6 • Sep–Dec 2023 • Vol LXII • No. 5 In Focus Florasante™ in the Management of Diarrhea-Dominant Irritable Bowel Syndrome An excerpt of a clinical study conducted by Ganesh S (to be published) is featured here. Aim To assess the efficacy and safety of Florasante capsule (a synbiotic capsule) in the management of diarrhea-dominant irritable bowel syndrome (IBS-D) in comparison with a standard comparator and placebo. Materials and Methods This randomized, placebo-controlled comparative study included 60 patients of both sexes (aged 18–65 y). Inclusion criteria were positive diagnoses of IBS-D (defined by the Rome III Criteria) along with an abdominal pain score of ≥ 3.0 on a 10-point scale (where 0, no change; 1, mild; 2, moderate; and 3, severe) and/or passing at least one stool with a consistency of type 6 or type 7 as per the Bristol Stool Chart on at least 2 days per week; willing to sign the informed consent and follow the study procedures; and not participated in a similar kind of study in the last 4 weeks. Patients on nonsteroidal anti-inflammatory drugs, corticosteroids, and topical or systemic antibiotics during the past 1 month; who had undergone major abdominal surgeries; who had a history of inflammatory bowel disease or diverticular disease, celiac disease, and allergic diseases; and women who were pregnant, breastfeeding, or had any underlying gynecologic disorder were excluded from this study. Patients were randomized into 3 groups (20 in each): group A received placebo, group B received Florasante, and group C received a standard comparator capsule (each capsule containing Bifidobacterium longum, Fructooligosaccharides, Lactobacillus acidophilus, Lactobacillus rhamnosus, and Saccharomyces boulardii as active ingredients). Each group received the designated medication at a dosage of 1 capsule, orally, BID, for 4 weeks. All patients were assessed for improvement in the quality of life (QoL). Data on clinical parameters (ie, abdominal pain and bloat- ing and stool frequency and consistency) and laboratory parameters were collected at baseline and at the end of weeks 2 and 4. Results The study findings showed that there was a significant improvement in all the clinical parameters evaluated in patients who received Florasante capsules compared with that in the patients who received the placebo and standard comparator capsules. Patients in group B showed a statistically significant reduction in the mean value of abdominal pain (P < .0061) at the end of week 2, and it remained statistically significant at the same values at the end of week 4. Similarly, abdominal bloating was significantly reduced at the end of week 2, and it was completely normalized at the end of week 4 (P < .0002) (Figure). Figure. Effect of Placebo, Florasante, and Standard Comparator Capsules on Abdominal Bloating a, compared with baseline; q, compared with placebo; r, compared with the standard comparator. VAS, visual analog scale. In group B, there was a statistically significant reduction in the mean score of stool frequency at week 4 (P < .0001). Furthermore, there was a statistically significant improvement in the mean score of stool consistency (P < .0027) at the end of week 4. All laboratory and hematologic parameters were within the normal limit, and there were no adverse events reported during the study period. All the patients in group B showed a significant improvement in QoL and overall health in terms of bowel health—improved energy level with reduced levels of fatigue, improved level of gastric emptying, and relishing food better. Conclusion The findings suggest that Florasante capsule is potentially safe and effective in the management of IBS-D, with improved QoL, thus facilitating overall bowel health. * a:P < .002 q:P < .0018 r:P < .0003 #a:P < .0002 q:P < .0007 r:P < .0001 @a:P < .0273 $ a:P < .0273 Baseline −1 −0.5 0 0.5 1 1.5 2 2.5 VAS Week 2 Week 4 Group B Group C Group A # * @ $
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