Effects of Elobixibat on Constipation and Lipid Metabolism in Patients With Moderate to End-Stage Chronic Kidney Disease

Objective:The aim of this study was to investigate the effects of elobixibat on constipation and lipid metabolism; and determine the factors associated with the effect of elobixibat on constipation in patients with moderate to end-stage chronic kidney disease (CKD).Methods:Stool frequency and serum lipid parameters were retrospectively analyzed before and after 4 weeks of elobixibat administration in 42 patients (CKD stage G3, 6; stage G4, 9; stage G5, 9; stage G5D, 18). Relationships between the change in stool frequency after initiation of elobixibat and various clinical parameters were analyzed by using linear regression analysis.Results:Elobixibat increased stool frequency from 0.5 ± 0.4 per day to 1.1 ± 0.6 per day (p < 0.001) regardless of whether patients were undergoing dialysis, on concomitant laxatives, or were administered elobixibat before or after breakfast. Elobixibat reduced low-density lipoprotein cholesterol concentration (from 90.9 ± 37.2 mg/dL to 77.5 ± 34.8 mg/dL, p < 0.05) and increased high-density lipoprotein cholesterol concentration (from 44.9 ± 14.3 mg/dL to 57.0 ± 25.8 mg/dL, p < 0.05), but did not change triglyceride concentration. Adverse effects were observed in two patients (nausea and diarrhea). Only phosphate concentration was correlated with the change in stool frequency after initiation of elobixibat (standard coefficient = 0.321, p = 0.043).Conclusions:Elobixibat improved constipation and lipid metabolism in patients with moderate to end-stage CKD, without serious adverse events.

Prebiotic Galacto-Oligosaccharides Impact Stool Frequency and Fecal Microbiota in Self-Reported Constipated Adults: A Randomized Clinical Trial

Constipation is a major issue for 10–20% of the global population. In a double-blind randomized placebo-controlled clinical trial, we aimed to determine a dose-response effect of galacto-oligosaccharides (GOS) on stool characteristics and fecal microbiota in 132 adults with self-reported constipation according to Rome IV criteria (including less than three bowel movements per week). Subjects (94% females, aged: 18–59 years) received either 11 g or 5.5 g of BiotisTM GOS, or a control product, once daily for three weeks. Validated questionnaires were conducted weekly to study primarily stool frequency and secondary stool consistency. At base- and endline, stool samples were taken to study fecal microbiota. A trend towards an increased stool frequency was observed after the intervention with 11 g of GOS compared to control. While during screening everybody was considered constipated, not all subjects (n = 78) had less than three bowel movements per week at baseline. In total, 11 g of GOS increased stool frequency compared to control in subjects with a low stool frequency at baseline (≤3 bowel movements per week) and in self-reported constipated adults 35 years of age or older. A clear dose-response of GOS was seen on fecal Bifidobacterium, and 11 g of GOS significantly increased Anaerostipes hadrus. In conclusion, GOS seems to be a solution to benefit adults with a low stool frequency and middle-aged adults with self-reported constipation.

Clinical and metabolic effects of metaprebiotic therapy for some functional bowel diseases

