Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial.

Background: Increasing buprenorphine/naloxone (B/N) access for opioid use disorder (OUD) is essential yet ensuring adherence and preventing diversion remains challenging. This study examines the feasibility, usability, and acceptability of MySafeRx, a mobile platform integrating motivational coaching, adherence monitoring, and electronic dispensing during office-based B/N treatment. Methods: In this multi-site randomized controlled trial, MySafeRx provided coaching and supervised self-administration of B/N by mobile recovery coaches (MRCs) via videoconference. Referred adults (ages 18-65) with OUD were randomized to 1) 42-days of adjunctive MySafeRx treatment (n = 13) or 2) a standard care control group (n = 14). Results: The randomized sample was 63% female and 100% White. Twelve of 13 MySafeRx participants completed at least one MRC session. The mean system usability score reported by MySafeRx participants was 78.4 (n = 12). Participants indicated they would recommend MySafeRx to a friend (mean= 4.1 of 5), and that the dispenser (4.1 of 5) and videoconferencing (4.2 of 5) were easy to use. The MRC component had the highest acceptability (4.4 of 5). MRCs observed B/N self-administration for an average of 64.3% of the required study days (men: 68.9%; women: 57.9%). On average, men (n = 4) met with MRCs on 32±14 days versus 47±6 days for women (n = 8). Exploratory analyses did not show significant differences between intervention and control groups. Conclusions: Despite the small sample, this study supports usability and acceptability of MySafeRx. Increased adherence monitoring, even with remote coaching had limited appeal, which impacted feasibility due to slow recruitment, especially as community prescribing with relaxed monitoring requirements became more widespread.

Antibacterial and anti-inflammatory effects of Lactobacillus reuteri in its biofilm state contribute to its beneficial effects in a rat model of experimental necrotizing enterocolitis.

INTRODUCTION: Necrotizing enterocolitis (NEC) remains a significant surgical emergency in neonates. We have demonstrated the efficacy of Lactobacillus reuteri (Lr) in protecting against experimental NEC when administered as a biofilm by incubation with maltose loaded dextranomer microspheres. Lr possesses antimicrobial and anti-inflammatory properties. We developed mutant strains of Lr to examine the importance of its antimicrobial and anti-inflammatory properties in protecting the intestines from NEC. METHODS: Premature rat pups were exposed to hypoxia/hypothermia/hypertonic feeds to induce NEC. To examine the importance of antimicrobial reuterin and anti-inflammatory histamine, pups received either native or mutant forms of Lr, in either its planktonic or biofilm states, prior to induction of NEC. Intestinal histology was examined upon sacrifice. RESULTS: Compared to no treatment, administration of a single dose of Lr in its biofilm state significantly decreased the incidence of NEC (67% vs. 18%, p < 0.0001), whereas Lr in its planktonic state had no significant effect. Administration of reuterin-deficient or histamine-deficient forms of Lr, in either planktonic or biofilm states, resulted in significant loss of efficacy. CONCLUSION: Antimicrobial and anti-inflammatory effects of Lr contribute to its beneficial effects against NEC. This suggests that both infectious and inflammatory components contribute to the etiology of NEC.

A novel probiotic therapeutic in a murine model of Clostridioides difficile colitis.

For prophylactic therapy, mice received an oral antibiotic cocktail followed by clindamycin injection, followed by probiotic administration (planktonic vs. biofilm state), followed by C. difficile oral gavage. For treatment therapy, mice received antibiotics and C. difficile first, followed by probiotic administration. Clinical sickness scores (CSS) and intestinal histologic injury scores (HIS) were assigned.In the Prophylactic Therapy model, CSS: 67% of untreated mice exposed to C. difficile demonstrated CSS ≥ 6, which is consistent with C. difficile infection (p< .001 compared to unexposed mice). In mice treated with planktonic Lr, 55% had a CSS ≥ 6, but only 19% of mice treated with Lr in its biofilm state had CSS ≥ 6 (p< .001). Mice receiving Lr + DM-Maltose lost the least amount of weight compared to mice receiving saline (p = .004676) or to mice receiving Lr (p= .003185). HIS: 77% of untreated mice exposed to C. difficile had HIS scores ≥4, which is consistent with C. difficile infection. In mice treated with planktonic Lr, 62% had HIS ≥4, but only 19% of mice treated with Lr in its biofilm state had HIS ≥4. (p< .001). Additionally, mice treated with Lr in its biofilm state had better survival compared to untreated mice and to mice treated with planktonic Lr (p ≤ 0.05). Similar findings for weight loss, CSS, HIS and survival were obtained for Treatment Therapy.A single dose of Lactobacillus reuteri in its biofilm state reduces the severity and incidence of experimental C. difficile infection when administered as both prophylactic and treatment therapy.