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Hepatic encephalopathy (HE) is associated with poor prognosis in cirrhosis. Drugs used in the treatment of HE are primarily directed at the reduction of the blood ammonia levels. Rifaximin and lactulose have shown to be effective in HE. We evaluated the efficacy and safety of rifaximin plus lactulose vs. lactulose alone for treatment of overt HE. In this prospective double-blind randomized controlled trial, 120 patients with overt HE were randomized into two groups: (group A lactulose plus rifaximin 1,200 mg/day; n=63) and group B (lactulose (n=57) plus placebo). The primary end point was complete reversal of HE and the secondary end points were mortality and hospital stay. A total of 120 patients (mean age 39.4±9.6 years; male/female ratio 89:31) were included in the study. 37 (30.8%) patients were in Child-Turcotte-Pugh (CTP) class B and 83 (69.2%) were in CTP class C. Mean CTP score was 9.7±2.8 and the MELD (model for end-stage liver disease) score was 24.6±4.2. At the time of admission, 22 patients (18.3%) had grade 2, 40 (33.3%) had grade 3, and 58 (48.3%) had grade 4 HE. Of the patients, 48 (76%) in group A compared with 29 (50.8%) in group B had complete reversal of HE (P<0.004). There was a significant decrease in mortality after treatment with lactulose plus rifaximin vs. lactulose and placebo (23.8% vs. 49.1%, P<0.05). There were significantly more deaths in group B because of sepsis (group A vs. group B: 7:17, P=0.01), whereas there were no differences because of gastrointestinal bleed (group A vs. group B: 4:4, P=nonsignificant (NS)) and hepatorenal syndrome (group A vs. group B: 4:7, P=NS). Patients in the lactulose plus rifaximin group had shorter hospital stay (5.8±3.4 vs. 8.2±4.6 days, P=0.001). Combination of lactulose plus rifaximin is more effective than lactulose alone in the treatment of overt HE.

Background The study aimed to assess the efficacy and safety of Natamycin + Lactulose vaginal suppositories (100 mg natamycin and 300 mg lactulose) (AVVA RUS JSC, Russia) in adult females with vulvovaginal candidiasis. Methods and Results An international, randomized, controlled, assessor-blinded clinical trial enrolled 218 females randomly distributed into three groups: Natamycin + Lactulose (92 patients), Lactulose (36 patients), and Pimafucin® (90 patients). The study drug and comparator drugs had an identical dosing regimen (one suppository intravaginally once a day at bedtime for six days). The study involved four visits to the study site with examination at Visits 2 and 3. The fixed-dose combination of Natamycin + Lactulose was superior to both comparator drugs in terms of the primary efficacy endpoint defined as the percentage of patients achieving a clinical recovery: the absence of symptoms of vulvovaginal candidiasis. At Visit 2, clinical recovery was reported in 81.6% of females in the Natamycin + Lactulose group compared to 42.9% and 62.3% of patients in the Lactulose and Pimafucin groups, respectively. The difference in proportions was 38.8% and 18.4%. In the Natamycin + Lactulose group, microscopic recovery was observed in 75.9% of patients at Visit 2 and in 90.8% of patients at Visit 3. In the Lactulose group, 45.7% and 74.3% subjects responded positively at Visits 2 and 3. In Pimafucin group, microscopic recovery was reported in 71.3% and 88.5% of patients at Visits 2 and 3, respectively, while no differences were observed between the Natamycin + Lactulose and Pimafucin groups at both visits. At Visit 3, the number of vaginal lactobacilli was significantly higher in the Natamycin + Lactulose group. In females with the low baseline content of vaginal lactobacilli, the combination drug under investigation increased the vaginal lactobacilli content to the reference values in 15.4% and 20.9% of patients at Visit 2 and Visit 3, respectively. Conclusions The fixed-dose combination Natamycin + Lactulose 100 mg + 300 mg vaginal suppositories (AVVA RUS JSC, Russia) demonstrated superior efficacy compared to 1) Pimafucin 100 mg and 2) Lactulose 300 mg vaginal suppositories in adult females with vulvovaginal candidiasis. Trial registration NCT06411314, retrospectively registered on May, the 13th, 2024.

