Effectiveness of nutritional treatment and synbiotic use on gastrointestinal symptoms reduction in HIV-infected patients: Randomized clinical trial

2017 ◽  
Vol 36 (3) ◽  
pp. 680-685 ◽  
Author(s):  
Annelisa Silva e Alves de Carvalho Santos ◽  
Erika Aparecida da Silveira ◽  
Marianne Oliveira Falco ◽  
Max Weyler Nery ◽  
Marilia Dalva Turchi
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Gastrointestinal Symptoms ◽  
Nutritional Treatment

scholarly journals Pre-exposure prophylaxis with hydroxychloroquine for COVID-19: initial results of a double-blind, placebo-controlled randomized clinical trial

2020 ◽  
Author(s):  
Berta Grau-Pujol ◽  
Daniel Camprubí ◽  
Helena Marti-Soler ◽  
Marc Fernández-Pardos ◽  
Clara Carreras-Abad ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Healthcare Workers ◽  
Gastrointestinal Symptoms ◽  
Similar Proportion ◽  
Control Group ◽  
Treatment Schedule ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Exposure Prophylaxis

Abstract BackgroundPre-exposure prophylaxis (PrEP) is a promising strategy to break COVID-19 transmission. Although hydroxychloroquine was evaluated for treatment and post-exposure prophylaxis, it is not evaluated for COVID-19 PrEP yet. The aim of this study was to evaluate efficacy and safety of PrEP with hydroxychloroquine against placebo in healthcare workers at high risk of SARS-CoV-2 infection during an epidemic period.MethodsWe conducted a double-blind placebo-controlled randomized clinical trial in three hospitals in Barcelona, Spain. From 350 adult healthcare workers screened, we included 269 participants with no active or past SARS-CoV-2 infection (determined by a negative nasopharyngeal SARS-CoV-2 PCR and a negative serology against SARS-CoV-2). Participants allocated in the intervention arm (PrEP) received 400mg of hydroxychloroquine daily the first four consecutive days and subsequently, 400mg weekly during the study period. Participants in the control group followed the same treatment schedule with placebo tablets. Results52.8% of participants were in the hydroxychloroquine arm and 47.2% in the placebo arm. Both groups showed similar proportion of participants experiencing at least one adverse event (AE) (p=0.548). No serious AE were reported. Almost all AE (96.4%) were mild. Only mild gastrointestinal symptoms were significantly higher in the hydroxychloroquine arm compared to the placebo arm (28.3% vs 16.9%, p=0.044). Given the national epidemic incidence decay, only one participant in each group was COVID-19 diagnosed. Consequently, our study design deemed underpowered to evaluate any benefit regarding PrEP efficacy.ConclusionsFirst month follow-up analysis displayed that PrEP with hydroxychloroquine at low doses is safe.Trial registrationThis trial was registered at clinicaltrials.gov (NCT04331834) on April 2nd 2020.

Efficacy of Soy-Based Formulas in Alleviating Gastrointestinal Symptoms in Infants With Milk-Based Formula Intolerance: A Randomized Clinical Trial

2020 ◽  
pp. 000992282097301
Author(s):  
John B. Lasekan ◽  
Geraldine E. Baggs
Keyword(s):  
Clinical Trial ◽  
Clinical Study ◽  
Randomized Clinical Trial ◽  
Gastrointestinal Symptoms ◽  
Milk Formula ◽  
Term Infants ◽  
Healthy Infants ◽  
Pilot Clinical Study ◽  
Poor Tolerance ◽  
Reference Cohort

A randomized, blinded pilot clinical study was conducted to assess gastrointestinal (GI) tolerance in healthy, full-term infants (2-9 weeks old), whose pediatricians recommended a formula change due to perceived cow’s milk formula intolerance. Infants were randomized and exclusively fed either a commercial control soy formula (SF; n = 22), an experimental partially hydrolyzed SF (10% hydrolyzed, n = 23), or a 5% hydrolyzed SF (n = 26) for 2 weeks. Age-matched reference cohorts (n = 72) with no GI intolerance on milk-based formula were assessed in parallel. Results indicated that all SF-fed groups contributed to reduction ( P < .05) in common GI tolerance symptoms to levels not different from the non-symptomatic reference cohort at study end. The control SF group had more reduced fussiness, gas, and crying and higher formed stools versus hydrolyzed SF groups. In conclusion, the study suggests that SFs reduced GI intolerance symptoms in otherwise healthy infants with poor tolerance on milk-based formulas.

Randomized clinical trial of LigasureTM versus open haemorrhoidectomy

2002 ◽  
Vol 89 (2) ◽  
pp. 154-157 ◽  
Author(s):  
F. F Palazzo ◽  
D. L Francis ◽  
M. A Clifton
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial

Ciprofloxacin is more effective in treating acute pouchitis than metronidazole: A randomized clinical trial

2001 ◽  
Vol 120 (5) ◽  
pp. A453-A453 ◽  
Author(s):  
B SHEN ◽  
J ACHKAR ◽  
B LASHNER ◽  
A ORMSBY ◽  
F REMZI ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial
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