Lactiplantibacillus plantarum P9 for chronic diarrhea in young adults: a large double-blind, randomized, placebo-controlled trial
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ABSTRACT:
INSTRUMENT(S): TripleTOF 6600
ORGANISM(S): Homo Sapiens (ncbitaxon:9606)
SUBMITTER: 
Yang Ni
PROVIDER: MSV000095296 | MassIVE | Wed Jul 10 23:25:00 BST 2024
REPOSITORIES: MassIVE
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Project description:Fecal untargeted metabolome analysis of patients with chronic diarrhea.
2024-07-10 | MSV000095296 | GNPS
Project description:Current treatments for chronic diarrhea have limited efficacy and several side effects. Probiotics have the potential to alleviate symptoms of diarrhea. This randomized, double-blind, placebo-controlled trial evaluates the effects of administering the probiotic Lactiplantibacillus plantarum P9 (P9) strain in young adults with chronic diarrhea (Clinical Trial Registration Number: ChiCTR2000038410). The intervention period lasts for 28 days, followed by a 14-day post-intervention period. Participants are randomized into the P9 (n = 93) and placebo (n = 96) groups, with 170 individuals completing the double-blind intervention phase (n = 85 per group). The primary endpoint is the diarrhea symptom severity score. Both intention-to-treat (n = 189) and per-protocol (n = 170) analyses reveal a modest yet statistically significant reduction in diarrhea severity compared to the placebo group (20.0%, P = 0.050; 21.4%, P = 0.048, respectively). In conclusion, the results of this study support the use of probiotics in managing chronic diarrhea in young adults. However, the lack of blood parameter assessment and the short intervention period represent limitations of this study.
| S-EPMC11315937 | biostudies-literature
Project description:The gut microbiota has been implicated in obesity and cardiometabolic diseases, although evidence in humans is scarce. We investigated how gut microbiota manipulation by antibiotics (7-day administration of amoxicillin, vancomycin, or placebo) affects host metabolism in 57 obese, prediabetic men. Vancomycin, but not amoxicillin, decreased bacterial diversity and reduced Firmicutes involved in short-chain fatty acid and bile acid metabolism, concomitant with altered plasma and/or fecal metabolite concentrations. Adipose tissue gene expression of oxidative pathways was upregulated by antibiotics, whereas immune-related pathways were downregulated by vancomycin. Antibiotics did not affect tissue-specific insulin sensitivity, energy/substrate metabolism, postprandial hormones and metabolites, systemic inflammation, gut permeability, and adipocyte size. Importantly, energy harvest, adipocyte size, and whole-body insulin sensitivity were not altered at 8-week follow-up, despite a still considerably altered microbial composition, indicating that interference with adult microbiota by 7-day antibiotic treatment has no clinically relevant impact on metabolic health in obese humans. This randomized, placebo-controlled, double-blind study had a 3-armed parallel design. Overweight/obese participants were randomized to oral intake of amoxicillin, vancomycin or placebo for 7 consecutive days. After an overnight fast, subcutaneous adipose tissue biopsies were taken that were subjected to gene expression profiling by array.
2016-07-15 | E-GEOD-76003 | biostudies-arrayexpress
Project description:The gut microbiota has been implicated in obesity and cardiometabolic diseases, although evidence in humans is scarce. We investigated how gut microbiota manipulation by antibiotics (7-day administration of amoxicillin, vancomycin, or placebo) affects host metabolism in 57 obese, prediabetic men. Vancomycin, but not amoxicillin, decreased bacterial diversity and reduced Firmicutes involved in short-chain fatty acid and bile acid metabolism, concomitant with altered plasma and/or fecal metabolite concentrations. Adipose tissue gene expression of oxidative pathways was upregulated by antibiotics, whereas immune-related pathways were downregulated by vancomycin. Antibiotics did not affect tissue-specific insulin sensitivity, energy/substrate metabolism, postprandial hormones and metabolites, systemic inflammation, gut permeability, and adipocyte size. Importantly, energy harvest, adipocyte size, and whole-body insulin sensitivity were not altered at 8-week follow-up, despite a still considerably altered microbial composition, indicating that interference with adult microbiota by 7-day antibiotic treatment has no clinically relevant impact on metabolic health in obese humans.