Lactulose mannitol ratio tests are clinically useful for assessing disorders characterised by changes in gut permeability and for assessing mixing in the intestinal lumen. Variations between currently used test protocols preclude meaningful comparisons between studies. We determined the optimal sampling period and related this to intestinal residence. Half-hourly lactulose and mannitol urinary excretions were determined over 6 hours in 40 healthy female volunteers after administration of either 600 mg aspirin or placebo, in randomised order at weekly intervals. Gastric and small intestinal transit times were assessed by the SmartPill in 6 subjects from the same population. Half-hourly percentage recoveries of lactulose and mannitol were grouped on a basis of compartment transit time. The rate of increase or decrease of each sugar within each group was explored by simple linear regression to assess the optimal period of sampling. The between subject standard errors for each half-hourly lactulose and mannitol excretion were lowest, the correlation of the quantity of each sugar excreted with time was optimal and the difference between the two sugars in this temporal relationship maximal during the period from 2½-4 h after ingestion. Half-hourly lactulose excretions were generally increased after dosage with aspirin whilst those of mannitol were unchanged as was the temporal pattern and period of lowest between subject standard error for both sugars. The results indicate that between subject variation in the percentage excretion of the two sugars would be minimised and the differences in the temporal patterns of excretion would be maximised if the period of collection of urine used in clinical tests of small intestinal permeability were restricted to 2½-4 h post dosage. This period corresponds to a period when the column of digesta column containing the probes is passing from the small to the large intestine.

In recent years, research has focused on the use of dietary fibers and prebiotics, since many of these polysaccharides can be metabolized by intestinal microbiota, leading to the production of short-chain fatty acids. The metabolites of prebiotic fermentation also show anti-inflammatory and immunomodulatory capabilities, suggesting an interesting role in the treatment of several pathological conditions. Galacto-oligosaccharide and short- and long-chain fructans (Fructo-oligosaccharides and inulin) are the most studied prebiotics, even if other dietary compounds seem to show the same features. There is an increasing interest in dietary strategies to modulate microbiota. The aim of this review is to explore the mechanisms of action of prebiotics and their effects on the principal gastro-intestinal disorders in adults, with a special focus on Galacto-oligosaccharides, Fructo-oligosaccharides, lactulose and new emerging substances which currently have evidence of prebiotics effects, such as xilooligosaccharides, soybean oligosaccharides, isomaltooligosaccharides, lactobionic acid, resistant starch and polyphenols.

In the present double-blind randomised study, the efficacy of combination of Bacillus coagulans Unique IS2 and lactulose was evaluated in the treatment of functional constipation in adults. One-fifty participants diagnosed with functional constipation (Rome III criteria) were randomised (1:1:1) and supplemented daily with 15 mL suspension of probiotic ( B. coagulans Unique IS2, 2 × 10 9 spores) with lactulose (10 g) (group 1) or lactulose (10 g) (group 2) or placebo (water) (group 3) for 4 weeks. The primary (stool frequency) and secondary outome measures (stool consistency, sensation of incomplete evacuation, defecation- and abdominal-pain) were recorded weekly for up to 4 weeks. Bacillus coagulans Unique IS2 with lactulose showed significant changes in stool frequency as compared to lactulose treatment; however, at the end of the trial, it was found insignificant due to the gradual increase of stool frequency score of lactulose treatment. The changes observed in stool consistency were early (2nd week) and remained consistent up to end of the trial. The significant reduction of sensation of incomplete evacuation, defecation-, and abdominal-pain correlated with the strains ability to produce short-chain fatty acids. No adverse events were observed in any of the groups, and all the vital parameters were normal during the course of the study. Overall, results indicated that B. coagulans Unique IS2 addition to lactulose reduced time required to relieve constipation as compared to lactulose alone. In conclusion, B. coagulans Unique IS2 with lactulose is more effective than lactulose alone to relieve symptoms of constipation in a shorter period. Trial registration: CTRI/2018/11/016399, dated 22/11/2018.

