scholarly journals Psychophysiological Effects of Lactobacillus plantarum PS128 in Patients with Major Depressive Disorder: A Preliminary 8-Week Open Trial

Nutrients ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 3731
Author(s):  
Hui-Mei Chen ◽  
Po-Hsiu Kuo ◽  
Chia-Yueh Hsu ◽  
Yi-Hung Chiu ◽  
Yen-Wenn Liu ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Sample Size ◽  
Lactobacillus Plantarum ◽  
Rating Scale ◽  
Controlled Trial ◽  
Small Sample ◽  
Open Trial ◽  
Depression Symptoms ◽  
Fatty Acid Binding ◽  
Markers Of Inflammation

Recent studies have suggested that gut–brain axis may be one of the mechanisms of major depression disorder (MDD). The current study aimed to investigate the effects of Lactobacillus plantarum PS128 (PS128) on psychophysiology in patients with MDD. We recruited 11 patients with MDD and gave them PS128 for 8 weeks. We compared depression symptoms, serum markers of inflammation and gut permeability, and gut microbiota before and after 8-week intervention and also explored the correlations among symptoms, biomarkers, and gut microbiota. After 8-week PS128 intervention, scores of Hamilton Depression Rating Scale-17 and Depression and Somatic symptoms Scale significantly decreased. Serum levels of high sensitivity c-reactive protein, interluekin-6, and tumor necrosis factor-α, zonulin and intestinal fatty acid binding protein, and the composition of gut microbiota did not significantly change after 8-week PS128 intervention. However, we found changes of some genera were correlated with changes of symptoms and biomarkers. In conclusion, this is an open trial with small sample size and has several limitations. The results need to be verified by randomized, double-blind, placebo-controlled trial with larger sample size.

Abstract 3725: Simvastatin but Not Pravastatin Affects Sleep: Findings from the UCSD Statin Study

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Beatrice A Golomb ◽  
Edwin K Kwon ◽  
Michael H Criqui ◽  
Joel E Dimsdale
Keyword(s):  
Sleep Quality ◽  
Rating Scale ◽  
Sleep Problems ◽  
Small Sample Size ◽  
Case Reports ◽  
Controlled Trial ◽  
Small Sample ◽  
T Test ◽  
Secondary Outcome ◽  
Regression Analyses

Background : Case reports have suggested possible effects of lipophilic statins on sleep in some subjects. Most randomized studies evaluating the effect of statins on sleep have had small sample size and short duration (≤ 6 weeks). Whether statins affect sleep on average, favorably or adversely, has been unclear. Goal : To assess the effects of lipophilic and hydrophilic statins on sleep. Subjects : 1016 adult men and women without diabetes or heart disease, with LDL-cholesterol 115–190mg/dL. Design : Randomized double blind placebo-controlled trial of simvastatin 20mg, pravastatin 40mg or placebo for 6 months. Sleep was a prespecified secondary outcome. It was assessed by both an adaptation of the Leeds sleep scale (a visual analog scale of sleep quality); and a rating scale of sleep problems. Both items were measured at baseline and on-treatment. Analysis : Baseline comparability of randomization groups including sleep measures was affirmed. T-test of mean on-treatment sleep scores across randomization groups was performed. This complemented regression analyses, adjusted for baseline values of the respective sleep assessment. Results : Groups were comparable at baseline on variables including both sleep measures. Simvastatin use was associated with significantly worse sleep quality, and significantly greater reported sleep problems than either pravastatin or placebo, by t-test and regression analyses. Pravastatin did not differ significantly from placebo on any sleep outcome. Conclusion : Findings were compatible with the hypothesis that statins may impair sleep in some subjects, and that this impairment may arise selectively with lipophilic statins. Table 1. Effects of Statins on Sleep: Regression Analysis

scholarly journals The Add-On Effect of Lactobacillus plantarum PS128 in Patients With Parkinson's Disease: A Pilot Study

2021 ◽  
Vol 8 ◽  
Author(s):  
Chin-Song Lu ◽  
Hsiu-Chen Chang ◽  
Yi-Hsin Weng ◽  
Chiung-Chu Chen ◽  
Yi-Shan Kuo ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Lactobacillus Plantarum ◽  
Outcome Measures ◽  
Rating Scale ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Motor Deficits ◽  
Motor Symptoms ◽  
Non Motor Symptoms