2016-07-15 | GSE76003 | GEO
Project description:BackgroundNon-nutritive sweeteners (NNS) are widely consumed by humans due to their apparent innocuity, especially sucralose. However, several studies link sucralose consumption to weight gain and metabolic derangements, although data are still contradictory.ObjectiveTo determine the effect of acute and chronic consumption of sucralose on insulin and glucose profiles in young healthy adults.Material and methodsThis was a randomized, parallel, double-blind, placebo-controlled trial conducted in healthy young adults from 18 to 35 years old, without insulin resistance. A hundred thirty seven participants were randomized into three groups: a) volunteers receiving 48 mg sucralose, b) volunteers receiving 96 mg sucralose, and c) controls receiving water as placebo. All participants underwent a 3-h oral glucose tolerance test (OGTT) preceded by consuming sucralose or placebo 15 min before glucose load, at two time points: week zero (Wk0) and week ten (Wk10). Serum insulin and glucose were measured every 15 min during both OGTTs.ResultsCompared to Wk0, consumption of sucralose for 10 weeks provoked 1) increased insulin concentrations at 0 min (7.5 ± 3.4 vs 8.8 ± 4.1 μIU/mL; p = 0.01), 30 min (91.3 ± 56.2 vs 110.1 ± 49.4 μIU/mL; p = 0.05), 105 min (47.7 ± 24.4 vs 64.3 ± 48.2 μIU/mL; p = 0.04) and 120 min (44.8 ± 22.1 vs 63.1 ± 47.8 μIU/mL; p = 0.01) in the 48 mg sucralose group; 2) increased blood glucose at - 15 min (87.9 ± 4.6 vs 91.4 ± 5.4 mg/dL; p = 0.003), 0 min (88.7 ± 4 vs 91.3 ± 6 mg/dL; p = 0.04) and 120 min (95.2 ± 23.7 vs 106.9 ± 19.5 mg/dL; p = 0.009) in the 48 mg sucralose group; 3) increased area under the curve (AUC) of insulin in both 48 and 96 mg sucralose groups (9262 vs 11,398; p = 0.02 and 6962 vs 8394; p = 0.12, respectively); and 4) reduced Matsuda index in the 48 mg sucralose group (6.04 ± 3.19 vs 4.86 ± 2.13; p = 0.01).ConclusionsThese data show that chronic consumption of sucralose can affect insulin and glucose responses in non-insulin resistant healthy young adults with normal body mass index (between 18.5 and 24.9 kg/m2), however, the effects are not consistent with dose; further research is required.Clinical trial registryNCT03703141.
| S-EPMC7155288 | biostudies-literature
Project description:BackgroundAttentional bias to pain-related information has been implicated in pain chronicity. To date, research investigating attentional bias modification training (ABMT) procedures in people with chronic pain has found variable success, perhaps because training paradigms are typically repetitive and monotonous, which could negatively affect engagement and adherence. Increasing engagement through the gamification (ie, the use of game elements) of ABMT may provide the opportunity to overcome some of these barriers. However, ABMT studies applied to the chronic pain field have not yet incorporated gamification elements.ObjectiveThis study aimed to investigate the effects of a gamified web-delivered ABMT intervention in a sample of adults with chronic pain via a randomized, double-blind, placebo-controlled trial.MethodsA final sample of 129 adults with chronic musculoskeletal pain, recruited from clinical (hospital outpatient waiting list) and nonclinical (wider community) settings, were included in this randomized, double-blind, placebo-controlled, 3-arm trial. Participants were randomly assigned to complete 6 web-based sessions of nongamified standard ABMT (n=43), gamified ABMT (n=41), or a control condition (nongamified sham ABMT; n=45) over a period of 3 weeks. Active ABMT conditions trained attention away from pain-related words. The gamified task included a combination of 5 game elements. Participant outcomes were assessed before training, during training, immediately after training, and at 1-month follow-up. Primary outcomes included self-reported and behavioral engagement, pain intensity, and pain interference. Secondary outcomes included anxiety, depression, cognitive biases, and perceived improvement.ResultsResults of the linear mixed model analyses suggest that across all conditions, there was an overall small to medium decline in self-reported task-related engagement between sessions 1 and 2 (P<.001; Cohen d=0.257; 95% CI 0.13-0.39), sessions 1 and 3 (P<.001; Cohen d=0.368; 95% CI 0.23-0.50), sessions 1 and 4 (P<.001; Cohen d=0.473; 95% CI 0.34-0.61), sessions 1 and 5 (P<.001; Cohen d=0.488; 95% CI 0.35-0.63), and sessions 1 and 6 (P<.001; Cohen d=0.596; 95% CI 0.46-0.73). There was also an overall small decrease in depressive symptoms from baseline to posttraining assessment (P=.007; Cohen d=0.180; 95% CI 0.05-0.31) and in pain intensity (P=.008; Cohen d=0.180; 95% CI 0.05-0.31) and pain interference (P<.001; Cohen d=0.237; 95% CI 0.10-0.37) from baseline to follow-up assessment. However, no differential effects were observed over time between the 3 conditions on measures of engagement, pain intensity, pain interference, attentional bias, anxiety, depression, interpretation bias, or perceived improvement (all P values>.05).ConclusionsThese findings suggest that gamification, in this context, was not effective at enhancing engagement, and they do not support the widespread clinical use of web-delivered ABMT in treating individuals with chronic musculoskeletal pain. The implications of these findings are discussed, and future directions for research are suggested.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000803998; https://anzctr.org.au/ACTRN12620000803998.aspx.International registered report identifier (irrid)RR2-10.2196/32359.