Lactic acid bacteria (LAB) constitute the microbial group most used as probiotics; however, many strains reduce their viability during their transit through the body. The objective of this study was to evaluate the effect of two microencapsulation techniques, as well as the incorporation of lactulose as a prebiotic and the use of chitosan coating on the microcapsules, on the viability of the Lactobacillus sp. strain FM4.C1.2. LAB were microencapsulated by extrusion or emulsion, using 2% sodium alginate as encapsulating matrix and lactulose (2 or 4%) as the prebiotic. The encapsulation efficiency was evaluated, and the capsules were measured for moisture and size. The encapsulation efficiency ranged between 80.64 and 99.32% for both techniques, with capsule sizes between 140.64 and 1465.65 µm and moisture contents from 88.23 to 98.04%. The microcapsules of some selected treatments (five) were later coated with chitosan and LAB survival was evaluated both in coated and uncoated microcapsules, through tolerance to pH 2.5, bile salts and storage for 15 days at 4 °C. The highest survival of the probiotic strain under the conditions of pH 2.5 (96.78–99.2%), bile salts (95.54%) and storage for 15 days (84.26%), was found in the microcapsules obtained by emulsion containing 4% lactulose and coated with chitosan. These results demonstrate the possible interaction of lactulose with alginate to form better encapsulating networks, beyond its sole probiotic effect. Additional research may shed more light on this hypothesis.

Background Polyethylene glycol electrolyte solution (PEG-ELS) is the standard for bowel preparation but often suffers from poor patient compliance and tolerability due to its high-volume requirement. This prospective, single-blinded, non-inferiority, randomized control trial aims to investigate the efficacy and safety of a lactulose-based regimen as an alternative for bowel preparation. Methods Two hundred nine patients were randomly allocated to receive either a combination regimen consisting of 133.4 g lactulose in 200 mL, 800 mL carbohydrate-containing clear liquid, 2L additional water, and 5 g simethicone (n = 104) or 3L PEG-ELS with 5 g simethicone (n = 105), both administered in a split-dose format. The primary outcome was the rate of adequate bowel preparation, measured by the Boston bowel preparation score (BBPS). Adequate bowel preparation was defined as a BBPS score of 2 or 3 in all colon segments. Secondary outcomes included the percentage of high-quality bowel preparation (defining as a total BBPS score of 8 or 9), polyp detection rate (defining as the percentage of procedures where at least one polyp was detected), willingness to repeat the bowel preparation, adverse events, and changes in blood glucose and electrolyte levels. Results The rate of adequate bowel preparation (96.2% vs. 97.1%, p = 0.691), the percentage of high-quality preparation (62.5% vs. 66.7%, p = 0.529), average total BBPS scores (p = 0.607), polyp detection rates (66.3% vs. 77.1%, p = 0.083), and tolerability and acceptability outcomes, including satisfaction (p = 0.729) and willingness to repeat preparation (p = 0.744), were not statistically different between the two arms. Adverse events and changes in blood glucose and electrolytes showed no significant differences (all p > 0.05). Conclusion The combination of oral lactulose and carbohydrate-containing clear fluids was non-inferior to 3L PEG-ELS for bowel preparation adequacy and polyp detection, without statistically significant differences in terms of tolerability and safety.