Background:Lactobacillus plantarum PS128 (PS128) is a specific probiotic, known as a psychobiotic, which has been demonstrated to alleviate motor deficits and inhibit neurodegenerative processes in Parkinson's disease (PD)-model mice. We hypothesize that it may also be beneficial to patients with PD based on the possible mechanism via the microbiome-gut-brain axis.Methods: This is an open-label, single-arm, baseline-controlled trial. The eligible participants were scheduled to take 60 billion colony-forming units of PS128 once per night for 12 weeks. Clinical assessments were conducted using the Unified Parkinson's Disease Rating Scale (UPDRS), modified Hoehn and Yahr scale, and change in patient “ON-OFF” diary recording as primary outcome measures. The non-motor symptoms questionnaire, Beck depression inventory-II, patient assessment of constipation symptom, 39-item Parkinson's Disease Questionnaire (PDQ-39), and Patient Global Impression of Change (PGI-C) were assessed as secondary outcome measures.Results: Twenty-five eligible patients (32% women) completed the study. The mean age was 61.84 ± 5.74 years (range, 52–72), mean disease duration was 10.12 ± 2.3 years (range, 5–14), and levodopa equivalent daily dosage was 1063.4 ± 209.5 mg/daily (range, 675–1,560). All patients remained on the same dosage of anti-parkinsonian and other drugs throughout the study. After 12 weeks of PS128 supplementation, the UPDRS motor scores improved significantly in both the OFF and ON states (p = 0.004 and p = 0.007, respectively). In addition, PS128 intervention significantly improved the duration of the ON period and OFF period as well as PDQ-39 values. However, no obvious effect of PS128 on non-motor symptoms of patients with PD was observed. Notably, the PGI-C scores improved in 17 patients (68%). PS128 intervention was also found to significantly reduce plasma myeloperoxidase and urine creatinine levels.Conclusion: The present study demonstrated that PS128 supplementation for 12 weeks with constant anti-parkinsonian medication improved the UPDRS motor score and quality of life of PD patients. We suggest that PS128 could serve as a therapeutic adjuvant for the treatment of PD. In the future, placebo-controlled studies are needed to further support the efficacy of PS128 supplementation.Clinical Trial Registration:https://clinicaltrials.gov/, identifier: NCT04389762.

scholarly journals An Almond-Based Low Carbohydrate Diet Improves Depression and Glycometabolism in Patients with Type 2 Diabetes through Modulating Gut Microbiota and GLP-1: A Randomized Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 3036
Author(s):  
Mengxiao Ren ◽  
Huaiyu Zhang ◽  
Jindan Qi ◽  
Anni Hu ◽  
Qing Jiang ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Gut Microbiota ◽  
Controlled Trial ◽  
Glycosylated Hemoglobin ◽  
Depression Symptoms ◽  
Carbohydrate Diet ◽  
Low Carbohydrate Diet ◽  
Randomized Controlled

Background: Alow carbohydrate diet (LCD) is more beneficial for the glycometabolism in type 2 diabetes (T2DM) and may be effective in reducing depression. Almond, which is a common nut, has been shown to effectively improve hyperglycemia and depression symptoms. This study aimed to determine the effect of an almond-based LCD (a-LCD) on depression and glycometabolism, as well as gut microbiota and fasting glucagon-like peptide 1 (GLP-1) in patients with T2DM. Methods: This was a randomized controlled trial which compared an a-LCD with a low-fat diet (LFD). Forty-five participants with T2DM at a diabetes club and the Endocrine Division of the First and Second Affiliated Hospital of Soochow University between December 2018 to December 2019 completed each dietary intervention for 3 months, including 22 in the a-LCD group and 23 in the LFD group. The indicators for depression and biochemical indicators including glycosylated hemoglobin (HbA1c), gut microbiota, and GLP-1 concentration were assessed at the baseline and third month and compared between the two groups. Results: A-LCD significantly improved depression and HbA1c (p < 0.01). Meanwhile, a-LCD significantly increased the short chain fatty acid (SCFAs)-producing bacteria Roseburia, Ruminococcus and Eubacterium. The GLP-1 concentration in the a-LCD group was higher than that in the LFD group (p < 0.05). Conclusions: A-LCD could exert a beneficial effect on depression and glycometabolism in patients with T2DM. We speculate that the role of a-LCD in improving depression in patients with T2DM may be associated with it stimulating the growth of SCFAs-producing bacteria, increasing SCFAs production and GPR43 activation, and further maintaining GLP-1 secretion. In future studies, the SCFAs and GPR43 activation should be further examined.

