scholarly journals Safety and Efficacy of Probiotic Supplementation in Reducing the Incidence of Infections and Modulating Inflammation in the Elderly with Feeding Tubes: A Pilot, Double-Blind, Placebo-Controlled Study, “IntegPRO”

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 391
Author(s):  
Paolo Orlandoni ◽  
Nikolina Jukic Peladic ◽  
Angela Amoruso ◽  
Marco Pane ◽  
Mirko Di Rosa ◽  
...  
Keyword(s):  
Nutritional Status ◽  
Statistical Significance ◽  
Intervention Group ◽  
Clinical Manifestations ◽  
Bowel Function ◽  
The Elderly ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Reactive Protein

A double-blind, placebo-controlled study was performed in a sample of geriatric patients treated with home enteral nutrition (HEN) to analyze the efficacy of a probiotic supplement Proxian®, which contains Lactiplantibacillus plantarum LP01 (LMG P-21021), Lentilactobacillus buchneri Lb26 (DSM 16341), Bifidobacterium animalis subsp. lactis BS01 (LMG P-21384), and is enriched with zinc (Zn) and selenium (Se), in reducing the incidence of infections and modulating inflammation. Thirty-two subjects were enrolled (mean age 79.7 ± 10.3 years), 16 in the intervention group, 16 controls. They received Proxian® or placebo for 60 days. Patients were assessed at baseline (t0) and 60 (t1) and 90 (t2) days after the beginning. Infections were detected by information regarding their clinical manifestations and the incidence of antibiotic therapy. Levels of C-reactive protein (CRP) were measured to study inflammation. Information on bowel function, nutritional status and testimonials regarding the feasibility of administration of the product were collected. Differences between the two groups in number of infections (25% intervention group vs. 44% controls), antibiotic therapies (12% vs. 37%) and modulation of CRP levels (median CRP moved from 0.95 mg/L (t0), to 0.6 (t1) and 0.7 (t2) in intervention group vs. 0.7 mg/L, 0.5 and 0.7 in controls) did not reach statistical significance. No significant changes in bowel function and nutritional status were found. Caregivers’ adherence was 100%. Results of this “IntegPRO” study showed that Proxian® is potentially safe, easy to administer and promising for further studies but it appears not to change the incidence of infections or modulate inflammation in elderly treated with HEN. The utility of Proxian® in reducing the incidence of infections and modulating inflammation in these subjects needs to be investigated by a larger multi-center clinical trial, and by using additional analyses on inflammatory markers and markers of infections.

Abstract 874: MLN1202, a Novel CCR2 Antagonist, Decreases C-reactive protein in Patients at Risk for Atherosclerotic Cardiovascular Disease in a Double Blind Placebo Controlled study

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
M. Davidson ◽  
J. Lekstrom-Himes ◽  
J. Gilbert ◽  
D. Donaldson ◽  
Y. Lee ◽  
...  
Keyword(s):  
At Risk ◽  
Lipid Lowering ◽  
Smoking History ◽  
Controlled Study ◽  
C Reactive Protein ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Reactive Protein ◽  
Patients At Risk ◽  
Circulating Levels

Background: Macrophages play a central role in atherosclerotic plaque formation. The CC chemokine receptor 2 (CCR2), expressed on the surface of circulating monocytes, and its ligand MCP-1 (CCL2), are present in atherosclerotic plaques and may play a critical part in endothelial monocyte recruitment and activation. MLN1202 is a humanized monoclonal antibody with high specificity to CCR2, which interrupts MCP-1 binding to CCR2. MLN1202 is being developed for the treatment of immune mediated diseases. Hypothesis: We tested the hypothesis that MLN1202 significantly influences disease activity in patients at risk for ASCVD as measured by a reduction in circulating levels of high sensitivity C-reactive protein (hsCRP), an established biomarker of inflammation. Trial Design: In this double-blind placebo controlled study patients with at least 2 or more risk factors for ASCVD, no history or symptoms of ASCVD disease, and circulating levels of hsCRP > 3mg/L, were randomized 1:1 to receive a single infusion of 10 mg/kg MLN1202 (n 56) or placebo (n = 56). Subjects with hypercholesterolemia on stable doses of lipid-lowering agents were included. Circulating levels of hsCRP were determined every 2 weeks, and clinical examination performed every 4 weeks for 16 weeks following treatment. Results and Conclusion: Patients were recruited from nine centers in the US. The study population had a mean age of 60.9 years and included subjects with hypertension (59%), hypercholesterolemia (70%), significant smoking history (28%), and type 2 diabetes (16%). At screening the median value CRP was 6.8 mg/L with interquartile range from 4.7–9.3 mg/L. PK/PD results showed that the plasma level of MLN1202 required for > 90% receptor saturation was maintained for 6 to 8 weeks. A between-group difference in reduction of hsCRP was statistically significant from week 4 through week 8 following dosing. The maximum difference in absolute median reduction was observed at week 8 and it was 1.6 mg/L (p = 0.0275; Wilcoxon); the observed median percent reduction of hsCRP was 24.2% for MLN1202 group versus 2.5% increase for placebo group at 8 weeks (p = 0.0089; Wilcoxon). These data indicate that blockade of CCR2 reduces a biomarker related to inflammation in patients at risk for ASCVD.

