scholarly journals Effects ofLactobacillus gasseriOLL2716 onHelicobacter pylori-Associated Dyspepsia: A Multicenter Randomized Double-Blind Controlled Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Atsushi Takagi ◽  
Hidetaka Yanagi ◽  
Hideki Ozawa ◽  
Naomi Uemura ◽  
Shigemi Nakajima ◽  
...  
Keyword(s):  
Epigastric Pain ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
University Hospital ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Postprandial Fullness ◽  
Medical Network ◽  
H Pylori ◽  
The University

SomeLactobacillusspp. suppressHelicobacter pyloriin the stomach and have potential therapeutic applications for the treatment of gastrointestinal conditions. In this study, the effects ofLactobacillusstrains on functional dyspepsia associated withH. pyloriinfection were examined. Volunteers were screened using the13C-urea breath test (UBT) andH. pyloristool test, and 131 participants who met the selection criteria (mean age: 48.9 years) were randomly givenL. gasseriOLL2716-containing yogurt or placebo yogurt once daily for 12 weeks. Gastrointestinal symptoms (epigastric pain, bloating, postprandial fullness, nausea, and heartburn) and the levels of serum pepsinogen (PG),13C-UBT, andH. pyloristool antigen were assessed. No significant differences were observed between the groups in UBT results,H. pyloristool antigens, or the serum PGI/II ratio. In theL. gasserigroup, postprandial fullness was significantly lower at the end of the trial compared to the initial level (p<0.05) and significantly fewer patients had a VAS score of >10 for bloating compared to the placebo group (p<0.05). Dietary supplementation withL. gasseriOLL2716-containing yogurt may effectively suppress dyspeptic symptoms inH. pylori-infected patients. This study was registered at the University Hospital Medical Network Clinical Trial Registry (UMIN000016746).

scholarly journals Acute Effects of Triiodothyronine on Endothelial Function in Human Subjects

2007 ◽  
Vol 92 (1) ◽  
pp. 250-254 ◽  
Author(s):  
Raffaele Napoli ◽  
Vincenzo Guardasole ◽  
Valentina Angelini ◽  
Emanuela Zarra ◽  
Daniela Terracciano ◽  
...  
Keyword(s):  
Endothelial Function ◽  
Dose Response ◽  
Vascular Reactivity ◽  
Controlled Trial ◽  
University Hospital ◽  
Acute Effects ◽  
Response Curves ◽  
Double Blind ◽  
Low T3 ◽  
Dose Response Curves

Abstract Context: Thyroid hormone regulates several cardiovascular functions, and low T3 levels are frequently associated with cardiovascular diseases. Whether T3 exerts any acute and direct effect on endothelial function in humans is unknown. Objective: Our objective was to clarify whether acute changes in serum T3 concentration affect endothelial function. Design, Setting, and Subjects: Ten healthy subjects (age, 24 ± 1 yr) participated in a double-blind, placebo-controlled trial at a university hospital. Interventions: T3 (or placebo) was infused for 7 h into the brachial artery to raise local T3 to levels observed in moderate hyperthyroidism. Vascular reactivity was tested by intraarterial infusion of vasoactive agents. Main Outcome Measures: We assessed changes in forearm blood flow (FBF) measured by plethysmography. Results: FBF response to the endothelium-dependent vasodilator acetylcholine was enhanced by T3 (P = 0.002 for the interaction between T3 and acetylcholine). The slopes of the dose-response curves were 0.41 ± 0.06 and 0.23 ± 0.04 ml/dl·min/μg in the T3 and placebo study, respectively (P = 0.03). T3 infusion had no effect on the FBF response to sodium nitroprusside. T3 potentiated the vasoconstrictor response to norepinephrine (P = 0.006 for the interaction). Also, the slopes of the dose-response curves were affected by T3 (1.95 ± 0.77 and 3.83 ± 0.35 ml/dl·min/mg in the placebo and T3 study, respectively; P &lt; 0.05). The increase in basal FBF induced by T3 was inhibited by NG-monomethyl-l-arginine. Conclusions: T3 exerts direct and acute effects on the resistance vessels by enhancing endothelial function and norepinephrine-induced vasoconstriction. The data may help clarify the vascular impact of the low T3 syndrome and point to potential therapeutic strategies.

