Safety And Efficacy Of A New Smartphone-controlled Vibrating Capsule On Defecation In Beagles And Clinical Patients

Constipation,mainly manifesting as abdominal discomfort and painful defecation,is considered as a chronic disorder.Due to a lack of effective therapy,it imposes a significant economic burden and greatly impact patients' quality of life which prompts searches for new,original approaches.Based on the research of vibrating capsule(VC)carried out by Ron et al.,we investigated the safety and efficacy of an innovative,multi-mode VC in terms of its effect on defecation.In animal studies.The parameters associated with different operation modes of VCs can be detected and adjusted by smartphone controlled external configuration device(ECD)externally.The results of blood tests,physiological parameters,CT scan and pathological examination showed no significant abnormality,which undoubtedly confirmed the safety of VCs.For efficacy studies,defecation frequency of beagles increased after administration of these capsules without influence on stool characters.Meanwhile,the mean time of capsule evacuation tended to be reduced while showing no significant difference between different modes.In summary,this study elucidates the safety and effectiveness in prompting the passage of gastrointestinal walls thus greatly increasing the defecation frequency.This study innovatively displays the promising application for the treatment of constipation.In clinical studies.we designed a double-blind,placebo-controlled study including 45 patients to evaluate the safety and efficacy of VC that in relieving constipation and gastrointestinal transmission.It is preliminarily confirmed that the VC is safe and can improve the quality of life of the patients.This research is carrying on at present.