Background Pakistan has a high prevalence of HCV and HBV, causing cirrhosis, leading to hepatic encephalopathy in approximately 30–45% of cirrhotic patients. Overt hepatic encephalopathy (OHE) is a serious type of hepatic encephalopathy that refers to brain dysfunction resulting from acute or chronic liver disease. Patients present flapping tremors and mental alterations leading to a coma, which disrupts daily activities and patient health-related quality of life. OHE can be treated by lactulose, rifaximin, probiotics, and l -ornithine l -aspartate (LOLA). Lactulose (controlled drug for trial) is the main treatment for OHE, even though its effectiveness in clinical trials has remained varied. Rifaximin (interventional drug), probiotics (interventional drug), and LOLA (interventional drug) all showed a significant effect in reducing the grade of hepatic encephalopathy, lowering blood ammonia levels, and enhancing psychomotor function in OHE patients. Our trial aims to determine the most effective treatment combination, as despite the availability of multiple treatment options, the efficacy is still uncertain. Limited studies have compared individual treatments, but no research has been conducted to assess all four treatment groups together, i.e., Group A (lactulose) as the control group, Group B (rifaximin + lactulose), Group C (probiotics + lactulose), and Group D (LOLA + lactulose). Methods This trial is a single-center, parallel, multi-arm, randomized, unblinded, lactulose-controlled clinical trial. A total of 252 patients (both male and female aged 18–80 years), 63 in each treatment group, will be recruited in the study from the time of participation in the trial until the end of treatment (days 1–5). Primary outcome is to assess grade reversal of OHE on day 5 of trial participation. The secondary outcome is to determine the length of hospital stay and recovery time (days), monitoring of adverse drug reactions and death by cause in OHE patients. Discussion This randomized controlled trial protocol will compare the efficacy of four proposed groups of medications to fill the gap in current knowledge. Trial registration Chinese Clinical Trial Registry ChiCTR2300075925, registered on 19 September 2023; ClinicalTrials.gov NCT07037394, registered on 24 June 2025. Released to the public on 26 June 2025.

Objective The aim of this study was to evaluate the therapeutic effects of transcutaneous electrical nerve stimulation (TENS) on opioid-induced constipation (OIC) and patient quality of life. Methods A total of 251 patients were randomly allocated to a treatment group, who received TENS and oral lactulose solution (n = 124), and a control group, who received only oral lactulose solution (n = 127). Constipation and quality of life after treatment were measured by comparing semiquantitative scores based on subjective symptoms. Results The defecation difficulty, incomplete defecation feeling, and overall defecation satisfaction scores of the treatment group were significantly different from those of the control group (P = 0.018). Bowel Function Index and quality of life scores of the treatment group were significantly greater than those of the control group. The effective rates of control and treatment groups were 85.8% and 91.9%, respectively. Conclusion TENS of relevant acupuncture points significantly relieved the clinical symptoms of constipation of patients with OIC and improved their quality of life.

BackgroundDuodenal aspiration (DA) and lactulose breath tests (LBT) are commonly performed to diagnose small intestinal bacterial overgrowth (SIBO). There are no data directly comparing these tests.AimsTo investigate the agreement between DA and LBT for the diagnosis of SIBO.MethodsA retrospective cohort study of adult patients who underwent a LBT and a DA at a tertiary care center over 9 years was assembled. LBT was considered positive if the hydrogen baseline or peak change measurement was ≥ 20 ppm, and/or if the methane baseline or peak change was ≥ 10 ppm. DA was considered positive if > 100,000 cfu/mL of gram-negative flora was identified on culture, and contaminated if > 100,000 cfu/mL of gram-positive flora was identified.ResultsA total of 106 patients were evaluated; 81 (76.4%) were female; the mean age was 53.4 ± 15.9 years. 21 patients (19.8%) had evidence of contamination on DA. 14 (16.5%) patients had a positive DA result. Patients with diabetes mellitus and those with PPI use were more likely to have a positive DA (94.4% vs. 71.4%, p = 0.007; 62% vs. 28.6%, p = 0.021, respectively). 33 (31.1%) patients had a positive LBT. Patients with a history of small bowel resection were more likely to have a positive LBT (12.1% vs. 1.4%, p = 0.016). DA and LBT results agreed in 54 patients (63.5%; kappa = − 0.02), indicating poor agreement.ConclusionsThe agreement between LBT and DA in evaluation for SIBO was poor. LBT may be favorable to DA, as LBT is safer, cheaper, and less likely to yield a contaminant result.