scholarly journals Efficacy of Oral Acetaminophen and Intravenous Chlorpheniramine Maleate versus Placebo to Prevent Red Cell Transfusion Reactions in Children and Adolescent with Thalassemia: A Prospective, Randomized, Double-Blind Controlled Trial

Anemia ◽  
2018 ◽  
Vol 2018 ◽  
pp. 1-8 ◽  
Author(s):  
Piya Rujkijyanont ◽  
Chalinee Monsereenusorn ◽  
Pimpat Manoonphol ◽  
Chanchai Traivaree
Keyword(s):  
Blood Transfusion ◽  
Controlled Trial ◽  
Febrile Reaction ◽  
Chlorpheniramine Maleate ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Urticarial Rash ◽  
To Receive ◽  
Transfusion Reactions ◽  
Rbc Transfusion

Background. Thalassemia is a common congenital hemolytic disorder. In severe cases, regular blood transfusion is essentially required. The role of premedications to prevent transfusion reactions is varied among institutions with no standard guideline. Objective. To prospectively compare the risk of transfusion reactions in thalassemia patients premedicated with acetaminophen and chlorpheniramine maleate (CPM) versus placebo prior to blood transfusion. Material and Method. A randomized, double-blinded, placebo-controlled transfusion reaction study of 147 eligible patients was analyzed. All administered red blood cell (RBC) products were leukoreduced blood products. Patients were monitored and followed for the development of transfusion reactions for 24 hours after RBC transfusion. Results. A total of 73 patients randomized to receive active drugs consisting of acetaminophen and CPM were compared to 74 patients receiving placebo. The overall incidences of febrile reaction and urticarial rash were 6.9% and 22% in the patients randomized to receive active drugs comparing with 9.5% and 35.2% in the patients receiving placebo with no significant differences between two groups. However, delayed development of urticarial rash at 4-24 hours after RBC transfusion was significantly higher in female and patients receiving placebo. Conclusion. Administration of premedications in thalassemia patients receiving RBC transfusion without a history of transfusion reactions does not decrease the overall risk of transfusion reactions. However, the use of CPM might be beneficial to prevent delayed urticarial rash in those patients especially in females (Thai Clinical Trial Registry (TCTR) study ID: 20140526001).

scholarly journals Standard Triple Therapy versus Sequential Therapy inHelicobacter pyloriEradication: A Double-Blind, Randomized, and Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-5 ◽  
Author(s):  
Jaime Natan Eisig ◽  
Tomás Navarro-Rodriguez ◽  
Ana Cristina Sá Teixeira ◽  
Fernando Marcuz Silva ◽  
Rejane Mattar ◽  
...  
Keyword(s):  
Triple Therapy ◽  
Controlled Trial ◽  
Sequential Therapy ◽  
Rapid Urease Test ◽  
Double Blind ◽  
Intention To Treat ◽  
Standard Triple Therapy ◽  
Urease Test ◽  
H Pylori ◽  
Triple Treatment

Aim. To compare 10-day standard triple therapy versus sequential therapy as first-line treatment in patients infected withH. pylori.Methods. One hundredH. pyloripositive patients (diagnosed by rapid urease test and histology), with average age of 47.2, M/F = 28/72, were randomized to receive either standard triple treatment (TT) as follows: lansoprazole 30 mg, clarithromycin 500 mg, and amoxicillin 1 g, b.i.d. for ten days, or sequential treatment (ST) as follows: lansoprazole 30 mg, amoxicillin and placebo 1.0 g b.i.d for the first five days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and tinidazole 500 mg b.i.d, for the remaining five days. Eradication rates were determined 60 days after treatment by urease, histology, or13C-urea breath test.Results. In intention to treat (ITT) analysis, the rate ofH. pylorieradication in the TT and ST groups was the same for both regimens as follows: 86% (43/50), 95% CI 93,3 to 73.4%. In Per protocol (PP) analysis, the rate ofH. pylorieradication in the TT and ST groups was 87.8% (43/49), 95% CI 94,5 to 75.3% and 89.6% (43/48), 95% CI 95,8 to 77.3%, respectively.Conclusions. In Brazil, standard triple therapy is as equally effective as sequential therapy in eradicatingHelicobacter pyloripatients. This study was registered under Clinical Trials with numberISRCTN62400496.