A Pilot Randomized Sham-Controlled Trial of MC5-A Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN)

2019 ◽  
Vol 35 (1) ◽  
pp. 53-58 ◽  
Author(s):  
Thomas J. Smith ◽  
A. Rab Razzak ◽  
Amanda L. Blackford ◽  
Jennifer Ensminger ◽  
Catherine Saiki ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Rating Scale ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Brief Pain Inventory ◽  
Small Sample ◽  
Sham Treatment ◽  
The Real ◽  
Average Pain ◽  
Scrambler Therapy

Background: Chemotherapy-induced peripheral neuropathy (CIPN) affects 30% to 40% of patients with cancer with long-lasting disability. Scrambler therapy (ST) appeared to benefit patients in uncontrolled trials, so we performed a randomized sham-controlled Phase II trial of ST. Methods: The primary end point was “average pain” after 28 days on the Numeric Rating Scale. Each received ten 30-minute sessions of ST on the dermatomes above the painful areas, or sham treatment on the back, typically at L3-5 where the nerve roots would enter the spinal cord. Outcomes included the Brief Pain Inventory (BPI)-CIPN and the EORTC CIPN-20 scale. Patients were evaluated before treatment (day 0), day 10, and days 28, 60, and 90. Results: Data regarding pain as a primary outcome were collected for 33 of the 35 patients. There were no significant differences between the sham and the “real” ST group at day 10, 28, 60, or 90, for average pain, the BPI, or EORTC CIPN-20. Individual responses were noted during the ST treatment on the real arm, but most dissipated by day 30. There was improvement in the sensory subscale of the CIPN-20 at 2 months in the “real” group ( P = .14). All “real” patients wanted to continue treatment if available. Discussion: We observed no difference between sham and real ST CIPN treatment. Potential reasons include at least the following: ST does not work; the sham treatment had some effect; small sample size with heterogeneous patients; misplaced electrodes on an area of nonpainful but damaged nerves; or a combination of these factors.

scholarly journals A Randomised Controlled Trial Comparing the Effect of E-learning, with a Taught Workshop, on the Knowledge and Search Skills of Health Professionals

2006 ◽  
Vol 1 (3) ◽  
pp. 44 ◽  
Author(s):  
Nicola Pearce-Smith
Keyword(s):  
Randomised Controlled Trial ◽  
Sample Size ◽  
Health Professionals ◽  
Search Strategy ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Post Intervention ◽  
E Learning ◽  
Randomised Controlled

Objective - The aim of the trial was to establish whether there is a significant difference in terms of knowledge and skills, between self-directed learning using a web-based resource, compared with a classroom based interactive workshop, for teaching health professionals how to search. The outcomes measured were knowledge of databases and study designs, and search skills. Methods - The study design was a randomised controlled trial (RCT). 17 health professionals were randomised into one of two groups – one group (EG) received access to a search-skills web resource, and the other group received a search workshop (WG) taught by a librarian. Participants completed pre- and post-intervention tests involving multiple choice questions and practical searching using clinical scenarios.. Results - 9 WG and 6 EG participants completed both pre-and post-intervention tests. The test results were blindly marked using a score chart developed with two other librarians. For question formulation and devising a search strategy, all participants obtained a score that was the same or better after receiving the intervention (both WG and EG), but statistical analysis showed that the only significant outcomes were for the WG devising a search strategy (p=0.01) and preferring to search using MeSH after receiving the taught workshop (p=0.02). The Mann-Whitney test showed there were no significant differences in any of the outcomes (p>0.05), between the WG and the EG. The statistical analyses must be viewed with caution due to the small sample size. Conclusions - There were no significant differences in knowledge of databases and study design, or search skills, when the WG and the EG were compared. Although many participants obtained a score that was higher post-intervention, only devising a search strategy and preferring to search using MeSH were significant for the WG. The question of whether a taught workshop and an e-learning module are of equal effectiveness in teaching search skills, is an important one for health librarians involved in user education, and was a justifiable topic to propose and conduct research. The fact that the results are mainly inconclusive due to the small sample size is disappointing, but does not diminish the importance of conducting the study.

scholarly journals Performance of Polytomous IRT Models With Rating Scale Data: An Investigation Over Sample Size, Instrument Length, and Missing Data

2021 ◽  
Vol 6 ◽  
Author(s):  
Shenghai Dai ◽  
Thao Thu Vo ◽  
Olasunkanmi James Kehinde ◽  
Haixia He ◽  
Yu Xue ◽  
...  
Keyword(s):  
Missing Data ◽  
Sample Size ◽  
Rating Scales ◽  
Rating Scale ◽  
Small Sample Size ◽  
Small Sample ◽  
Item Parameter ◽  
Partial Credit Model ◽  
Irt Models ◽  
Polytomous Irt Models