Aim of investigation: to assess the effectiveness and tolerance of dietary supplements (BAA) STIM and STIM LaxMaterials and methods: The analysis of the treatment of 73 patients who were divided into 2 groups. Group 1-32 patients with functional constipation (8 men and 24 women; mean age — 45.7 ± 12.4 years), Group 2-41 patients with functional diarrhea (19 men and 22 women; mean age — 41.0 ± 15,8 years). The study of clinical symptoms was carried out according to the data of an individual diary, using specialized questionnaires with a scoring of symptoms before and after the course of treatment, before and after treatment, the result of the carbolene test, the content of short-chain fatty acids in the feces was assessed. Tolerability was assessed by recording side effects and adverse events.Monotherapy was carried out with STIM LAX for patients with functional constipation at a dose of 1 tablet 3 times a day for 30 days. STIM for patients with functional diarrhea was prescribed in a dose of 2 tablets 3 times a day for 30 days.Results of the study: The results of the study showed that FC therapy with StimLax effectively reduces the frequency and intensity of symptoms such as difficulty / pain, discomfort during defecation, feeling of incomplete emptying, abdominal pain, time spent in the toilet and the number of failed bowel movements. We observed the normalization of transit time according to the carbolene test and an increase in stool frequency up to 5 times a week.Treatment of patients with FD with Stim led to a significant decrease in the intensity of abdominal pain, rumbling, flatulence, stool frequency, an increase in the time of the carbolene test and the normalization of its consistency.Adverse events were observed in 8 (10.9%) patients (4 patients with FD and 4 patients with FD). On the 3-5th day of treatment, there was an increase in flatulence, rumbling in the abdomen. A temporary decrease in the dose of the drug to 1-2 tablets per day removed these phenomena and the symptoms that appeared were resolved within 1-3 days. After that, the dose of the drug was gradually increased to the initial (effective), which the patients tolerated normally.Conclusions: The results of this study indicate high clinical efficacy and good tolerability of treatment with drugs StimLax and Stim in patients with FC and FD. In some cases, it is necessary to titrate the dose of the drug (downward), but this is not accompanied by a decrease in the effectiveness of therapy. The use of these drugs with metaprebiotic properties helps to modify the microbiota of patients with functional bowel diseases. With constipation, the number and activity of both lactic acid flora and microorganisms that produce butyric acid are stimulated; in addition, calcium lactate is an additional source of butyric acid due to metabolism. With diarrhea, along with the stimulation of the number and activity of the lactic acid flora, there is an improvement in the utilization of butyrate by intestinal cells.

Clinical and Nutritional Impact of a Semi-Elemental Hydrolyzed Whey Protein Diet in Patients with Active Crohn’s Disease: A Prospective Observational Study

Background: Malnourishment is a common complication in patients with Crohn’s disease. Methods: An observational, prospective study was conducted to assess the nutritional status, disease activity, and stool frequency at baseline and after 12 weeks of treatment with a semi-elemental diet in patients with active Crohn’s disease. Results: A total of 144 patients with Crohn’s disease were included. The nutritional status improved after treatment, resulting in 76.1% of patients at low risk of malnourishment, 20.4% moderately malnourished, and 8.5% severely malnourished after 12 weeks of treatment. Nutritional status improvement was associated with the number of nutritional supplements. Mean albumin levels and body mass index (BMI) improved after 12 weeks of nutritional treatment (from 3.0 g/dL to 3.7 g/dL and from 20.2 kg/m2 to 21.1 kg/m2, respectively). A significant decrease in HBI was found after 12 weeks of nutritional treatment (from 10.2 to 3.7). The mean number of stools per day decreased with the 12 week semi-elemental diet (from 4.6 stools/day to 1.7 stools/day). Conclusion: In this observational study, the semi-elemental diet seemed effective in improving the nutritional status, disease activity, and stool frequency in patients with active Crohn’s disease.

Effect of a Mediterranean diet intervention on gastrointestinal function in Parkinson’s disease (the MEDI-PD study): study protocol for a randomised controlled trial

IntroductionConstipation is a common and sometimes debilitating non-motor symptom of Parkinson’s disease (PD) that can result in intestinal inflammation and microbial dysbiosis. The Mediterranean diet, rich in fermentable fibres and anti-inflammatory phenolic compounds, is associated with reduced risk of developing PD and slower progression of parkinsonism. The Mediterranean diet is often recommended for people with PD; however, no studies to date examine this diet as a therapeutic intervention to modulate gastrointestinal (GI) dysfunction.Methods and analysisThis is a randomised, controlled, parallel study. During a 2-week run-in, participants with PD and constipation symptoms (n=52) will undergo baseline nutritional and neurological assessments and provide a stool sample. Participants will be stratified by sex and Hoehn and Yahr stage and randomised to follow standard of care for constipation (control) or standard of care plus a Mediterranean diet (intervention) for 8 weeks. A study dietitian will provide dietary instruction and weekly follow-up via telephone to both groups to support adherence and monitor adverse events. Questionnaires will assess dietary intake and GI function including stool frequency, form, symptoms and laxative usage. Measurements completed at baseline will be repeated at 4 and 8 weeks of the intervention. The primary outcome is to evaluate the difference between mean change (final–baseline) in Gastrointestinal Symptom Rating Scale (GSRS) constipation syndrome scores for the control versus intervention groups. Secondary outcomes will assess stool frequency and form, weekly GSRS syndrome scores, digestive quality of life, laxative usage, faecal microbial communities and inflammatory markers, anxiety, depression, quality life, body weight and composition, dietary fibre intake and Mediterranean diet adherence.Ethics and disseminationThe study has received University of Florida Institutional Review Board-01 approval (IRB202001333). Findings will be disseminated via conference presentations, lectures and peer-reviewed publications.Trial registration numberNCT04683900.