scholarly journals A machine learning approach for identification of gastrointestinal predictors for the risk of COVID-19 related hospitalization

2021 ◽  
Author(s):  
Peter Liptak ◽  
Peter Banovcin ◽  
Robert Rosolanka ◽  
Michal Prokopic ◽  
Ivan Kocan ◽  
...  
Keyword(s):  
Machine Learning ◽  
Emergency Department ◽  
Random Forest ◽  
Gastrointestinal Symptoms ◽  
Machine Learning Algorithms ◽  
Important Predictor ◽  
University Hospital ◽  
Home Based ◽  
Severity Of The Disease ◽  
The University

Background and aim: COVID-19 can be presented with various gastrointestinal symptoms. Shortly after the pandemic outbreak several machine learning algorithms have been implemented to assess new diagnostic and therapeutic methods for this disease. Aim of this study is to assess gas-trointestinal and liver related predictive factors for SARS-CoV-2 associated risk of hospitalization. Methods: Data collection was based on questionnaire from the COVID-19 outpatient test center and from the emergency department at the University hospital in combination with data from inter-nal hospital information system and from the mobile application used for telemedicine follow-up of patients. For statistical analysis SARS-CoV-2 negative patients were considered as controls to three different SARS-CoV-2 positive patient groups (divided based on severity of the disease). Results: Total of 710 patients were enrolled in the study. Presence of diarrhea and nausea was significantly higher in emergency department group than in the COVID-19 outpatient test center. Among liver enzymes only aspartate transaminase (AST) has been significantly elevated in the hospitalized group compared to patients discharged home. Based on random forest algorithm, AST has been identified as the most important predictor followed by age or diabetes mellitus. Diarrhea and bloating have also predictive importance although much lower than AST. Conclusion: SARS-CoV-2 positivity is connected with isolated AST elevation and the level is linked with the severity of the disease. Furthermore, using machine learning random forest algo-rithm, we have identified elevated AST as the most important predictor for COVID-19 related hos-pitalizations.

scholarly journals Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: A multicenter, randomized, double-blind, placebo-controlled trial

2020 ◽  
Author(s):  
Jun Ni ◽  
Huisheng Chen ◽  
Guofang Chen ◽  
Yong Ji ◽  
Fei Yi ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Thrombolytic Therapy ◽  
Acute Ischemic Stroke ◽  
Barthel Index ◽  
Controlled Trial ◽  
Survival Rates ◽  
Control Group ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Double Blind

Abstract Background: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 hours of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke.Methods: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram.Results: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p=0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p=0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups.Conclusions: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported.Trial registration: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827. Retrospectively registered June 13, 2019.

scholarly journals Helicobacter pylori infection in Iran: demographic, endoscopic and pathological factors

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Seyedeh Amineh Hojati ◽  
Sara Kokabpeyk ◽  
Salma Yaghoubi ◽  
Farahnaz Joukar ◽  
Mehrnaz Asgharnezhad ◽  
...  
Keyword(s):  
Helicobacter Pylori ◽  
Peptic Ulcer ◽  
Epigastric Pain ◽  
Tap Water ◽  
Clinical Manifestations ◽  
Gastrointestinal Symptoms ◽  
Common Symptom ◽  
Pathological Findings ◽  
Significant Difference ◽  
H Pylori