Co-dergocrine (Hydergine) in the treatment of tardive dyskinesia

1982 ◽  
Vol 12 (2) ◽  
pp. 427-429 ◽  
Author(s):  
Sudhir C. Rastogi ◽  
Anthony J. Blowers ◽  
Alan C. Gibson
Keyword(s):  
Tardive Dyskinesia ◽  
Psychiatric Patients ◽  
Statistical Significance ◽  
Dosage Level ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Active Medication ◽  
Younger Patient ◽  
Chronic Psychiatric Patients

SynopsisIn a double-blind, placebo-controlled study with co-dergocrine in the treatment of tardive dyskinesia in a group of elderly chronic psychiatric patients the reduction of dyskinetic scores in the group receiving active medication was slightly greater than that in the placebo group; however, this difference did not reach a level of statistical significance. It is suggested that further work could be undertaken with a longer period of treatment, and at a higher dosage level of co-dergocrine, in a younger patient sample.

scholarly journals Effect of n-3 fatty acids on patients with advanced lung cancer: a double-blind, placebo-controlled study

2011 ◽  
Vol 108 (2) ◽  
pp. 327-333 ◽  
Author(s):  
Concetta Finocchiaro ◽  
Olivia Segre ◽  
Maurizio Fadda ◽  
Taira Monge ◽  
Mara Scigliano ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Placebo Group ◽  
Nutritional Status ◽  
Oxidative Status ◽  
Advanced Lung Cancer ◽  
Controlled Study ◽  
Anthropometric Parameters ◽  
Double Blind ◽  
Reactive Protein ◽  
Anti Inflammatory

PUFA from fish oil appear to have anti-inflammatory and anti-oxidative effects and improve nutritional status in cancer patients. With this as background, the aim of the present study was to investigate the effect of EPA plus DHA on inflammatory condition, and oxidative and nutritional status in patients with lung cancer. In our multicentre, randomised, double-blind trial, thirty-three patients with a diagnosis of advanced inoperable non-small-cell lung cancer and undergoing chemotherapy were divided into two groups, receiving four capsules/d containing 510 mg of EPA and 340 mg of DHA, or 850 mg of placebo, for 66 d. At the start of chemotherapy (T0), after 8 d (T1), 22 d (T2) and 66 d (T3), biochemical (inflammatory and oxidative status parameters) and anthropometric parameters were measured in both groups. A significant increase of body weight in the n-3 group at T3v. T0 was observed. Concerning inflammation, C-reactive protein and IL-6 levels differed significantly between the n-3 and placebo groups at T3, and progressively decreased during chemotherapy in the n-3 group, evidencing n-3 PUFA anti-inflammatory action. Concerning oxidative status, plasma reactive oxygen species levels increased in the placebo group v. the n-3 group at the later treatment times. Hydroxynonenal levels increased in the placebo group during the study, while they stabilised in the n-3 group. Our data confirm that the continual assumption of EPA plus DHA determined an anti-inflammatory and anti-oxidative action which could be considered a preliminary goal in anti-cachectic therapy.

The effects of non-viableLactobacilluson immune function in the elderly: a randomised, double-blind, placebo-controlled study

2015 ◽  
Vol 67 (1) ◽  
pp. 67-73 ◽  
Author(s):  
Michio Maruyama ◽  
Ryoji Abe ◽  
Tomohiro Shimono ◽  
Noriyuki Iwabuchi ◽  
Fumiaki Abe ◽  
...  
Keyword(s):  
Immune Function ◽  
The Elderly ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo
Sign in / Sign up

Export Citation Format

Share Document