amount > 3 × 10^10 CFU/bag). The placebo group received a similar product containing only pregelatinized starch and lactose. Patients maintained their usual diet and routine treatment throughout the intervention period.
Impact on Gut Microbiota
The study found that probiotic supplementation altered the diversity, abundance, and composition of gut microbiota in CAPD patients. However, the researchers noted that the probiotic treatment did not significantly change fecal SCFA levels. Specifically, the analysis of the gut microbiota composition revealed shifts in the relative abundance of different bacterial groups following the probiotic intervention.
Safety and Tolerability
Lactobacillus paracasei N1115 is included in the List of Bacteria that Can be Used in Food by the Ministry of Health of China and has been shown to be safe for consumption in various populations. The current study supports this safety profile in CAPD patients, with no serious adverse events reported during the 12-week intervention.
Study Design and Methods
The study adhered to the Declaration of Helsinki and was approved by the Ethics Committee of Ningxia Medical University General Hospital. The randomization was conducted using SPSS23.0 software. Stool samples were collected before and after the intervention, and the V3-V4 region of bacterial DNA was amplified by PCR for high-throughput sequencing. Bioinformatics analysis was performed to determine species composition and diversity.
Limitations
The authors acknowledge that estimating the effect size in microbial community research is challenging, which impacted sample size calculation. The sample size was determined based on previous studies on the gut microbiota of PD patients with a sample size of approximately 5–150, as well as factors such as previous research experience, time period, investigator dropout rate, and tolerance. A total of 57 PD patients were included in this study, including 38 in the PR group and 19 in the PL group.