The implementation of polytomous item response theory (IRT) models such as the graded response model (GRM) and the generalized partial credit model (GPCM) to inform instrument design and validation has been increasing across social and educational contexts where rating scales are usually used. The performance of such models has not been fully investigated and compared across conditions with common survey-specific characteristics such as short test length, small sample size, and data missingness. The purpose of the current simulation study is to inform the literature and guide the implementation of GRM and GPCM under these conditions. For item parameter estimations, results suggest a sample size of at least 300 and/or an instrument length of at least five items for both models. The performance of GPCM is stable across instrument lengths while that of GRM improves notably as the instrument length increases. For person parameters, GRM reveals more accurate estimates when the proportion of missing data is small, whereas GPCM is favored in the presence of a large amount of missingness. Further, it is not recommended to compare GRM and GPCM based on test information. Relative model fit indices (AIC, BIC, LL) might not be powerful when the sample size is less than 300 and the length is less than 5. Synthesis of the patterns of the results, as well as recommendations for the implementation of polytomous IRT models, are presented and discussed.

The inventory of depressive symptomatology is more sensitive to changes in depressive symptomatology than the hamilton depression rating scale in patients with minor depression

2011 ◽  
Vol 26 (S2) ◽  
pp. 634-634
Author(s):  
I. Helmreich ◽  
S. Wagner ◽  
R. Mergl ◽  
A.-K. Allgaier ◽  
M. Hautzinger ◽  
...  
Keyword(s):  
Rating Scales ◽  
Rating Scale ◽  
Depressive Symptomatology ◽  
Controlled Trial ◽  
Depression Symptoms ◽  
List Type ◽  
Depression Severity ◽  
Residual Symptoms ◽  
Hamilton Depression Rating Scale ◽  
Dsm Iv

BackgroundDepression rating scales play a decisive role in the assessment of the severity of depression and the evaluation of the efficacy of antidepressant treatments. The Hamilton Depression Rating Scale (HAMD) is regarded as the ‘gold standard’; nevertheless, studies suggest that the Inventory of Depressive Symptomatology (IDS) is more sensitive to detect symptom changes. The aim of the present study was to investigate whether the IDS is more sensitive in detecting changes in depression symptoms in patients with mild major, minor or subsyndromal depression (MIND).MethodsBiweekly IDS-C28 and HAMD17 data from 340 patients of a 10-week randomized, placebo-controlled trial comparing the effectiveness of sertraline and cognitive-behavioural therapy in patients with MIND were analysed. We investigated sensitivity to change for both scales1)from assessment-to-assessment,2)in relation to depression severity level, and3)in relation to DSM-IV depression criterion symptoms.ResultsThe IDS-C28 was more sensitive in detecting changes in depression symptomatology over the treatment course as well as for different severity levels, especially in patients with a low depression severity. It assesses the DSM-IV criteria more thoroughly, is better able to track the change of cognitive symptoms and to identify residual symptoms.ConclusionsBoth scales are well able to assess depressive symptomatology. However, the IDS-C28 surpasses the HAMD17 in detecting small changes especially in the core symptoms of depression. This is important for an optimal treatment by capturing early improvements, enabling prompt reactions and detecting residual symptoms.

scholarly journals Gut microbiota signature in treatment-naïve attention-deficit/hyperactivity disorder

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Vanesa Richarte ◽  
Cristina Sánchez-Mora ◽  
Montserrat Corrales ◽  
Christian Fadeuilhe ◽  
Laura Vilar-Ribó ◽  
...  
Keyword(s):  
Attention Deficit Hyperactivity Disorder ◽  
Gut Microbiota ◽  
Relative Abundance ◽  
Attention Deficit ◽  
Gut Microbiome ◽  
Rating Scale ◽  
Small Sample ◽  
Adhd Group ◽  
Healthy Controls ◽  
Hyperactivity Disorder