Abstract Background Helicobacter pylori (H. pylori) infection is the most important risk factor for gastritis and peptic ulcer. However, factors other than H. pylori are involved in its pathogenesis. In the current study, we aimed to compare the clinical manifestations and endoscopic and histopathological findings of patients with and without H. pylori infection. Methods In this cross-sectional study, 233 patients with dyspepsia, referred for endoscopy, were examined regarding the presence of H. pylori infection. During an endoscopic exam, 5 biopsy specimens were taken from the stomach. The criteria for the presence of H. pylori infection was the presence and identification of bacteria in pathology. Two groups of H. pylori-positive and H. pylori-negative patients were compared regarding their demographic, endoscopic, and pathological findings. Results Of 233 patients, 154 (66.1%) were non-smokers, 201 (86.3%) were not alcohol users, and 153 (65.7%) used tap water. The most common symptom, reported in 157 (67.4%) patients, was epigastric pain. There was a significant difference between patients with and without H. pylori infection in terms of the educational status, occupational status, family history of gastrointestinal cancer, and some gastrointestinal symptoms. Also, there was a significant relationship between the endoscopic and pathological findings of patients with H. pylori. Conclusions The results of the present study revealed that H. pylori infection was not associated with sex, alcohol consumption, or non-steroidal anti-inflammatory drug use. The role of H. pylori in the pathophysiology of peptic ulcer was clarified. Also, there was a significant difference in the endoscopic and pathological findings of patients with H. pylori.

scholarly journals Effects of daily L-dopa administration on learning and brain structure in older adults undergoing cognitive training: a randomised clinical trial

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Alexander V. Lebedev ◽  
Jonna Nilsson ◽  
Joanna Lindström ◽  
William Fredborg ◽  
Ulrika Akenine ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cognitive Training ◽  
Cognitive Aging ◽  
Latent Variables ◽  
Fluid Intelligence ◽  
Controlled Trial ◽  
Basic Research ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Healthy Elderly

AbstractCognitive aging creates major individual and societal burden, motivating search for treatment and preventive care strategies. Behavioural interventions can improve cognitive performance in older age, but effects are small. Basic research has implicated dopaminergic signalling in plasticity. We investigated whether supplementation with the dopamine-precursor L-dopa improves effects of cognitive training on performance. Sixty-three participants for this randomised, parallel-group, double-blind, placebo-controlled trial were recruited via newspaper advertisements. Inclusion criteria were: age of 65–75 years, Mini-Mental State Examination score >25, absence of serious medical conditions. Eligible subjects were randomly allocated to either receive 100/25 mg L-dopa/benserazide (n = 32) or placebo (n = 31) prior to each of twenty cognitive training sessions administered during a four-week period. Participants and staff were blinded to group assignment. Primary outcomes were latent variables of spatial and verbal fluid intelligence. Compared to the placebo group, subjects receiving L-dopa improved less in spatial intelligence (−0.267 SDs; 95%CI [−0.498, −0.036]; p = 0.024). Change in verbal intelligence did not significantly differ between the groups (−0.081 SDs, 95%CI [−0.242, 0.080]; p = 0.323). Subjects receiving L-dopa also progressed slower through the training and the groups displayed differential volumetric changes in the midbrain. No statistically significant differences were found for the secondary cognitive outcomes. Adverse events occurred for 10 (31%) and 7 (23%) participants in the active and control groups, correspondingly. The results speak against early pharmacological interventions in older healthy adults to improve broader cognitive functions by targeting the dopaminergic system and provide no support for learning-enhancing properties of L-dopa supplements in the healthy elderly. The findings warrant closer investigation about the cognitive effects of early dopamine-replacement therapy in neurological disorders. This trial was preregistered at the European Clinical Trial Registry, EudraCT#2016-000891-54 (2016-10-05).

scholarly journals Effectiveness of an antenatal maternal supplementation with prebiotics for preventing atopic dermatitis in high-risk children (the PREGRALL study): protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (4) ◽  
pp. e024974 ◽  
Author(s):  
Clémentine Cabridain ◽  
Hélène Aubert ◽  
Bertrand Kaeffer ◽  
Virginie Badon ◽  
Marion Boivin ◽  
...  
Keyword(s):  
At Risk ◽  
Atopic Dermatitis ◽  
High Risk ◽  
Controlled Trial ◽  
Working Party ◽  
University Hospital ◽  
Ethical Review ◽  
Double Blind ◽  
Maternal Supplementation ◽  
High Risk Children

