Is continuing dexlansoprazole (Dexilant) 60 mg daily for two months safe, and will Saccharomyces boulardii (Florastor) prevent Clostridioides difficile infection?

Two Months of Dexilant 60mg and Saccharomyces boulardii for C. diff Prevention

Two months of dexlansoprazole (Dexilant) 60 mg daily is generally safe based on FDA approval and clinical trial data extending to 12 months, though you should reassess the ongoing indication and consider dose reduction if appropriate; Saccharomyces boulardii (Florastor) has weak evidence for preventing primary C. difficile infection but may help prevent recurrence in specific populations already experiencing CDI. 1, 2

Safety of Extended Dexlansoprazole Use

Duration and Dosing Considerations

• Dexlansoprazole 60 mg once daily has been studied and found well tolerated in pooled clinical trials lasting up to 12 months, so two months falls well within the established safety window. 3

• The FDA label does not specify a maximum duration for dexlansoprazole therapy, and the drug has demonstrated a good safety profile in both short-term and medium-term use comparable to other PPIs. 4, 1

• However, all acid-suppressing agents including dexlansoprazole share the same class-wide safety concerns as traditional PPIs, including potential increased risk of C. difficile infection, enteric infections, and elevated serum gastrin levels during treatment. 4

Important Safety Signals

• Dexlansoprazole (like all potassium-competitive acid blockers and PPIs) is associated with C. difficile infection risk at a magnitude comparable to traditional PPIs, making the question about concurrent probiotic use particularly relevant. 4

• Serum gastrin levels rise with dexlansoprazole use and remain elevated throughout treatment, though levels return toward baseline within weeks after discontinuation; long-term clinical significance remains under investigation. 4

• No dose adjustment is needed for mild hepatic impairment (Child-Pugh A), but dose reduction is recommended for moderate impairment (Child-Pugh B), and dexlansoprazole is not recommended for severe hepatic impairment (Child-Pugh C). 1

Clinical Reassessment at Two Months

• At the two-month mark, you should critically evaluate whether ongoing PPI therapy remains indicated, as stewardship activities to discontinue unneeded PPIs are strongly warranted given the association between PPI use and CDI. 4

• If continued acid suppression is necessary, consider whether the 60 mg dose (approved for healing erosive esophagitis) can be stepped down to 30 mg (approved for maintenance of healed erosive esophagitis and symptomatic GERD) to minimize acid suppression and potentially reduce infection risk. 1, 3

Saccharomyces boulardii for C. difficile Prevention

Evidence for Primary Prevention

• The role of S. boulardii in primary prevention of CDI (preventing first infection in patients on antibiotics) is poorly defined, with available studies lacking statistical power to detect significant differences. 2

• Two trials examining primary prevention in populations recently prescribed antibiotics failed to demonstrate statistically significant benefit, though the studies were underpowered. 2

• The 2024 AGA guideline on fecal microbiota-based therapies does not recommend S. boulardii for primary CDI prevention, focusing instead on fecal microbiota transplantation for recurrent disease. 4

Evidence for Secondary Prevention (Recurrence)

• For patients already experiencing recurrent CDI, one trial showed a significant reduction in relapses (RR=0.53; P<0.05) when S. boulardii was added to antibiotic therapy. 2

• Another study demonstrated a trend toward reduction of CDI relapse in patients receiving high-dose vancomycin (RR=0.33; P=0.05), suggesting benefit may be specific to certain antibiotic regimens. 2

• The evidence suggests S. boulardii may be effective for secondary prevention in specific patient populations with particular concurrent antibiotic treatment, but its role in primary prevention remains unproven. 2

Safety Profile

• Patients taking S. boulardii experienced increased risk for thirst and constipation, but the probiotic appears generally well tolerated. 2

• No serious adverse events were reported in the systematic review of S. boulardii trials, supporting its safety profile for patients concerned about CDI risk. 2

Practical Clinical Algorithm

For Patients on Dexlansoprazole Without Active CDI

1. Continue dexlansoprazole 60 mg for the full two months if clinically indicated (e.g., healing erosive esophagitis), as this duration is well within established safety parameters. 1, 3

2. Do not routinely add S. boulardii for primary CDI prevention unless the patient has additional high-risk features (multiple antibiotics, prior CDI history, severe comorbidities). 2

3. At two months, reassess the indication: if healing is achieved, step down to dexlansoprazole 30 mg for maintenance or consider discontinuation if symptoms have resolved. 1, 3

For Patients With Prior CDI or High Recurrence Risk

1. If the patient has a history of recurrent CDI and requires ongoing antibiotics or PPI therapy, consider adding S. boulardii as adjunctive therapy based on the secondary prevention data. 2

2. Discontinue the PPI if possible, as continued acid suppression significantly increases CDI recurrence risk. 4

3. If PPI therapy cannot be stopped, use the lowest effective dose and maintain heightened vigilance for CDI symptoms (≥3 unformed stools in 24 hours). 4

Critical Pitfalls to Avoid

• Do not assume S. boulardii provides robust primary prevention against first-time CDI—the evidence does not support routine use in this setting. 2

• Do not continue dexlansoprazole 60 mg indefinitely without reassessing the indication—step down to 30 mg for maintenance therapy once healing is achieved. 1, 3

• Do not ignore the increased CDI risk associated with PPI use—if a patient develops new-onset diarrhea (≥3 unformed stools in 24 hours), test for C. difficile promptly. 4

• Do not use S. boulardii as a substitute for appropriate CDI treatment (vancomycin or fidaxomicin)—it is only an adjunct for prevention, not active therapy. 4, 2