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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.

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 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.

INTRODUCTION:Colonoscopy is currently considered as one of the principal techniques to diagnose the colorectal diseases. Admittedly, qualified bowel preparation before colonoscopy is a premise for high-quality examination. Lower quality bowel preparation might seriously impede visualization of the intestinal mucosa, resulting in missed and misdiagnosed intestinal lesions. Therefore, it is necessary to choose the appropriate oral laxative based on the guarantee of safety and efficacy.METHODS:This prospective randomized controlled study was conducted to compare lactulose oral solution and polyethylene glycol (PEG) electrolyte powder for bowel preparation using the following indicators: Boston Bowel Preparation Scale, Bowel Bubble Score, detection rate of adenoma and lesion, patients' satisfaction, and adverse effects. Our study investigated the suitability of 2 bowel preparation reagents for patients with different body mass indices mainly based on body mass index (BMI).RESULTS:In the lactulose group, there was a significant improvement in the quality of bowel preparation compared with those in the PEG group (P < 0.05), especially in people with normal BMI and higher BMI. Compared with the PEG group, individuals in the lactulose group had a significantly higher adenoma detection rate (50% vs 33.5%, P < 0.05) and taste scores (8.82 vs 6.69, P < 0.05), as well as significantly fewer adverse reactions (6.5% vs 32.5%, P < 0.05).DISCUSSION:Lactulose oral solution is superior to PEG in bowel preparation quality and taste, especially in normal BMI and higher BMI groups. It can be used clinically as a potential and promising bowel preparation agent in the future. Clinical Trial registration number: ChiCTR2100054318.

To assess the effectiveness of partially hydrolyzed guar gum (PHGG) in improving constipation and reducing the use of laxatives among long term care facility (LTCF) residents. A single-center, prospective, randomized, placebo-controlled, single-blinded parallel-group trial from September 2021 to November 2021. Four LTCF in Hong Kong. Fifty-two LTCF residents with chronic constipation (mean age: 83.9±7.6 years, male 38%). 5g PHGG mixed with 200ml water per day for 4 weeks was given to intervention group participants. Control group received 200ml water for 4 weeks. Participants continued their usual as-needed laxative (lactulose, senna or dulcolax) on their own initiative. Baseline measurements included age, gender, Charlson comorbidity index, Roackwood’s Clinical Frailty Scale, body mass index and daily dietary fiber intake. Outcome measures were fecal characteristics assessed by Bristol Stool Form Scale, bowel opening frequency and laxative use frequency at baseline, first, second, third and fourth week of trial. Adverse events were measured. The study was registered on ClinicalTrial.gov; identifier: NCT 05037565. There was no significant difference in bowel frequency and stool characteristics between the treatment group and control group. However, there was a significantly lower frequency of lactulose, senna, and total laxative use in the treatment group compared with controls in the third and fourth week. There was no significant difference in adverse effects between the two groups. This study showed that daily dietary fibre supplementation by using PHGG for 4 weeks in LTCF residents results in significantly less laxative use than placebo. It may be an effective way to reduce laxative dependence among older people living in LTCFs.

To assess the tolerance and potential nutritional consequences of long-term repeated doses of PEG 4000 (10 to 30 g/day) in elderly patients with chronic constipation as compared to lactulose (10-30 g/ day). Single blind, randomised, multicentre, parallel group comparative study. Community-dwelling patients and nursing homes residents aged 70 years and older with a history of chronic constipation. PEG 4000 (10-30 g/day) or lactulose (10-30 g/day) for six months. Clinical nutritional status (Mini Nutritional Assessment), blood and stool samples were taken at baseline and after three and six months for assay of nutritional and absorption parameters. A patient diary documented digestive symptoms and adverse events were recorded. Information on efficacy (stool frequency and consistency) was collected as a secondary outcome measure. Of the 316 patients screened, 245 eligible patients constituted the ITT population (PEG 4000: N = 118; lactulose group: N = 127). The proportion of patients receiving PEG 4000 with abnormal levels of electrolytes, nutritional markers or vitamins did not significantly change in the six months after initiating laxative treatment and do not differ between the two groups. After a D-xylose challenge test, the proportion of patients with abnormally low xylosaemia (suggesting malabsorption) varied from 24.6% at baseline to 35.8% after six months in the PEG 4000 group and from 29.1% to 42.4% in the lactulose group, with no significant between-group or within-group differences. The proportion of patients with poor nutritional status (MNA score <17) varied from 8.5% at baseline to 9.8% after 6 months in the PEG 4000 group and from 3.9% to 5.0% in the lactulose group. No changes in stool fat or total or soluble stool nitrogen were observed in the minority of patients for whom stool analysis was performed. A significantly higher stool frequency p <0.05) and improved stool consistency p <0.05) was observed in the PEG 4000 group compared to the lactulose group at each monthly evaluation period. After six months of treatment with PEG 4000, no clinically relevant changes in biochemical and nutritional parameters and no unanticipated treatment-related adverse events were detected, demonstrating the good clinical tolerance of PEG 4000 in this population of elderly constipated patients. This tolerance was associated with a better clinical efficacy of PEG 4000 compared to lactulose.

