Efficacy and safety of APT036 versus simethicone in the treatment of functional bloating: a multicentre, randomised, double-blind, parallel group, clinical study

Abstract

Background: Bloating is a common symptom reported by around 16% to 31% of the general population.Functional bloating is diagnosed in patients with recurrent symptoms of bloating who do not meet the diagnostic criteria of irritable bowel syndrome or other functional gastrointestinal disorders.Methods: This double-blind, multicentre, randomised study compared the safety and efficacy of APT036 (xyloglucan plus tyndallized Lactobacillus reuteri and Bifidobacterium brevis; Aprotecol ® ) and simethicone in treating functional bloating in adults. APT036 or simethicone were administered orally (3 times/day) for 20 consecutive days, with evaluations at baseline, and on Days 2, 10, 20 (end of treatment) and 30 (follow-up visit). The main outcome measure was safety. Efficacy was assessed at each visit by patient-reported symptom severity (Likert scale) and abdominal girth measurement. A hydrogen breath test was performed at baseline and Day 20.Results: Both APT036 (n=54) and simethicone (n=54) were well tolerated by study subjects; no adverse effects were reported with either treatment. Compared with simethicone, APT036 significantly reduced abdominal distension (P=0.008) and flatulence (P=0.010) from baseline to Day 30. The baseline hydrogen breath test confirmed the presence of small intestinal bacterial overgrowth (SIBO) in all subjects. At Day 20, mean hydrogen gas elevation was below the threshold for a diagnosis of SIBO (<12 ppm above basal on glucose administration) in both study arms.Conclusions: Both APT036 and simethicone had good safety profiles but APT036 was superior to simethicone in relieving symptoms of functional bloating.

Constipation and the Quality of Life in Conservatively Treated Chronic Kidney Disease Patients: A Cross-sectional Study

“…flatulence (lactulose). As the majority of CKD patients in our study reported bloating, anti-foaming agents—simethicone and dimethicone—should be taken into account because they are effective in relieving abdominal distension and flatulence in functional gastrointestinal disorders 45 , 46 . Moreover, alleviation of abdominal bloating in constipated patients is achievable using new laxative drugs: lubiprostone (a type-2 chloride channel activator), linaclotide (a guanylate cyclase-C receptor agonist), prucalopride (selective 5-HT4 receptor agonist), and elobixibat (an ileal bile acid transporter inhibitor) 47 - 50 .…”

Health Benefits of Heat-Killed (Tyndallized) Probiotics: An Overview

“…In a recent double-blind, multicenter, randomized clinical trial in adult subjects with a diagnosis of functional bloating, the administration of a medical device containing the mucosal protector xyloglucan plus tyndallized L. reuteri and B. breve , during 20 consecutive days, produced higher symptoms relief than simethicone, particularly regarding abdominal distension and flatulence. Of note, at baseline, all subjects had a diagnosis of small intestinal bacterial overgrowth (SIBO) confirmed by the hydrogen breath test, while at the end of treatment a reduction in hydrogen gas production was observed in both treatment arms [31].…”

“…Favorable properties of heat-killed bacteria have been observed in in vitro, animal models [27], and clinical trials [30,31], which have demonstrated their benefits in different indications, for example in neonates, without incurring the risks associated with live microorganisms [14,32], and with pharmaceutical advantages in terms of transport and storage (Table 1).…”

Impact of Heat-Killed Lactobacillus casei Strain IMAU60214 on the Immune Function of Macrophages in Malnourished Children

“…In experimental animal models [ 20 ] and in human clinical trials [ 21 , 22 ], positive effects of heat-killed bacteria in different conditions have been observed, such as probiotic administration in neonates, without the risks associated with live bacteria [ 23 , 24 ]. Preparations with dead or live microorganisms and metabolites have shown good biological properties in terms of reestablishing intestinal homeostasis; in many cases, these effects are similar to those obtained with the administration of live bacteria [ 20 , 25 ].…”