scholarly journals Intake safety of Lactobacillus helveticus SBT2171 and its effects on nasal and ocular symptoms associated with mites and house dust: An open-label study and a randomized, double-blind, placebo-controlled, parallel group study

2019 ◽  
Vol 9 (1) ◽  
pp. 52 ◽  
Author(s):  
Maya Yamashita ◽  
Eiji Kobatake ◽  
Shun Obuchi ◽  
Masayuki Iwai ◽  
Kazuyuki Ichikawa ◽  
...  
Keyword(s):  
House Dust ◽  
Daily Intake ◽  
Lactobacillus Helveticus ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Double Blind Placebo ◽  
Ocular Symptoms ◽  
Parallel Group

Background: We previously reported that Lactobacillus helveticus SBT2171 (LH2171) inhibited the proliferation and secretion of lipopolysaccharide-stimulated inflammatory cytokines in primary immune cells. Furthermore, in vivo administration of LH2171 has been demonstrated to suppress the incidence and development of murine rheumatoid arthritis. In this study, we evaluated whether the intake of drinkable yogurt (DY) containing LH2171 alleviated nasal and ocular symptoms of allergy to mites and house dust allergens. The safety of LH2171 was also confirmed in an independent, open-label study in 20 healthy subjects who consumed an excessive amount of LH2171.Methods: In study 1, the effect of daily intake of DY containing LH2171 for 12 weeks on nasal and ocular symptoms was evaluated in healthy men and women who tested positive for house dust or mite-specific IgE in a randomized, double-blind, placebo-controlled, parallel group study. One hundred subjects were divided into two groups: subjects taking placebo DY (P group, n = 50) and subjects taking DY containing approximately 1 × 109 cells of LH2171 (LH2171 group, n = 50) daily for the 12 weeks. After excluding subjects that met exclusion criteria, data obtained from 94 subjects (LH2171 group: n = 48; P group: n = 46) were analyzed to establish LH2171 efficacy. LH2171 safety was assessed in an independent, open-label trial in 20 subjects (study 2) who consumed an excessive amount of DY containing approximately 3 × 109 LH2171 cells.Results: In study 1, the decreases in the total scores of the nasal and ocular discomfort between week 0 and week 8 in LH2171 group were significantly larger than those in P group.　 Additionally, the number of sneezes decreased significantly in LH2171 group compared with P group on weeks 9–12 compared to the number of sneezes at baseline. In study 2, no adverse effects of LH2171 on systolic bold pressure, diastolic blood pressure, pulse rate, body weight, blood and urinalysis parameters were reported.Clinical trial registration: UMIN000027791 (study 1), UMIN000029058 (study 2).Conclusion: Daily intake of LH2171 for 12 weeks may regulate immune function and improve nasal and ocular symptoms in the subjects with mite or house dust allergy.

scholarly journals A179 CANADIAN INVOLVEMENT IN THE EVALUATION OF NOVEL THERAPY FOR DIABETIC GASTROPARESIS: OVERVIEW OF PLEDGE TRIALS

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 45-47
Author(s):  
L W Liu ◽  
M Syrzycka ◽  
P Janiszewski ◽  
L Kemps ◽  
B Degeronimo
Keyword(s):  
Diabetic Gastroparesis ◽  
Extension Study ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Safety And Efficacy ◽  
Double Blind Placebo ◽  
The Third ◽  
Parallel Group

Abstract Background Diabetic gastroparesis(DG) is a serious, chronic complication of type 1 or 2 diabetes mellitus(DM) presenting with a delay in gastric emptying(GE). An estimated 3 million Canadians have been diagnosed with DM; up to 5% of these patients may develop DG. DG can result in poor glycemic control, recurrent nausea and vomiting, often resulting in hospitalization. To date, no effective treatments are available. A phase 2 study showed that relamorelin (RLM), a synthetic ghrelin agonist, was safe and effective in treating DG. Investigators across Canada are participating in a set of phase 3 international trials of RLM in the treatment of DG. Aims To report the Canadian involvement in the international effort to evaluate the safety and efficacy of RLM in the treatment of DG. PLEDGE is a set of 5 trials: two identical 12-week studies, a 46-week extension study, a 52-week exposure study, and an open-label extension study. Collectively, the data from these studies will help to evaluate the safety and efficacy of RLM, a novel treatment for Canadian patients living with DG. Methods Four global, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies compare the efficacy of RLM with placebo in participants with DG using composite endpoints of nausea, abdominal pain, postprandial fullness, bloating. Participants are randomized to RLM 10μg or placebo subcutaneously (SC) twice daily groups. The open-label continuation of treatment will follow participants until RLM becomes commercially available to provide long-term safety information to support the safe use of RLM as a chronic treatment of DG. As seen in Figure 1, participants from the two 12-week studies will rollover into the third study that will continue for 46 weeks. The fourth study will enroll participants that were not randomized in the first two studies because their symptoms were less severe and will also accept new participants. Participants will be randomized 2:1 to RLM 10μg or placebo SC twice daily groups. Participants from the third and fourth studies have the option to enroll in the open-label study. Results Target enrollment is approx. 1800 participants for the 4 global, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies and 1000 participants for the open label study. 700 sites are expected to participate globally; 15 Canadian sites in 6 provinces are participating. Conclusions Canadian centers are actively involved in the PLEDGE trials to help determine the efficacy and safety of RLM, a potential new treatment for DG. This publication increases awareness of the Canadian gastroenterology community, providing an option to refer interested patients to PLEDGE study centers. PLEDGE Studies (NCT03285308, NCT03426345, NCT03420781, NCT03383146, NCT03786380): Placebo-controlled, randomized RLM-MD-01/02/03/04 and open-label study 3071-305-020 to study the safety and efficacy of relamorelin for the treatment of diabetic gastroparesis Funding Agencies None

