Lucinda Harris, MD, MS, FACG1, Brooks D. Cash, MD, FACG2, Karim Moftah, PharmD3, Howard Franklin, MD3; 1Mayo School of Medicine, Scottsdale, AZ; 2University of Texas Health Science Center, Houston, TX; 3Bausch Health Companies, Inc., Bridgewater, NJ
Introduction: Treatment with probiotics such as Bifidobacterium lactis strains Bl-04, Bi-07, and HN019 and Lactobacillus strains L acidophilus (NCFM) and L paracasei (Lpc-37), administered alone or in multi-strain blends, has improved diarrhea, abdominal pain, bloating, and constipation symptoms in patients with gastrointestinal (GI) disturbances. A novel 5-strain (Bl-04, Bi-07, HN019, NCFM, and Lpc-37) probiotic blend has been developed for the symptomatic treatment of functional GI disturbances. Methods: Patients aged 18–75 years with symptoms of functional GI disturbances were eligible for inclusion in an open-label, multicenter study evaluating the safety and efficacy of the probiotic blend (NCT04155801). An oral capsule was administered once daily for 30 days. Patients were assessed at screening (Day −15 to −1), baseline (Day 1), Day 14, Day 30, and a follow-up visit (Day 42). The primary efficacy endpoint was patient-reported improvement in overall GI well-being at Day 30. Secondary efficacy endpoints included changes in GI symptoms assessed using the GI Health Symptom (11-point scale) questionnaire. The incidence of treatment-emergent adverse events (TEAEs) were recorded at all visits. Results: Of 188 study patients, 72.3% were female, with a mean (SD) age of 44.1 (13.4) years. At Day 30, 85.1% of patients achieved the primary endpoint, a positive response signifying improvement when asked about overall GI well-being. Improvements from baseline were reported at Day 30 in diarrhea frequency (47/62 patients [75.8%] with baseline frequency ≥3–4 days/week) and severity (69/79 patients [87.3%] with baseline severity ≥5) and constipation frequency (78/106 patients [73.6%] with baseline frequency ≥3–4 days/week) and severity (90/112 patients [80.4%] with baseline severity ≥5). Most patients reported improvement at Day 30 in bowel habit satisfaction (73.4%) and in straining severity (64.9%), urgency (65.4%), abdominal pain/discomfort (79.8%), bloating (77.7%), or distention (70.2%). All improvements reported at Day 30 were generally observable at Day 14. Total and drug-related TEAEs were reported in 18.6% and 8.0% of patients, respectively; the most common TEAEs were flatulence (3.2%) and cough (2.7%). No deaths, serious TEAEs, or discontinuations due to a TEAE occurred. Discussion: Treatment using a novel 5-strain probiotic blend improved GI symptoms in patients with functional GI disturbances with a favorable safety profile.
Disclosures: Lucinda Harris: Allergan – Grant/Research Support. Allergan – Consultant. Ironwood – Consultant. Takeda – Consultant. Brooks Cash: Salix Pharmaceuticals – Other Financial or Material Support, Personal Fees. Karim Moftah indicated no relevant financial relationships. Howard Franklin: Salix Pharmaceuticals – Employee.