scholarly journals A Randomized, Placebo-Controlled Trial Assessing the Effect of VISBIOME ES Probiotic in People With HIV on Antiretroviral Therapy

2021 ◽  
Vol 8 (12) ◽  
Author(s):  
Rachel M Presti ◽  
Eunice Yeh ◽  
Brett Williams ◽  
Alan Landay ◽  
Jeffrey M Jacobson ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Inflammatory Marker ◽  
Controlled Trial ◽  
Intestinal Barrier Function ◽  
Fisher Exact Test ◽  
Double Blind Study ◽  
Gut Permeability ◽  
Double Blind ◽  
Markers Of Inflammation ◽  
Cellular Marker

Abstract Background A5350, a phase II, randomized, double-blind study, evaluated the safety and tolerability of the probiotic Visbiome Extra Strength (ES) over 24 weeks and measured effects on inflammation and intestinal barrier function. Methods The primary outcome was change in soluble CD14 (sCD14) levels; secondary outcomes included safety and tolerability, markers of inflammation and cellular activation, and microbiome. In a substudy, gut permeability was assessed by paired colonic biopsies measuring the area of lamina propria occupied by CD4+ cells, interleukin (IL)-17+ cells, and myeloperoxidase (MPO). Changes between arms were compared with the 2-sample t test with equal variance or the Wilcoxon rank-sum test. For safety, the highest graded adverse events (AEs) were compared between arms using the Fisher exact test. Results Overall, 93 participants enrolled: 86% male, median age 51 years, median CD4 count 712 cells/mm3. Visbiome ES was safe and well tolerated. There was no difference in mean change in sCD14 from baseline to week 25/26 between placebo (mean change, 92.3 µg/L; 95% CI, –48.5 to 233 µg/L) and Visbiome ES (mean change, 41.0 µg/L; 95% CI, –94.1 to 176.2 µg/L; P=.60). Similarly, no statistically significant differences between arms in inflammatory marker changes were identified. In substudy participants, no statistical differences between arms for change in cellular marker expression or gut permeability were observed (P>.05 for all). The microbiome demonstrated increased probiotic species and a significant decrease in Gammaproteobacteria (P=.044) in the Visbiome ES arm. Conclusions Visbiome ES was safe and altered the microbiome but demonstrated no effect on systemic inflammatory markers, pathology, or gut permeability in antiretroviral therapy–treated people with HIV.

scholarly journals Long-Term Safety and Efficacy of Prebiotic Enriched Infant Formula—A Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1276
Author(s):  
Franka Neumer ◽  
Orenci Urraca ◽  
Joaquin Alonso ◽  
Jesús Palencia ◽  
Vicente Varea ◽  
...  
Keyword(s):  
Infant Formula ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
First Year ◽  
Double Blind Study ◽  
Double Blind ◽  
Term Infants ◽  
Intention To Treat ◽  
Prebiotic Oligosaccharides ◽  
First Year Of Life

The present study aims to evaluate the effects of an infant formula supplemented with a mixture of prebiotic short and long chain inulin-type oligosaccharides on health outcomes, safety and tolerance, as well as on fecal microbiota composition during the first year of life. In a prospective, multicenter, randomized, double-blind study, n = 160 healthy term infants under 4 months of age were randomized to receive either an infant formula enriched with 0.8 g/dL of Orafti®Synergy1 or an unsupplemented control formula until the age of 12 months. Growth, fever (>38 °C) and infections were regularly followed up by a pediatrician. Digestive symptoms, stool consistency as well as crying and sleeping patterns were recorded during one week each study month. Fecal microbiota and immunological biomarkers were determined from a subgroup of infants after 2, 6 and 12 months of life. The intention to treat (ITT) population consisted of n = 149 infants. Both formulae were well tolerated. Mean duration of infections was significantly lower in the prebiotic fed infants (p < 0.05). The prebiotic group showed higher Bifidobacterium counts at month 6 (p = 0.006), and higher proportions of Bifidobacterium in relation to total bacteria at month 2 and 6 (p = 0.042 and p = 0.013, respectively). Stools of infants receiving the prebiotic formula were softer (p < 0.05). Orafti®Synergy1 tended to beneficially impact total daily amount of crying (p = 0.0594). Supplementation with inulin-type prebiotic oligosaccharides during the first year of life beneficially modulates the infant gut microbiota towards higher Bifidobacterium levels at the first 6 months of life, and is associated with reduced duration of infections.