scholarly journals Tasimelteon safely and effectively improves sleep in Smith–Magenis syndrome: a double-blind randomized trial followed by an open-label extension

2021 ◽  
Author(s):  
Christos M. Polymeropoulos ◽  
Justin Brooks ◽  
Emily L. Czeisler ◽  
Michaela A. Fisher ◽  
Mary M. Gibson ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Crossover Study ◽  
Total Sleep Time ◽  
Sleep Time ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Sleep Complaints ◽  
Open Label Extension

Abstract Purpose To assess the efficacy of tasimelteon to improve sleep in Smith–Magenis syndrome (SMS). Methods A 9-week, double-blind, randomized, two-period crossover study was conducted at four US clinical centers. Genetically confirmed patients with SMS, aged 3 to 39, with sleep complaints participated in the study. Patients were assigned to treatment with tasimelteon or placebo in a 4-week crossover study with a 1-week washout between treatments. Eligible patients participated in an open-label study and were followed for >3 months. Results Improvement of sleep quality (DDSQ50) and total sleep time (DDTST50) on the worst 50% of nights were primary endpoints. Secondary measures included actigraphy and behavioral parameters. Over three years, 52 patients were screened, and 25 patients completed the randomized portion of the study. DDSQ50 significantly improved over placebo (0.4, p = 0.0139), and DDTST50 also improved (18.5 minutes, p = 0.0556). Average sleep quality (0.3, p = 0.0155) and actigraphy-based total sleep time (21.1 minutes, p = 0.0134) improved significantly, consistent with the primary outcomes. Patients treated for ≥90 days in the open-label study showed persistent efficacy. Adverse events were similar between placebo and tasimelteon. Conclusion Tasimelteon safely and effectively improved sleep in SMS.

scholarly journals Reduced Self-Perception of Fatigue after Intake of Panax ginseng Root Extract (G115®) Formulated with Vitamins and Minerals—An Open-Label Study

2021 ◽  
Vol 18 (12) ◽  
pp. 6257
Author(s):  
Anne-Laure Tardy ◽  
Beatrice Bois De Fer ◽  
Salvador Cañigueral ◽  
David Kennedy ◽  
Andrew Scholey ◽  
...  
Keyword(s):  
Panax Ginseng ◽  
Daily Intake ◽  
Energy Performance ◽  
Ginseng Root ◽  
Root Extract ◽  
Physical Fatigue ◽  
Self Perception ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

Background: Unexplained fatigue is a common complaint. When underlying disease causes have been eliminated, lifestyle measures and supplementation can be indicated. Elaborating on clinical findings that G115®, a dry extract from the root of Panax ginseng, combined with vitamins and minerals could alleviate fatigue, this open label study aimed at assessing its effect on perceived fatigue and energy. Methods: Healthy adults self-reporting fatigue (n = 103) completed the Multidimensional Fatigue Inventory questionnaire. They rated their perceptions of mental and physical fatigue, energy, performance, and stress at baseline and 15, 30, 60 and 90 days after a daily intake of 40 mg G115® formulated with vitamins and minerals. Results: Compared with baseline values, mean self-perception of general fatigue was reduced by −7.55 units [95% CI: −8.44; −6.66] (−41.8%, p < 0.0001) at 90 days. All assessed perception ratings (mental and physical fatigue, reduced activity and motivation, performance, and stress) were significantly and steadily improved from two weeks after supplementation up to study’s end. Overall satisfaction with the ability of the product to reduce fatigue reached 85% at Day 90. Conclusion: Daily intake with G115® extract formulated with vitamins and minerals suggests an improvement of self-perception of fatigue and energy in a fatigued adult population.

scholarly journals Bifidobacterium bifidum R0071 results in a greater proportion of healthy days and a lower percentage of academically stressed students reporting a day of cold/flu: a randomised, double-blind, placebo-controlled study

2015 ◽  
Vol 113 (3) ◽  
pp. 426-434 ◽  
Author(s):  
Bobbi Langkamp-Henken ◽  
Cassie C. Rowe ◽  
Amanda L. Ford ◽  
Mary C. Christman ◽  
Carmelo Nieves ◽  
...  
Keyword(s):  
Acute Stress ◽  
Bifidobacterium Longum ◽  
Daily Intake ◽  
Bifidobacterium Bifidum ◽  
Lactobacillus Helveticus ◽  
Lower Percentage ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Symptom Intensity

