Efficacy and Safety of eLAX TM Probiotic-Botanical Supplement in Improving Constipation: A Single-Center, Single-Arm Study

Background: Functional constipation impairs gut health and quality of life. Okra (Abelmoschus esculentus), traditionally used for treating gastrointestinal complaints, is rich in soluble dietary fiber and mucilaginous polysaccharides thought to increase stool water retention, soften feces, and promote luminal bulk, thereby facilitating colonic transit. Preclinical studies link okra mucilage to gut barrier support and favorable shifts in gut microbiota composition. The eLAX TM Probiotic-Botanical Supplement (eLAX) combines okra extract with Lactobacillus casei probiotics. We evaluated its efficacy and safety in a single-center, open-label, self-controlled study and report the complete 12-week dataset. Methods: Fifty-one adults meeting Rome IV criteria for functional constipation were enrolled at Xiangya Hospital; 49 completed the study and were analyzed. Participants received descending doses of eLAX over 10 weeks with intervening washouts (Weeks 1-2: 4 tablets/day; Week 3 washout; Weeks 4-6: 3/day; Week 7 washout; Weeks 8-10: 2/day), then 2 weeks of observation without product. The primary endpoint was the responder rate (increase in spontaneous bowel movements [SBMs] per 24 h versus baseline) at Weeks 2, 6, 10, and 12. Exploratory endpoints included gut microbiota, PAC-SYM, PAC-QOL-12, bowel diaries (frequency, straining, Bristol Stool Scale [BSS], abdominal pain), and assisted-defecation use. Safety included laboratory tests and colonoscopy in a subset. Results: Responder rates (N=49) were 87.8%, 61.2%, 55.1%, and 42.9% at Weeks 2, 6, 10, and 12. Mean SBM frequency rose from 0.51/day at baseline to 1.88, 1.35, and 1.12/day at Weeks 2, 6, and 10 (all p <0.0001), remaining above baseline at Week 12 (0.82/day, p =0.0086). Mean time to first bowel movement was 5.88±4.12 h (61.2% within half a day). BSS shifted from types 1-2 toward types 3-7 after 10 weeks (mean +2 grades); 69.3% retained ideal types 3-4 at Week 12. Straining resolved by Week 10; incomplete evacuation and abdominal pain declined. PAC-SYM (0-30) fell from 15.96±3.33 to 1.00±1.98 at Week 10 (−93.73%, p <0.0001) and remained improved at Week 12 (−78.64%). PAC-QOL-12 improved by 88.76% at Week 10 ( p <0.0001). Microbiota diversity rose 9.65% ( p =0.0091) and the Bacteroidetes/Firmicutes ratio rose 162.57% ( p <0.0001) at Week 10. No product-related adverse events occurred; colonoscopy (n=10) showed no melanosis coli. Conclusion: Over 12 weeks, eLAX was associated with significant improvements in bowel frequency, stool consistency, symptoms, quality of life, and gut microbiota, with a favorable safety profile. Benefits were most durable in participants without baseline spontaneous defecation; milder cases may need longer low-dose maintenance after tapering.