Modified-Release Phosphatidylcholine (LT-02) for Ulcerative Colitis: Two Double-Blind, Randomized, Placebo-Controlled Trials.

Background & Aims: The aim of this study was to evaluate the efficacy of LT-02, a novel modified-release phosphatidylcholine (PC) formulation, for induction and maintenance of remission in patients with mild to moderate ulcerative colitis (UC) and inadequate response to mesalamine.

Methods: LT-02 was evaluated in a multicenter double-blind, randomized, placebo-controlled study comprising a 12-week induction trial (PCG-2), followed by a 48-week maintenance trial (PCG-4). In PCG-2, patients were randomized 1:1:1 to treatment with 0.

Evaluation of the Impact of Some Single-Nucleotide Gene Polymorphisms on the Development of Adenomatous Polyps of the Colon in Patients with Irritable Bowel Syndrome.

Background: The number of cases of irritable bowel syndrome is growing worldwide, in which adenomatous polyps can develop as a result of microinflammation of the colonic epithelium. Our study was aimed at the identification of the possible effect of single-nucleotide polymorphisms on the risk of the development of irritable bowel syndrome-related colonic adenomatous polyps.

Materials And Methods: The study involved 187 irritable bowel syndrome patients.

Gastrointestinal health: changes of intestinal mucosa and microbiota in patients with ulcerative colitis and irritable bowel syndrome from PM-polluted regions of Ukraine.

Here, clinical studies of patients were conducted to assess changes in patients with ulcerative colitis (UC) and irritable bowel syndrome (IBS) associated with air pollution by PM. A comparative study of 100 patients with UC and 75 with IBS from highly (HPRs) and low (LPRs) PM-polluted regions of Ukraine was conducted. Biopsy of the intestinal mucosa of patients with UC from HPRs showed severe cellular infiltration.

Budesonide Suppositories Are Effective and Safe for Treating Acute Ulcerative Proctitis.

Background & Aims: Although proctitis is the most limited form of ulcerative colitis, it causes unpleasant symptoms. Topical mesalamine, the standard treatment, is not always effective. We conducted a randomized phase 2 trial to determine the efficacy and safety of 2 doses of a budesonide suppository vs mesalamine suppositories vs combined budesonide and mesalamine suppositories for proctitis.

Efficacy and safety of a novel high-dose mesalazine tablet in mild to moderate active ulcerative colitis: a double-blind, multicentre, randomised trial.

Background: Adherence to mesalazine treatment is essential for the successful treatment of ulcerative colitis.

Objective: The objective of this study was to compare the efficacy, safety and preference of a novel high-dose 1000 mg mesalazine tablet versus conventional treatment for ulcerative colitis remission.

Methods: This pivotal phase III trial compared one 1000 mg mesalazine tablet (M1000 group) versus two registered 500 mg mesalazine tablets (M2x500 group), both taken three times daily, in patients with mild to moderately active ulcerative colitis.

Once versus three times daily dosing of oral budesonide for active Crohn's disease: a double-blind, double-dummy, randomised trial.

Background: Oral budesonide 9 mg/day represents first-line treatment of mild-to-moderately active ileocolonic Crohn's disease. However, there is no precise recommendation for budesonide dosing due to lack of comparative data. A once-daily (OD) 9 mg dose may improve adherence and thereby efficacy.

Clinical, endoscopical and morphological efficacy of mesalazine in patients with irritable bowel syndrome.

Objectives: The aim of this study was to analyze the clinical efficacy and cytomorphologic changes of colon mucosa following the treatment of patients suffering from irritable bowel syndrome (IBS) with mesalazine (5-aminosalicylic acid [5-ASA]).

Methods: In this controlled, randomized, blind clinical trial, a total of 360 patients with varying subtypes of IBS were randomly treated with 500 mg of mesalazine qid or by standard therapy without mesalazine for a period of 28 days. Pre- and post-treatment pain intensity, pain duration, meteorism, stool abnormalities and endoscopic parameters were monitored, and biopsies or brush biopsies were examined histologically.

3g mesalazine granules are superior to 9mg budesonide for achieving remission in active ulcerative colitis: a double-blind, double-dummy, randomised trial.

Background And Aims: Budesonide may be an effective therapy for mild-to-moderately active ulcerative colitis (UC). This study aimed to demonstrate non-inferiority for oral 9mg budesonide once daily (OD) versus 3g mesalazine granules OD.

Methods: This was an eight-week randomised, double-blind, double-dummy, multicentre study in which patients with mild-to-moderately active UC, defined as Clinical Activity Index (CAI) ≥6 and Endoscopic Index (EI) ≥4, received budesonide (Budenofalk® 3mg capsules×3) or mesalazine (Salofalk® 1000mg granules×3).

Clinical trial: a novel high-dose 1 g mesalamine suppository (Salofalk) once daily is as efficacious as a 500-mg suppository thrice daily in active ulcerative proctitis.

Background: Mesalamine suppositories are first-line therapy in active ulcerative proctitis; the standard regime still recommends multiple doses per day. The primary objective of this study was to show the noninferiority of once-daily administration of a novel 1 g mesalamine suppository versus thrice-daily administration of the 0.5 g mesalamine suppository.

Prevention of recurrent lower urinary tract infections by long-term administration of fosfomycin trometamol. Double blind, randomized, parallel group, placebo controlled study.

Three hundred and seventeen non pregnant females, suffering of recurrent lower urinary tract infections (UTIs; at least three episodes in the preceding 12 months) were enrolled in a double blind, randomized placebo (PL) controlled, parallel group clinical study, addressed to evaluate the efficacy and safety of fosfomycin trometamol (CAS 78964-85-9, FT, Monuril) in the prevention of infectious recurrences of lower urinary tract. One hundred and sixty six and 151 patients were allocated at random to FT or to PL treatment. The assigned treatment, i.

Biochemical and heart adaptations to physical training and supplementation with amino acids.

This study evaluated the role of amino acids supplementation on the heart's adaptation under extensive training conditions. Sixty active athletes (bicyclists and swimmers) were separated into 2 groups: 30 were given amino acid mixture (1 g per 10 kg of body weight) for a period of 1 month, and the other 30 were given placebo for the same duration (control group). In the same time period, 20 subjects of similar age not engaged in physical training or sports activities were used as the additional control group.