Acute psychological stress is positively associated with a cold/flu. The present randomised, double-blind, placebo-controlled study examined the effect of three potentially probiotic bacteria on the proportion of healthy days over a 6-week period in academically stressed undergraduate students (n 581) who received Lactobacillus helveticus R0052, Bifidobacterium longum ssp. infantis R0033, Bifidobacterium bifidum R0071 or placebo. On each day, participants recorded the intensity (scale: 0 = not experiencing to 3 = very intense) for nine cold/flu symptoms, and a sum of symptom intensity >6 was designated as a day of cold/flu. B. bifidum resulted in a greater proportion of healthy days than placebo (P≤ 0·05). The percentage of participants reporting ≥ 1 d of cold/flu during the 6-week intervention period was significantly lower with B. bifidum than with placebo (P< 0·05). There were no effects of B. infantis or L. helveticus compared with placebo on either outcome. A predictive model accounted for influential characteristics and their interactions on daily reporting of cold/flu episodes. The proportion of participants reporting a cold on any given day was lower at weeks 2 and 3 with B. bifidum and B. infantis than with placebo for the average level of stress and the most commonly reported number of hours of sleep. Daily intake of bifidobacteria provides benefit related to cold/flu outcomes during acute stress.

Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years

2000 ◽  
Vol 6 (4) ◽  
pp. 255-266 ◽  
Author(s):  
K P Johnson ◽  
B R Brooks ◽  
C C Ford ◽  
A Goodman ◽  
J Guarnaccia ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Relapse Rate ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Open Label Phase ◽  
Multiple Sclerosis Patients ◽  
To Receive

In a randomized, placebo-controlled, double-blind study, glatiramer acetate (Copaxone®) reduced the relapse rate and slowed accumulation of disability for patients with relapsing-remitting multiple sclerosis. Of the original 251 patients randomized to receive glatiramer acetate or placebo, 208 chose to continue in an open-label study with all patients receiving active drug. The majority of the original double-blind cohort continues to receive glatiramer acetate by daily subcutaneous injection and are evaluated at 6-month intervals and during suspected relapse. The data reported here are from approximately 6 years of organized evaluation, including the double-blind phase of up to 35 months and the open-label phase of over 36 months. Daily subcutaneous injections of 20 mg glatiramer acetate were well tolerated. The mean annual relapse rate of the patients who received glatiramer acetate since randomization and continued into the open-label study was 0.42 (95% confidence interval (CI), CI=0.34-0.51). The rate per year has continued to drop and for the sixth year is 0.23. Of the group who have received glatiramer acetate without interruption for 5 or more years, 69.3% were neurologically unchanged or have improved from baseline by at least one step on the Expanded Disability Status Scale (EDSS). Patients who left the open-label phase were surveyed by questionnaire. The majority responded, providing information about their current status and reasons for dropping out. This study demonstrates the sustained efficacy of glatiramer acetate in reducing the relapse rate and in slowing the accumulation of disability in patients with relapsing forms of multiple sclerosis.

scholarly journals Effect of 12-Week Daily Intake of the High-Lycopene Tomato (Solanum Lycopersicum), a Variety Named “PR-7”, on Lipid Metabolism: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

Nutrients ◽  
2019 ◽  
Vol 11 (5) ◽  
pp. 1177 ◽  
Author(s):  
Mie Nishimura ◽  
Naoki Tominaga ◽  
Yuko Ishikawa-Takano ◽  
Mari Maeda-Yamamoto ◽  
Jun Nishihira
Keyword(s):  
Placebo Group ◽  
Lipid Metabolism ◽  
Solanum Lycopersicum ◽  
Biological Effects ◽  
Daily Intake ◽  
Vital Signs ◽  
Density Lipoprotein ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Parallel Group

Tomato (Solanum lycopersicum) is a rich source of lycopene, a carotenoid that confers various positive biological effects such as improved lipid metabolism. Here, we conducted a randomized, double-blind, placebo-controlled, parallel-group comparative study to investigate the effects of regular and continuous intake of a new high-lycopene tomato, a variety named PR-7, for 12 weeks, based on 74 healthy Japanese subjects with low-density lipoprotein cholesterol (LDL-C) levels ≥120 to <160 mg/dL. The subjects were randomly assigned to either the high-lycopene tomato or placebo (lycopene-free tomato) group. Each subject in the high-lycopene group ingested 50 g of semidried PR-7 (lycopene, 22.0–27.8 mg/day) each day for 12 weeks, while subjects in the placebo group ingested placebo semidried tomato. Medical interviews were conducted, vital signs were monitored, body composition was determined, and blood and saliva samples were taken at weeks 0 (baseline), 4, 8, and 12. The primary outcome assessed was LDL-C. The intake of high-lycopene tomato increased lycopene levels in this group compared to levels in the placebo group (p < 0.001). In addition, high-lycopene tomato intake improved LDL-C (p = 0.027). The intake of high-lycopene tomato, PR-7, reduced LDL-C and was confirmed to be safe.

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