scholarly journals Single High-Dose Vitamin D Supplementation as an Approach for Reducing Ultramarathon-Induced Inflammation: A Double-Blind Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1280
Author(s):  
Jan Mieszkowski ◽  
Andżelika Borkowska ◽  
Błażej Stankiewicz ◽  
Andrzej Kochanowicz ◽  
Bartłomiej Niespodziński ◽  
...  
Keyword(s):  
Vitamin D ◽  
Inflammatory Marker ◽  
Controlled Trial ◽  
Vitamin D Supplementation ◽  
Oncostatin M ◽  
Control Group ◽  
High Dose ◽  
Double Blind ◽  
Single High Dose ◽  
High Dose Vitamin

Purpose: A growing number of studies indicate the importance of vitamin D supplementation for sports performance. However, the effects of a single high-dose vitamin D supplementation on ultramarathon-induced inflammation have not been investigated. We here analyzed the effect of a single high-dose vitamin D supplementation on the inflammatory marker levels in ultramarathon runners after an ultramarathon run (maximal run 240 km). Methods: In the study, 35 runners (amateurs) were assigned into two groups: single high-dose vitamin D supplementation group, administered vitamin D (150,000 IU) in vegetable oil 24 h before the start of the run (n = 16); and placebo group (n = 19). Blood was collected for analysis 24 h before, immediately after, and 24 h after the run. Results: Serum 25(OH)D levels were significantly increased after the ultramarathon in both groups. The increase was greater in the vitamin D group than in the control group. Based on post-hoc and other analyses, the increase in interleukin 6 and 10, and resistin levels immediately after the run was significantly higher in runners in the control group than that in those in the supplementation group. Leptin, oncostatin M, and metalloproteinase tissue inhibitor levels were significantly decreased in both groups after the run, regardless of the supplementation. Conclusions: Ultramarathon significantly increases the serum 25(OH)D levels. Attenuation of changes in interleukin levels upon vitamin D supplementation confirmed that vitamin D has anti-inflammatory effect on exercise-induced inflammation.

Intravenous dexketoprofen vs placebo for migraine attack in the emergency department: A randomized, placebo-controlled trial

Cephalalgia ◽  
2015 ◽  
Vol 36 (2) ◽  
pp. 179-184 ◽  
Author(s):  
Faruk Gungor ◽  
Kamil Can Akyol ◽  
Mustafa Kesapli ◽  
Ahmet Celik ◽  
Adeviye Karaca ◽  
...  
Keyword(s):  
Emergency Department ◽  
Controlled Trial ◽  
Tertiary Care ◽  
Study Drug ◽  
Final Analysis ◽  
Allocation Concealment ◽  
Double Blind Study ◽  
Care Hospital ◽  
Double Blind ◽  
Migraine Headaches

Objective Migraine is a leading headache etiology that frequently presents to the emergency department (ED). In the present study, we aimed to determine the efficacy of dexketoprofen in aborting migraine headaches in the ED. Methods This prospective, randomized, double-blind study was conducted in an ED of a tertiary care hospital using allocation concealment. Patients were allocated into two arms to receive the study drug; 50 mg dexketoprofen in 50 ml saline and 50 ml saline as placebo. Change in pain intensity was measured by the visual analog scale at baseline, both at 30 and 45 minutes after the study medication was administered. Rescue medication requirement and pain relapse were also recorded by a telephone follow-up at 48 hours. Results A total of 224 patients (112 in each group) were included into the final analysis. Mean age of the study participants was 37 ± 11 (SD) and 25% ( n = 56) of them were male. The median pain improvement at 45 minutes for patients receiving dexketoprofen was 55 (IQR: 49 to 60) and 30 (IQR: 25 to 35) for those receiving placebo. The mean difference between the two groups at 45 minutes was 21.4 (95% CI: 14.4. to 28.5). Rescue drugs were needed in 22.3% of patients who received dexketoprofen compared to 55.4% in patients who received placebo (dif: 33.1%; 95% CI: 20% to 45%). There were no adverse events reported in either group during the study period. Conclusion Intravenous dexketoprofen is superior to placebo in relieving migraine headaches in the ED. It may be a suitable therapy with minimum side effects in patients presenting with a migraine headache to the ED.

scholarly journals DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL OF KAEMPFERIA GALANGA L EXTRACT AS AN ANTI-INFLAMMATION (PROSTAGLANDIN E2 AND TUMOR NECROSIS FACTOR ALPHA) ON OSTEOARTHRITIS