Background: Recently, polyethylene glycol (PEG 3350) has been suggested as a good alternative laxative to lactulose as a treatment option in paediatric constipation. However, no large randomised controlled trials exist evaluating the efficacy of either laxative. Aims: To compare PEG 3350 (Transipeg: polyethylene glycol with electrolytes) with lactulose in paediatric constipation and evaluate clinical efficacy/side effects. Patients: One hundred patients (aged 6 months–15 years) with paediatric constipation were included in an eight week double blinded, randomised, controlled trial. Methods: After faecal disimpaction, patients <6 years of age received PEG 3350 (2.95 g/sachet) or lactulose (6 g/sachet) while children ⩾6 years started with 2 sachets/day. Primary outcome measures were: defecation and encopresis frequency/week and successful treatment after eight weeks. Success was defined as a defecation frequency ⩾3/week and encopresis ⩽1 every two weeks. Secondary outcome measures were side effects after eight weeks of treatment. Results: A total of 91 patients (49 male) completed the study. A significant increase in defecation frequency (PEG 3350: 3 pre v 7 post treatment/week; lactulose: 3 pre v 6 post/week) and a significant decrease in encopresis frequency (PEG 3350: 10 pre v 3 post/week; lactulose: 8 pre v 3 post/week) was found in both groups (NS). However, success was significantly higher in the PEG group (56%) compared with the lactulose group (29%). PEG 3350 patients reported less abdominal pain, straining, and pain at defecation than children using lactulose. However, bad taste was reported significantly more often in the PEG group. Conclusions: PEG 3350 (0.26 (0.11) g/kg), compared with lactulose (0.66 (0.32) g/kg), provided a higher success rate with fewer side effects. PEG 3350 should be the laxative of first choice in childhood constipation.

Background: It has been reported that adequate calcium intake decreases body fat and appropriate intakes of magnesium suppress the development of the metabolic syndrome. Furthermore, lactulose increases the absorption of calcium and magnesium. An optimal combination of calcium, magnesium and lactulose may therefore reduce body fat mass. Methods: An open-label randomized controlled trial was conducted to investigate the body fat-reducing effects of a test food containing 300 mg calcium, 150 mg magnesium, and 4.0 g lactulose. Body composition parameters and blood hormone and urine mineral concentrations were measured at baseline and at 6 and 12 months thereafter. Whole-body fat mass was measured with dual-energy x-ray absorptiometry. Results: Seventy- six middle-aged Japanese women (47.5+/-4.7 years) were randomized to the intake group (n=48) or the non-intake control group (n=28). At 12 months the difference in body fat mass change between the two groups (intake group - control group) was -0.8 kg (95% CI: -1.5 - 0.0 kg, p=0.046), although there were no differences in anthropometric data between the two groups. Body fat percentage at 12 months tended to be lower in the intake group, but the difference was not significant (p=0.09). Conclusions: These findings may suggest that calcium in combination with magnesium and lactulose can reduce body fat mass in middle-aged Japanese women. However, the contribution of magnesium and lactulose are unclear in this study. Further studies are needed to clarify these contributions.

BackgroundClinical evidence of lactulose for chronic constipation in Japan was lacking. We performed a randomized, double-blind, placebo-controlled, dose-finding study in Japanese patients with chronic constipation to estimate the optimal clinical dose of lactulose.MethodsOverall, 250 patients were randomized to receive SK-1202 (13, 26, or 39 g/day, as crystalline lactulose dosage) or placebo twice daily (morning and evening) orally for 2 weeks. The primary endpoint was the change from baseline frequency of spontaneous bowel movements (SBMs) at Week 1. The secondary endpoints included the change from baseline of SBMs at Week 2, percentage of patients experiencing SBM within 24 and/or 48 h of the initial dose, stool consistency, and constipation severity, and adverse events were also evaluated.ResultsThe 26 and 39 g/day of SK-1202 induced significantly and dose-dependently more increase in SBM at Week 1 than placebo (p = 0.003, p < 0.001). These groups also showed significant improvements in the secondary endpoints. There were no significant differences in the incidence of adverse drug reactions (ADRs) between the placebo and SK-1202 groups. Gastrointestinal disorder was the most common ADR, and diarrhea developed in 6 patients (9.7%) treated with 39 g/day; however, the symptoms were mild in severity and resolved after follow-up, dose reduction, or dose suspension. SK-1202 was generally well tolerated up to 39 g/day.ConclusionOur results suggest that SK-1202 is useful in Japanese patients with chronic constipation, and optimal dose of SK-1202 is 26 g/day.

Rifaximin and lactulose are common effective agents for hepatic encephalopathy (HE). Whether a combination of rifaximin and lactulose improves the efficacy and mortality in patients with HE compared with lactulose alone needs to be analyzed. A systematic search was performed in electronic databases and other sources for possible studies focusing on combination therapy of rifaximin and lactulose for HE between January 2000 and February 2018. A meta-analysis was performed by the method recommended by the Cochrane Collaboration, and estimated effect size was presented as risk difference (RD), 95% CI, and the number needed to treat (NNT). Subgroup analysis, sensitivity analysis, and Trial Sequence Analysis were comprehensively performed to indicate the source of heterogeneity and risk of bias. Five randomized and five observational studies involving 2,276 patients were included. Combination therapy had a significant advantage in both clinical efficacy increase (RD 0.26, 95% CI 0.19-0.32, NNT 5) and mortality decrease (RD -0.16, 95% CI -0.20-0.11, NNT 9) in overall analysis. In the pooled analysis of randomized studies, combination therapy showed similar results in clinical efficacy (RD 0.25, 95% CI 0.16-0.35, NNT 4) and mortality (RD -0.22, 95% CI -0.33-0.12, NNT 5). Compared with lactulose, hospital stay was also reduced in combination therapy, and there was no significant difference in treatment-related adverse events between the two groups. Combination of rifaximin and lactulose has beneficial effects on HE. Compared with lactulose alone, additional rifaximin increases clinical efficacy and decreases mortality. However, its effects on different types of HE are still uncertain.