Magnetic Resonance Imaging Reveals Novel Insights into the Dual Mode of Action of Bisacodyl: A Randomized, Placebo-controlled Trial in Constipation.

Bisacodyl is a widely used laxative that stimulates both motility and secretion. Our aim was to exploit the unique capabilities of MRI to define bisacodyl's mode of action. Two placebo-controlled cross-over trials were performed, one using a single dose of Bisacodyl 5 mg while the second dosed daily for 3 consecutive days.

Essential phospholipids impact cytokine secretion and alter lipid-metabolizing enzymes in human hepatocyte cell lines.

Background: Essential phospholipids (EPL) are hepatoprotective.

Methods: The effects on interleukin (IL)-6 and -8 secretion and on certain lipid-metabolizing enzymes of non-cytotoxic concentrations of EPL (0.1 and 0.

Bioequivalence of 2 Pediatric Formulations of Fexofenadine Hydrochloride Oral Suspension.

Fexofenadine hydrochloride (HCl) is a second-generation, nonsedating, histamine H1-receptor antagonist used to manage seasonal allergic rhinitis and chronic idiopathic urticaria. A new oral pediatric suspension of fexofenadine HCl has been developed, with the preservative potassium sorbate replacing parabens. The objective of this phase 1 single-center, open-label, randomized, 2-treatment, full-replicated, 4-period, 2-sequence crossover study in healthy adult volunteers was to assess the bioequivalence of 30 mg of the new oral suspension of fexofenadine HCl (test) versus 30 mg of the marketed pediatric oral suspension of fexofenadine HCl (reference).

Analysis of the microbial content of probiotic products commercialized worldwide and survivability in conditions mimicking the human gut environment.

Introduction: Probiotics are living microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Adequate number of living microbes, the presence of specific microorganisms, and their survival in the gastrointestinal (GI) environment are important to achieve desired health benefits of probiotic products. In this study, 21 leading probiotic formulations commercialized worldwide were evaluated for their microbial content and survivability in simulated GI conditions.

A Retrospective Real-World Observational Study Assessing the Evolution of Bisacodyl Prescriptions in Patients with Constipation During Long-Term Treatment.

Background: Potential habituation could be a safety concern associated with the long-term use of bisacodyl in patients with constipation.

Objective: In this study, we evaluated whether patients with constipation who require long-term treatment with bisacodyl will remain on a stable dose when treated for ≥ 28 days.

Methods: In this retrospective, population-based, observational cohort study, electronic medical record data of adult patients with constipation between January 1, 2011, and December 31, 2019, were collected from The Health Improvement Network French database.

Essential phospholipids decrease apoptosis and increase membrane transport in human hepatocyte cell lines.

Background: Essential phospholipids (EPL) have hepatoprotective effects across many liver diseases/conditions. The impact of EPL on hepatocyte function in vitro was investigated.

Methods: Effects of noncytotoxic concentrations of EPL (0.

Reduced Self-Perception of Fatigue after Intake of Root Extract (G115) Formulated with Vitamins and Minerals-An Open-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 combined with vitamins and minerals could alleviate fatigue, this open label study aimed at assessing its effect on perceived fatigue and energy.

Effect of magnesium and vitamin B6 supplementation on mental health and quality of life in stressed healthy adults: Post-hoc analysis of a randomised controlled trial.

Magnesium status and vitamin B6 intake have been linked to mental health and/or quality of life (QoL). In an 8-week Phase IV randomised controlled study in individuals with low magnesemia and severe/extremely severe stress but who were otherwise healthy, greater stress reduction was achieved with magnesium combined with vitamin B6 than with magnesium alone. We present a previously unreported secondary analysis of the effect of magnesium, with and without vitamin B6, on depression, anxiety, and QoL.

Kinetics of Intestinal Presence of Spores Following Oral Administration of Bacillus clausii Formulations: Three Single-Centre, Crossover, Randomised, Open-Label Studies.

Unlabelled: BACKGROUND AND OBJECTIVE: Probiotics are live microorganisms that may provide benefits including the prevention of gastrointestinal disorders and other diseases. Enterogermina is a probiotic mix of spores from four strains of Bacillus clausii (O/C, T, N/R and SIN), available in several oral formulations. The objective of this analysis was to evaluate and compare the kinetic profiles of different formulations of Enterogermina-vial [E4 once daily (OD) and E2 twice daily (BID)], capsule [EC2 three times daily (TID)], oral powder for suspension (ES6 OD) and oral powder not requiring suspension (E6 OD) from two studies from 2012 (EUDRACT 2010-024497-19 and 2010-023187-41) and one study from 2016 (EUDRACT 2015-003330-27).

A novel digital approach to describe real world outcomes among patients with constipation.

Understanding day-to-day variations in symptoms and medication management can be important in describing patient centered outcomes for people with constipation. Patient Generated Health Data (PGHD) from digital devices is a potential solution, but its utility as a tool for describing experiences of people with frequent constipation is unknown. We conducted a virtual, 16-week prospective study of individuals with frequent constipation from an online wellness platform that connects mobile consumer digital devices including wearable monitors capable of passively collecting steps, sleep, and heart rate data.

Safety and Tolerability of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart (NovoLog) When Used in Insulin Pumps in Adults with Type 1 Diabetes: A Randomized, Open-Label Clinical Trial.

The aim was to assess the safety and tolerability of the insulin aspart biosimilar/follow-on product SAR341402 (100 U/mL solution; SAR-Asp) and originator insulin aspart (100 U/mL; NN-Asp; NovoLog) self-administered through an insulin pump. This randomized, open-label, 2 × 4-week crossover study enrolled 45 adults with type 1 diabetes (T1D). Participants were randomized 1:1 to the treatment sequence SAR-Asp/NN-Asp or NN-Asp/SAR-Asp.

Safety and efficacy of abobotulinumtoxinA for hemiparesis in adults with upper limb spasticity after stroke or traumatic brain injury: a double-blind randomised controlled trial.

Background: Resistance from antagonistic muscle groups might be a crucial factor reducing function in chronic hemiparesis. The resistance due to spastic co-contraction might be reduced by botulinum toxin injections. We assessed the effects of abobotulinumtoxinA injection in the upper limb muscles on muscle tone, spasticity, active movement, and function.

[Estimating emergency hospital admissions to gauge short-term effects of air pollution: evaluation of health data quality].

The study of the short-term effects and health impact of air pollution is carrier out by the ERPURS regional surveillance program which utilizes hospitalization data obtained from the French hospital information system (PMSI) to determine these links. This system does not permit the distinction between emergency hospital admissions from scheduled ones, which cannot be related to short term changes in air pollution levels. This study examines how scheduled admissions affect the quality of the health indicators used to estimate air pollution effects.