2019 ◽  
pp. 63-66
Author(s):  
NURPUDJI A TASLIM ◽  
M NATSIR DJIDE ◽  
YUSNITA RIFAI ◽  
AKMAL NOVRIAN SYAHRUDDIN ◽  
YOSEFA RIA RAMPO ◽  
...  
Keyword(s):  
Tumor Necrosis Factor ◽  
Prostaglandin E2 ◽  
Tumor Necrosis ◽  
Inflammatory Marker ◽  
Assay Method ◽  
Tnf Alpha ◽  
Enzyme Linked Immunosorbent Assay ◽  
Double Blind ◽  
Markers Of Inflammation ◽  
Necrosis Factor

Objective: The purpose of this study was to compare the effectiveness of the rhizome extract against inflammatory markers such as tumor necrosis factor (TNF)-alpha and prostaglandin E2 (PGE2) with meloxicam in patients with osteoarthritis at knee. Materials and Methods: This study designed two phases as follows: The preparation of rhizome extract in a capsule dosage form which was then followed by double-blind clinical trials, randomized controlled, pre- and post-test design (18 cases) using the WOMAC scores for pain, to markers of inflammation using an enzyme-linked immunosorbent assay method. Results: The results did not reveal any significant differences in pain scores, stiffnesses, and physical function impairment between the intervention (the rhizome extract) and control groups (meloxicam), it either did not reveal any significant differences in the parameters of inflammatory marker TNF alpha and PGE2 among the groups. Conclusion: The rhizome extract had the same effect on pain, stiffness, physical interference as meloxicam, and on PGE2 as well as on the inflammatory marker TNF-alpha. Therefore, this extract can be used as an alternative herbal medicine for osteoarthritis.

scholarly journals Hydroxychloroquine for prevention of recurrent miscarriage: study protocol for a multicentre randomised placebo-controlled trial BBQ study

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e025649 ◽  
Author(s):  
Elisabeth Pasquier ◽  
Luc de Saint-Martin ◽  
Gisèle Marhic ◽  
Celine Chauleur ◽  
Caroline Bohec ◽  
...  
Keyword(s):  
Recurrent Miscarriage ◽  
Low Cost ◽  
Controlled Trial ◽  
Oral Treatment ◽  
Safety Data ◽  
Live Birth Rate ◽  
First Trimester ◽  
Double Blind Study ◽  
Double Blind ◽  
Underlying Mechanisms

IntroductionRecurrent miscarriage (RM), defined by three or more consecutive losses during the first trimester of pregnancy, affects 1%–2% of fertile couples. Standard investigations fail to reveal any apparent cause in ~50% of couples. However, on the basis of animal models and clinical studies, several hypotheses have been put forward concerning underlying mechanisms of RM: altered ovarian reserve, progesterone defect, thrombotic and/or endothelial dysfunction and immunological disturbances. Nonetheless, no study has yet reached conclusive beneficial clinical evidence for a potential treatment in unexplained RM. Hydroxychloroquine (HCQ) is a molecule with extensive safety data during pregnancy. The pharmacological properties of HCQ (eg, antithrombotic, vascular protective, immunomodulatory, improved glucose tolerance, lipidlowering and anti-infectious) could be effective against some mechanisms of unexplained RM. Furthermore, eventhough clinical benefit of HCQ is suggested in prevention of thrombotic and late obstetric events in antiphospholipid (APL) syndrome, there are no data suggesting the benefit of HCQ in RM in the presence of APL antibodies.Methods and analysisTaken all together and given the low cost of HCQ, the aim of this multicentre, randomised, placebo-controlled, double-blind study is to investigate whether HCQ would improve the live birth rate in women with RM, irrespective of maternal thrombophilic status: (1) no known thrombophilia, (2) inherited thrombophilia or (3) APL antibodies. The primary end point is a live and viable birth. After confirming eligibility and obtaining consent, 300 non-pregnant women will be randomised into two parallel groups for a daily oral treatment (HCQ 400 mg or placebo), initiated before conception and stopped at 10 weeks’ gestation. If pregnancy does not occur after 1 year, the treatment will be stopped.Ethics and disseminationAgreement from the French National Public Health and Drug Security Agency (160765A-22) and ethical approval from the Committee for the Protection of Persons of NORD-OUEST I (2016-001330-97) have been obtained.Trial registration numbersNCT0316513; Pre-results.

