Treatment of non-constipated irritable bowel syndrome with ebastine

A recent study demonstrated the superiority of ebastine over the placebo, suggesting its potential as an innovative treatment option for patients diagnosed with non-constipated irritable bowel syndrome (IBS). This study’s findings were published in the journal, Gut.

In this randomized, double-blind, placebo-controlled trial, 202 participants were randomly divided into two groups to receive either ebastine (n=101) or a placebo (n=101) for a duration of 12 weeks. The subjects were evaluated based on abdominal pain intensity (API) and global relief of symptoms (GRS). The subject was classified as a weekly responder for GRS if they reported total or noticeable relief, and as a responder for API if their weekly average pain score decreased by a minimum of 30% compared to baseline. The primary endpoints of the study were the proportion of participants who were weekly responders for a minimum of 6 weeks out of the 12-week treatment period, both for GRS and API ('GRS+API', composite endpoint), as well as for the GRS and API individually.

At the end of the study, ebastine treatment demonstrated a notable increase in the number of responders (12%, 12/92) for GRS+API when compared to the placebo group (4%, 4/87).

The study results indicate that ebastine is more effective than placebo, suggesting it could be a valuable novel treatment for individuals with non-constipated IBS.

Over-the-scope clip as the primary treatment option for peptic ulcer bleeding

According to a recent study, over-the-scope-clip (OTSC) demonstrated superior efficacy compared to through-the-scope-clip (TTSC) in achieving successful initial hemostasis and overall clinical success. This study’s results were published in journal, Endoscopy.

This international, multicenter, randomized controlled trial included consecutive patients suspected of upper gastrointestinal bleeding (UGIB). Patients presenting with gastroduodenal peptic ulcers categorized as Forrest Ia-IIb were randomly assigned to undergo either OTSC or TTSC treatment in a 1:1 ratio. A total of 251 patients were screened, out of which 112 patients were ultimately randomized to receive OTSC (n=61) or TTSC (n=51) treatment. The primary outcome measured was the rate of 30-day rebleeding subsequent to successful initial hemostasis. Secondary outcomes of the study included rates of successful initial hemostasis and overall clinical success, which was defined as the combination of successful initial hemostasis and the absence of 30-day rebleeding.

The 30-day rebleeding rates for patients treated with OTSC and TTSC were 1.6% (1/61) and 3.9% (2/51) respectively. The OTSC group achieved a successful initial hemostasis rate of 98.4% (60/61), while the TTSC group had a rate of 78.4% (40/51) (p=0.001). The OTSC group had an overall clinical success rate of 96.7% (59/61), whereas the TTSC group had a rate of 74.5% (38/51).

The above study demonstrated that following first-line endoscopic therapy for acute peptic ulcer bleeding, low rates of 30-day rebleeding were observed with both OTSC and TTSC. However, OTSC proved to be more effective than TTSC in achieving successful initial hemostasis and overall clinical success.

Comparison between the top-down and accelerated step-up treatments for recently diagnosed Crohn's disease patients

A recent study showed that the combination of infliximab and an immunomodulator in a top-down approach resulted in significantly improved outcomes after 1 year compared to the accelerated step-up treatment. Therefore, it is recommended that top-down treatment be the standard of care for individuals recently diagnosed with active Crohn's disease. This study’s findings were published in The Lancet. Gastroenterology & Hepatology.

The PROFILE (PRedicting Outcomes For Crohn's disease using a moLecular biomarker) trial was a multicenter, open-label study that enrolled adults who were newly diagnosed with active Crohn's disease. Participants underwent blood tests to determine their biomarker status and 386 patients were randomly assigned to receive either top-down (n=193) or accelerated step-up treatment (n=193). The randomization was stratified based on the biomarker subgroup (IBDhi or IBDlo), the extent of the disease (colonic or other), and the severity of endoscopic inflammation (mild, moderate, or severe). The primary endpoint of the trial was to achieve sustained remission without the need for steroids or surgery up to week 48.

No significant biomarker-treatment interaction effect was observed (absolute difference 1 percentage point, 95% CI -15 to 15; p=0·944). The top-down group showed a significantly higher rate of sustained steroid-free and surgery-free remission compared to the accelerated step-up group (79% versus 15%). Additionally, the top-down group experienced fewer adverse events (168 versus 315), serious adverse events (15 versus 42), complications requiring abdominal surgery (1 versus 10), and no difference in serious infections (3 versus 8) compared to the accelerated step-up group.

The above results demonstrated that infliximab combined with an immunomodulator in a top-down treatment led to markedly better results after one year in contrast to the accelerated step-up treatment. It is recommended that top-down therapy be considered the standard of care for those with newly diagnosed active Crohn's disease.

Efficacy of VOS in showing reduced risk of recurrent Clostridioides difficile infection

According to a recent study, VOS, an oral microbiota therapeutic, reduced the risk of recurrent Clostridioides difficile infection (rCDI) at week 8. This study was published in the journal, Clinical infectious diseases.

The ECOSPOR III trial was a phase 3, double-blind, placebo-controlled, randomized trial that included 182 adult participants with rCDI who were randomized to receive 4 capsules daily for 3 days of VOS or placebo following standard-of-care antibiotics. This post hoc analysis assessed the rate of rCDI through week 8, including Charlson comorbidity index (CCI) score category, baseline creatinine clearance, exposure to non-CDI-targeted antibiotics after dosing, number of CDI episodes, and acid-suppressing medication use at baseline.

At the end of 8 weeks, comorbidities were common with a mean overall baseline age-adjusted CCI score of 4.1. However, the VOS-treated participants had a lower relative risk of recurrence across all subgroups analyzed. Hence, it can be concluded that VOS may reduce the risk of rCDI regardless of baseline characteristics, concomitant medications, or comorbidities.