| S-EPMC11783034 | biostudies-literature
Project description:Untargeted metabolome analysis of foods in Japan
| PRJDB13827 | ENA
Project description:Introduction: There is increasing evidence that consumption of cocoa products have a beneficial effect on cardio-metabolic health, but the underlying mechanisms remain unclear. Cocoa contains a complex mixture of flavan-3-ols. Epicatechin, a major monomeric flavan-3-ol, is considered to contribute to the cardio-protective effects of cocoa. We investigated effects of pure epicatechin supplementation on whole genome gene expression profiles of circulating immune cells. Methods: In a randomized, double blind, placebo-controlled cross-over trial, 37 (pre)hypertensive (40-80y) subjects received two 4-week interventions; epicatechin (100mg/day) or placebo with a wash-out period of 4-week between both interventions. Whole genome gene expression profiles of peripheral blood mononuclear cells were determined before and after both interventions. Results: After epicatechin supplementation 1180 genes were significantly regulated, of which 234 were also significantly regulated compared to placebo. Epicatechin supplementation up-regulated gene sets involved in transcription/translation and tubulin folding and down-regulated gene sets involved in inflammation. Only a few genes within these regulated gene sets were actually significantly changed upon epicatechin supplementation. Upstream regulators that were shown to be inhibited were classified as cytokine or inflammatory type molecules. Conclusion: Pure epicatechin supplementation modestly reduced gene expression related to inflammation signalling routes in circulating immune cells. These routes are known to play a role in cardiovascular health
2018-04-25 | GSE84453 | GEO
Project description:BackgroundMultisite pain, including low-back and knee pain, is a major health issue that greatly decreases quality of life.ObjectivesThis study analyzed the effects of l-serine, which provides necessary components for nerve function, and EPA, which exerts anti-inflammatory properties, on pain scores of adults with pain in at least the low back and knee for ≥3 mo.MethodsThis was a randomized, double-blind, placebo-controlled, parallel-group study. The Japan Low Back Pain Evaluation Questionnaire (JLEQ) and Japanese Knee Osteoarthritis Measure (JKOM) were applied as primary outcomes. The Brief Pain Inventory (BPI) and safety evaluation were secondary outcomes. We enrolled 120 participants aged ≥20 y (36 men and 84 women: mean ± SD age = 40.8 ± 10.9 y). The participants were randomly allocated to either the active group (daily ingestion of 594 mg l-serine and 149 mg EPA) or placebo group. The study period consisted of 8-wk dosing and 4-wk posttreatment observation. ANCOVA between groups for each time point was conducted using the baseline scores as covariates.ResultsThe JLEQ scores (active compared with placebo: 14.2 ± 11.2 compared with 19.0 ± 10.2) at week 8 were lower in the active group (P < 0.001). The JKOM scores at week 4 (11.7 ± 9.0 compared with 13.9 ± 7.9), week 8 (10.4 ± 7.9 compared with 13.1 ± 7.1), and week 12 (10.3 ± 7.4 compared with 13.8 ± 7.5) were lower in the active group (P ≤ 0.04). Additionally, the active group had 11-27% better scores compared with the placebo group for BPI1 (worst pain), BPI3 (average pain), and BPI5D (pain during moving) at week 4 (P ≤ 0.028) and week 8 (P ≤ 0.019), respectively, and BPI5D was 23% better in the active group at week 12 (P = 0.007). No adverse events were observed.Conclusionsl-Serine and EPA were effective for pain relief in adults with low-back and knee pain after multiplicity adjustment.This trial was registered at the University Hospital Medical Information Network Clinical Trials Registry as UMIN000035056.
| S-EPMC7467851 | biostudies-literature