Combined nitrous oxide 70% with intranasal fentanyl for procedural analgosedation in children: a prospective, randomised, double-blind, placebo-controlled trial

2019 ◽  
Vol 36 (3) ◽  
pp. 142-147 ◽  
Author(s):  
Michelle Seiler ◽  
Georg Staubli ◽  
Markus A. Landolt
Keyword(s):  
Nitrous Oxide ◽  
Adverse Events ◽  
Scale Score ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Pain Scale ◽  
Double Blind Study ◽  
Double Blind ◽  
Significant Group ◽  
Registration Number

ObjectiveNitrous oxide 70% (N2O 70%) is an excellent medication for procedural analgosedation (PAS), yet the limit of its analgesic power remains uncertain; therefore, a combination with intranasal fentanyl (INF) was suggested. However, this combination seems to result in a higher rate of vomiting and deeper sedation. This study aimed at assessing the analgesic efficacy, sedation depth and rate of adverse events of PAS with N2O 70% with and without INF.MethodsPatients aged 2–16 years who qualified for PAS with N2O 70% were randomly assigned to receive either INF or placebo prior to N2O inhalation in this randomised, double-blind study, which was performed in a tertiary children’s hospital ED between September 2015 and October 2017. Behaviour during the procedure was evaluated using the Face, Leg, Activity, Cry and Consolability (FLACC) scale and the Modified Behavioural Pain Scale (MBPS); analgesic efficacy was assessed with a self-reported pain scale. Sedation depth using the validated University of Michigan Sedation Scale and adverse events in the ED and during the following 12 hours were documented.ResultsA total of 402 patients were included; 3 did not tolerate N2O and therefore had to be excluded. Overall, 399 patients were analysed, of whom 201 (50.4%) received INF. No significant group differences with regard to FLACC scale score, self-reported pain, MBPS score and sedation depth were found. In addition, the two groups did not differ with regard to all types of adverse events.ConclusionCombining N2O 70% with INF resulted in no differences with regard to FLACC scale score, self-reported pain, MBPS score, patient and parental satisfaction rate, sedation depth, and adverse events.Trial registration numberNCT02533908

Randomized phase III trial of regorafenib in patients (pts) with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) progressing despite prior treatment with at least imatinib (IM) and sunitinib (SU): GRID trial.

2012 ◽  
Vol 30 (18_suppl) ◽  
pp. LBA10008-LBA10008 ◽  
Author(s):  
George D. Demetri ◽  
Peter Reichardt ◽  
Yoon-Koo Kang ◽  
Jean-Yves Blay ◽  
Heikki Joensuu ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Controlled Trial ◽  
Performance Status ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Double Blind Study ◽  
Open Label ◽  
Ecog Performance Status ◽  
Double Blind ◽  
Multikinase Inhibitor

LBA10008 Background: Oral multikinase inhibitor regorafenib (REG) demonstrated substantial activity in a phase II trial in pts with GIST after failure of both IM and SU (J Clin Oncol. 2011; 29:606s; abstr 10007). This phase III, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of REG for this unmet clinical need. Methods: Eligible pts had metastatic and/or unresectable GIST, objective failure of both prior IM and SU (progressive disease [PD] on, or intolerance to, IM and PD on SU), ≥1 measurable lesion, ECOG performance status 0 or 1. Pts were randomized 2:1 to receive best supportive care plus either REG 160 mg po once daily (3 wks on/1 wk off) or placebo (PL). The primary endpoint was progression-free survival (PFS) (modified RECIST 1.1, independent central review). Secondary endpoints included overall survival (OS), disease control rate (DCR, defined as rate of partial response [PR] plus stable disease [SD] lasting for ≥12 wks), response rate and duration, safety and correlative genotype analyses. At time of PD, pts were eligible for unblinding and crossover to open-label REG. Results: Between Jan and Aug of 2011, 234 pts were screened; 199 were randomized (REG: 133, PL: 66). Pts were stratified at randomization according to number of prior systemic therapies and geographical region. Baseline characteristics were balanced between the two arms. The primary endpoint was met: median PFS was 4.8 months for REG vs. 0.9 months for PL. Hazard ratio for PFS was 0.27 (95% CI, 0.18-0.39), p<0.0001. PFS rates at 3 and 6 months were 60% and 38% for REG vs. 11% and 0% for PL. DCR was 53% (REG) vs. 9% (PL).The HR for OS was 0.77 (p=0.20) with 85% PL pts having crossed over to REG. The most common > grade 3 treatment-emergent AEs in the REG arm during double-blind study were hypertension (28%), hand-foot skin reaction (21%), and diarrhea (8%). Conclusions: This randomized trial demonstrated that REG significantly improved PFS and DCR in pts with advanced GIST after failure of at least prior IM and SU. REG was well tolerated, with AEs as expected for this class and manageable with dose modifications.