Efficacy of tofacitinib as a «rescue therapy» in patients with severe ulcerative colitis

AIM: to evaluate the effectiveness of tofacitinib as a second line treatment.PATIENTS AND METHODS: the study included 12 patients, 4 (33.34%) males and 8 (66.66%) females. The median age was 41 ± 5 years. All patients admitted to the hospital with a severe flare-up of ulcerative colitis, which was the inclusion criterion in this study. Clinical manifestations, laboratory parameters, and colonoscopy were done at the time of administration of tofacitinib, on days 3 and 7, and after 12 weeks.RESULTS: a fast clinical response on 3 day of treatment, reduction in stool frequency, decrease blood in stool was noted in 10 (83.3%) patients. After 7 days from the start of TFCS therapy, all patients showed a decrease from severe activity to mild activity, as well as a decrease in inflammatory blood markers and hemoglobin levels. During the follow-up for 12 weeks, 100% of patients showed positive clinical and laboratory changes. In 10 (83.4%) patients, remission or maintenance of negligible minimal activity was noted.CONCLUSION: the results obtained show that the use of TFTB in hormone-resistant patients can be effective as a second line of “rescue therapy”.

Efficacy of tofacitinib as a «rescue therapy» in patients with severe ulcerative colitis

AIM: to evaluate the effectiveness of tofacitinib as a second line treatment.PATIENTS AND METHODS: the study included 12 patients, 4 (33.34%) males and 8 (66.66%) females. The median age was 41 ± 5 years. All patients admitted to the hospital with a severe flare-up of ulcerative colitis, which was the inclusion criterion in this study. Clinical manifestations, laboratory parameters, and colonoscopy were done at the time of administration of tofacitinib, on days 3 and 7, and after 12 weeks.RESULTS: a fast clinical response on 3 day of treatment, reduction in stool frequency, decrease blood in stool was noted in 10 (83.3%) patients. After 7 days from the start of TFCS therapy, all patients showed a decrease from severe activity to mild activity, as well as a decrease in inflammatory blood markers and hemoglobin levels. During the follow-up for 12 weeks, 100% of patients showed positive clinical and laboratory changes. In 10 (83.4%) patients, remission or maintenance of negligible minimal activity was noted.CONCLUSION: the results obtained show that the use of TFTB in hormone-resistant patients can be effective as a second line of “rescue therapy”.

To Determine Outcome of Probiotics in Treatment of Acute Diarrhea in Children

Aim: To determine outcome of probiotics in treatment of acute diarrhea in children aged 6 months to 5 years as compared to control Setting: Department of Pediatrics, Khyber Teaching Hospital, Peshawar Duration: From 23 May, 2019 to 23 Nov, 2019 Study design: Randomized Control Trial Methodology: 200 children were divided in two equal groups. Group A were given Probiotics (Saccharomyces boulardii) in a dose of 250-500 mg daily in two divided doses for 5 days, in addition to oral rehydration solution 50-100ml and 100-200ml after each loose stool in child aged <2 years and >5 years respectively. Group B were given only oral rehydration solution in same amount as prescribed to Group A. All the children were followed up at day 4. Outcome was assessed in terms of duration of diarrhea and improvement in number of stools per day at the 5th day of presentation. Results: In Group A, 92(92%) patients showed improvement while in Group B, 71(71%) patients showed improvement. Conclusion: Probiotics are found to be significantly more effective in reducing the stool frequency in ac. diarrhea. Keywords: Acute diarrhea, Probiotic, Saccharomyces boulardii (SB)