IntroductionAtopic dermatitis (AD) is a chronic inflammatory disease affecting 10%–15% of children in Europe. There is a need for new primary preventive therapeutic strategies in at-risk populations. Recent research has indicated that atopic diseases are associated with a disrupted gut microbial ‘balance’ in early life raising the possibility that interventions which yield optimal patterns of microflora could improve host’s health. Prebiotics, sugars with immunomodulatory properties that stimulate the diversity of the digestive microbiota, are ideal candidates for such research. So far, most clinical trials have focused on improving infant gut colonisation postnatally. However, prenatal life is a crucial period during which different tolerance mechanisms are put in place. We aim to determine whether antenatal prebiotics supplementation prevents AD in high-risk children.Methods and analysisThis is a randomised, multicentre, double-blind, trial to evaluate the effectiveness of antenatal prebiotic maternal supplementation (galacto-oligosaccharide/inulin) in pregnant women versus placebo on the occurrence of AD at 1 year of age in at-risk children (defined as having a maternal history of atopic disease). Participating women will be randomised to daily ingestion of a prebiotics or placebo (maltodextrin) from 20 weeks’ gestation until delivery. The primary outcome is the prevalence of AD at 1 year of age, using the version of the UK Working Party Diagnostic Criteria optimised for preventive studies. Key secondary endpoints are AD severity, quality of life and prebiotics tolerance. The target sample size is 376 women (188 patients per group) which will provide 80% power to detect a 33% reduction of the risk of AD in the verum group (α=0.05). The primary analysis will be based on the intention-to-treat principle.Ethics and disseminationResults will be presented in peer-reviewed journals and at international conferences. Ethics approval for the study was obtained from the institutional ethical review board of ‘Comité de Protection des Personnes Sud Ouest—Outre-Mer III’ of the University Hospital Centre of Bordeaux (2017/13).Trial registration numberNCT03183440; Pre-results.

scholarly journals Weekly iron–folic acid supplements containing 2.8 mg folic acid are associated with a lower risk of neural tube defects than the current practice of 0.4 mg: a randomised controlled trial in Malaysia

2020 ◽  
Vol 5 (12) ◽  
pp. e003897
Author(s):  
Kaitlyn L I Samson ◽  
Su Peng Loh ◽  
Siew Siew Lee ◽  
Dian C Sulistyoningrum ◽  
Geok Lin Khor ◽  
...  
Keyword(s):  
Folic Acid ◽  
Neural Tube ◽  
Controlled Trial ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
Folic Acid Supplements ◽  
Registration Number ◽  
Menstruating Women ◽  
Iron Folic Acid ◽  
Randomised Controlled

IntroductionWeekly iron–folic acid (IFA) supplements are recommended for all menstruating women in countries where anaemia prevalence is >20%. Anaemia caused by folate deficiency is low worldwide, and the need to include folic acid is in question. Including folic acid might reduce the risk of a neural tube defect (NTD) should a woman become pregnant. Most weekly supplements contain 0.4 mg folic acid; however, WHO recommends 2.8 mg because it is seven times the daily dose effective in reducing NTDs. There is a reluctance to switch to supplements containing 2.8 mg of folic acid because of a lack of evidence that this dose would prevent NTDs. Our aim was to investigate the effect of two doses of folic acid, compared with placebo, on red blood cell (RBC) folate, a biomarker of NTD risk.MethodsWe conducted a three-arm double-blind efficacy trial in Malaysia. Non-pregnant women (n=331) were randomised to receive 60 mg iron and either 0, 0.4, or 2.8 mg folic acid once weekly for 16 weeks.ResultsAt 16 weeks, women receiving 0.4 mg and 2.8 mg folic acid per week had a higher mean RBC folate than those receiving 0 mg (mean difference (95% CI) 84 (54 to 113) and 355 (316 to 394) nmol/L, respectively). Women receiving 2.8 mg folic acid had a 271 (234 to 309) nmol/L greater mean RBC folate than those receiving 0.4 mg. Moreover, women in the 2.8 mg group were seven times (RR 7.3, 95% CI 3.9 to 13.7; p<0.0001) more likely to achieve an RBC folate >748 nmol/L, a concentration associated with a low risk of NTD, compared with the 0.4 mg group.ConclusionWeekly IFA supplements containing 2.8 mg folic acid increases RBC folate more than those containing 0.4 mg. Increased availability and access to the 2.8 mg formulation is needed.Trail registration numberThis trial is registered with the Australian New Zealand Clinical Trial Registry (ACTRN12619000818134).

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