Randomized Controlled Trial Evaluating Pictogram Augmentation of HIV Medication Information

2011 ◽  
Vol 45 (11) ◽  
pp. 1378-1383 ◽  
Author(s):  
Kyle Wilby ◽  
Carlo A Marra ◽  
Jack H da Silva ◽  
Maja Grubisic ◽  
Stephanie Harvard ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Antiretroviral Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Fisher Exact Test ◽  
Intended Meaning ◽  
Randomized Controlled ◽  
Medication Information

Background:: Antiretroviral therapy for the management of HIV typically requires the chronic use of 3 or more medications. As such, patients with HIV are required to manage complex dosing schedules and are at risk of multiple potential adverse effects. The use of pictograms on medication vials as a means of improving patients' understanding of medication information has been shown to positively influence understanding and adherence compared to those using text atone. Objective: To determine whether pictograms (Pharmaglyph) increase patient recall of targeted information associated with HIV medications and whether patients can interpret the intended meaning of pictograms that they had not seen previously. Methods: A randomized, controlled trial was conducted in HIV-positive patients aged 19 years or older who were receiving a new prescription for an antiretroviral medication from the ambulatory pharmacy at St. Paul's Hospital in Vancouver, British Columbia, Canada. Participants were randomized to receive either pictogram-enhanced medication information or standard counseling. At the first follow-up visit, each patient's recall of the medication information was evaluated, and differences between groups were compared. Results: Eighty-two subjects were randomized, 40 to the intervention group and 42 to the control arm. The mean (SD) number of HIV medications was nearly equal between the intervention and control groups: 3.0 (1.5) and 3.1 (1.4), respectively. After a mean of 34 days, 33 patients in the intervention arm and 39 in the control arm completed the study. The majority (88%) of the targeted pieces of information in the intervention group were correctly identified at follow-up, compared to only 2% in the control group (Fisher exact test; p < 0.0001). Conclusions: Pictograms improve the recall of targeted medication information among patients receiving antiretroviral therapy for HIV management; however, this appears to be dependent on the fact that these patients received a verbal explanation of each pictogram prior to use.

scholarly journals Comparison of Intrathecal Fentanyl and Butorphanol as an Adjuvant to Intrathecal Bupivacaine 0.5% in Infraumbilical Surgeries- A Randomised Double Blind Study

2020 ◽  
Author(s):  
Sandip Roy Basunia ◽  
Prosenjit Mukherjee ◽  
Md Bakir Hossain Munshi
Keyword(s):  
Spinal Anaesthesia ◽  
Motor Block ◽  
Controlled Trial ◽  
Sensory Block ◽  
P Value ◽  
Double Blind Study ◽  
Hyperbaric Bupivacaine ◽  
Double Blind ◽  
Group A ◽  
Group B

Introduction: Neuraxial opioids are widely used as adjuvants to local anaesthetic as they improve quality and duration of block. Neuraxial opioids like Butorphanol and Fentanyl allow prolonged analgesia in the postoperative period and faster recovery from spinal anaesthesia. Aim: To compare the safety and efficacy of Butorphanol and Fentanyl combined with bupivacaine for spinal anaesthesia in infraumbilical surgeries. Materials and Methods: The present study was a randomised controlled trial in which 110, ASA I and II patients of either sex who underwent elective infraumbilical surgeries under spinal anaesthesia were selected. Patients were allocated randomly into two groups A (n=55) and B (n=55). Group A (F) received intrathecal 0.5% hyperbaric bupivacaine 12.5 mg (3 mL) with fentanyl 25 microgram (0.5 mL) to make it total 3.5 mL. Group B (B) received intrathecal 0.5% hyperbaric bupivacaine 12.5 mg (3 mL) with butorphanol 250 microgram (0.25 mL) and Normal Saline (NS) 0.25 mL to make it total 3.5 mL. Heart Rate (HR), Systolic and Diastolic Blood Pressure (SBP, DBP), two segment regression time of sensory block, motor block were assessed at preset intervals. Chi-square test or Fischer’s-exact test were used and a p-value ≤0.05 was considered as statistically significant. Results: Mean of two segment sensory regression time of Group A was 41.94±1.73 minutes and Group B was 50.56±4.43 minutes (p<0.0001). Time to onset of motor block in Group A was 5.28±.32 minutes and Group B was 5.27±.32 minutes (p=0.96). Mean duration of motor block in Group A was 81.23±4.87 minutes and Group B was 109.83±2.61 minutes (p<0.0001). Time to rescue analgesic was 289.27±7.37 minutes in Group A and 378.41±10.25 minutes in Group B (p<0.0001). HR, SBP and DBP were comparable among the groups. Conclusion: Intrathecal bupivacaine-butorphanol mixture was clinically better as it provided longer duration of analgesia with lesser incidences of pruritus and nausea/vomiting compared to intrathecal fentanyl-bupivacaine mixture.

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