AbstractCompelling evidence supports alterations in gut microbial diversity, bacterial composition, and/or relative abundance of several bacterial taxa in attention-deficit/hyperactivity disorder (ADHD). However, findings for ADHD are inconsistent among studies, and specific gut microbiome signatures for the disorder remain unknown. Given that previous studies have mainly focused on the pediatric form of the disorder and involved small sample sizes, we conducted the largest study to date to compare the gastrointestinal microbiome composition in 100 medication-naïve adults with ADHD and 100 sex-matched healthy controls. We found evidence that ADHD subjects have differences in the relative abundance of several microbial taxa. At the family level, our data support a lower relative abundance of Gracilibacteraceae and higher levels of Selenomonadaceae and Veillonellaceae in adults with ADHD. In addition, the ADHD group showed higher levels of Dialister and Megamonas and lower abundance of Anaerotaenia and Gracilibacter at the genus level. All four selected genera explained 15% of the variance of ADHD, and this microbial signature achieved an overall sensitivity of 74% and a specificity of 71% for distinguishing between ADHD patients and healthy controls. We also tested whether the selected genera correlate with age, body mass index (BMI), or scores of the ADHD rating scale but found no evidence of correlation between genera relative abundance and any of the selected traits. These results are in line with recent studies supporting gut microbiome alterations in neurodevelopment disorders, but further studies are needed to elucidate the role of the gut microbiota on the ADHD across the lifespan and its contribution to the persistence of the disorder from childhood to adulthood.

The intestinal microbiota as a predictor for antidepressant treatment outcome in geriatric depression: a prospective pilot study

2021 ◽  
pp. 1-13
Author(s):  
S. Melanie Lee ◽  
Tien S. Dong ◽  
Beatrix Krause-Sorio ◽  
Prabha Siddarth ◽  
Michaela M. Milillo ◽  
...  
Keyword(s):  
Treatment Outcome ◽  
Los Angeles ◽  
Gut Microbiota ◽  
Rating Scale ◽  
Antidepressant Treatment ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
Post Treatment ◽  
Geriatric Depression ◽  
Α Diversity

ABSTRACT Objectives: (1) To investigate if gut microbiota can be a predictor of remission in geriatric depression and to identify features of the gut microbiota that is associated with remission. (2) To determine if changes in gut microbiota occur with remission in geriatric depression. Design: Secondary analysis of a parent randomized placebo-controlled trial (NCT02466958). Setting: Los Angeles, CA, USA (2016-2018) Participants: Seventeen subjects with major depressive disorder, over 60 years of age, 41.2% female. Intervention: Levomilacipran (LVM) or placebo. Measurements: Remission was defined by Hamilton Depression Rating Scale score of 6 or less at 12 weeks. 16S-ribosomal RNA sequencing based fecal microbiota composition and diversity were measured at baseline and 12 weeks. Differences in fecal microbiota were evaluated between remitters and non-remitters as well as between baseline and post-treatment samples. LVM and placebo groups were combined in all the analyses. Results: Baseline microbiota showed no community level α-diversity or β-diversity differences between remitters and non-remitters. At the individual taxa level, a random forest classifier created with nine genera from the baseline microbiota was highly accurate in predicting remission (AUC = .857). Of these, baseline enrichment of Faecalibacterium, Agathobacter and Roseburia relative to a reference frame was associated with treatment outcome of remission. Differential abundance analysis revealed significant genus level changes from baseline to post-treatment in remitters, but not in non-remitters. Conclusions: This is the first study demonstrating fecal microbiota as a potential predictor of treatment response in geriatric depression. Our findings need to be confirmed in larger prospective studies.

scholarly journals Academic Skills Groups for Middle School Children With ADHD in the Outpatient Mental Health Setting: An Open Trial

2015 ◽  
Vol 23 (4) ◽  
pp. 409-417 ◽  
Author(s):  
Heather A. Ciesielski ◽  
Leanne Tamm ◽  
Aaron J. Vaughn ◽  
Jessica E. M. Cyran ◽  
Jeffery N. Epstein
Keyword(s):  
Middle School ◽  
School Children ◽  
Rating Scale ◽  
Small Sample Size ◽  
Academic Skills ◽  
Outpatient Setting ◽  
Small Sample ◽  
Open Trial ◽  
Control Group ◽  
Middle School Children

Objective: To conduct an open trial assessing the initial efficacy of an intervention focusing on increasing skills related to academic performance (planning, organization, studying, and homework behaviors) for middle school children diagnosed with ADHD. The intervention is modeled on evidence-based interventions but designed for administration in the outpatient setting. Method: Parents and their children diagnosed with ADHD attended seven weekly group sessions targeting academic, organizational, and homework skills. Parents completed the Homework Problem Checklist and Impairment Rating Scale pre- and post-treatment. Results: Following intervention, significant improvements in homework completion and management, as well as reductions in academic impairment and improvements in parent confidence and family relations, were reported. Conclusion: Despite limitations including small sample size and lack of a control group, our results demonstrate initial efficacy of an academic skills intervention designed for use in the outpatient setting with middle school children diagnosed with ADHD on clinically relevant outcome measures.

Sign in / Sign up

Export Citation Format

Share Document