Observation of Faecal Microbiota Transplantation Use for Restoration of Gut Microbiota in Gastrointestinal Disorders in the Real-World Setting (The REAL-BIOME (Real-world Microbiome) Study).A Phase IV, Real-World, Prospective, Open-Label, Observational Study.

开始日期2024-11-04

申办/合作机构

Biomebank初创企业

NCT06618326 / Not yet recruitingN/AIIT

ACUPUNCTURE VERSUS BIOFEEDBACK TRAINING on BOWEL MOTILITY in CHILDREN with FUNCTIONAL CONSTIPATION

: Functional constipation is the most common gastrointestinal disorder affecting about 14 % of the global population and it negatively impacts the quality of life of those affected (Suares and Ford,2011). In addition, there is a substantial cost to health care systems and further out of pocket costs are incurred by those suffering from the condition. In the UK, costs of £168 million to the National Health Service have been reported by the Bowel Interest Group for just 1 year (2018-2019), with more than 175 000 patient days spent in hospital and numbers are increasing (Bowel Interest Group, 2020).
Traditional Chinese medicine believes that constipation is mostly caused by improper diet, emotional disorders, old age and physical weakness, and feelings of external evil; the disease is mainly in the intestine and is related to the spleen, stomach, lung, liver, kidney, and other visceral dysfunctions; the basic pathogenesis is the conduction dysfunction of the large intestine. Acupuncture and moxibustion treatment of constipation should start from the diseased part and the associated viscera, and the treatment principle is to clear the organs and lead the stagnation. The most used acupuncture points for the treatment of constipation in modern acupuncture are Tianshu (526 times), followed by Shangjuxu (366 times), Dachangshu (334 times), Zusanli (328 times), and Zhigou (306 times). Among them, Tianshu acupoint is the most used acupoint and it has a large gap with the value of Shangjuxu in the second place. The values of the acupoints in the 2nd to the 5th place are more balanced, and the value of Qihai in the sixth place is different from Zhigou in the fifth place. Also, the difference between the 6th and 15th positions is more balanced. From the frequency of acupuncture treatment of constipation, the top 5 acupoints are Tianshu, Shangjuxu, Dachangshu, Zusanli, and Zhigou (Fengzhi et al., 2023).
Biofeedback Therapy The goal of neuromuscular training using biofeedback techniques is to restore a normal pattern of defecation. Neuromuscular training or biofeedback therapy is an instrument-based learning process that is based on "operant conditioning" techniques. The governing principal is that any behaviour-be it a complex manoeuvre such as eating or a simple task such as muscle contraction-when reinforced its likelihood of being repeated and perfected increases several fold. In patients with dyssynergic defecation, the goal of neuromuscular training is two-fold. (Rao, 2008).

开始日期2024-11-01

申办/合作机构

Cairo University

ITMCTR2024000513 / Recruiting

Study on the improvement of functional constipation with chicory and poria composite dietary fiber

开始日期2024-10-08

申办/合作机构

河南省疾病预防控制中心

100 项与功能性便秘相关的临床结果

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100 项与功能性便秘相关的转化医学

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0 项与功能性便秘相关的专利（医药）

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项与功能性便秘相关的文献（医药）

2024-12-01·Hospital Pharmacy

Evaluation of Polyethylene Glycol Dosing for Functional Constipation in Children

Article

作者: Morgan, Jill A ; Kruger Howard, Amy

Objective: The goal of this study was to evaluate the current use of polyethylene glycol (PEG) in a pediatric gastroenterology outpatient clinic. The primary endpoint was to determine the current weight-based PEG dosing schedules used for home cleanouts and maintenance treatment for functional constipation. The secondary endpoint was to assess the dosing efficacy for home cleanouts. Methods: This study was a retrospective cohort analysis of electronic medical records documenting new patient visits at our pediatric gastroenterology clinic between September 2017 and October 2018. Patients included in the study were 13 months to 18 years of age and prescribed PEG for an at-home cleanout and/or maintenance therapy for functional or slow transit constipation. Study participants given a clean-out regimen were divided into those who received treatment for less than 2 days or more. Cleanouts were considered successful if documented as such by the prescriber in the follow-up note or if there was documentation of clear flow. Results: Of the 201 new patients included, 112 (55.7%) received a recommendation for a home cleanout. Of these, 111 patients (99%) underwent PEG-based therapy with or without additional agents. The median weight-based PEG dose was 5.3 ± 2.4 and 4.6 ± 1.9 g/kg/day for 1- and 2-day cleanouts, respectively ( P = 0.124). Of the 38 patients with documented outcomes, 28 (73.7%) were successful. We observed no statistically significant differences in the number of successful versus unsuccessful outcomes based on PEG dosing ( P = 0.3) or cumulative dose exposures ( P = 0.388). Similarly, we observed no significant differences when comparing those on 1-day versus 2-or-more-day cleanouts, ( P = 0.17). The median weight-based maintenance PEG dose was 0.74 g/kg/day (interquartile range [IQR], 0.55, 0.96). Conclusions: While the PEG doses used by this clinic for 1-day bowel cleanouts align with the NASPGHAN best practices for colonoscopy report, patients who underwent a 2-day cleanout were provided more than double the weight-based doses. The doses were nearly 3-fold higher than the recommended doses for functional constipation home cleanouts. More information will be needed to determine if these higher doses for home cleanouts are needed for the successful management of patients with functional constipation.

2024-11-01·Neurogastroenterology & Motility

The effect of fiber supplementation with agave fructans or psyllium plantago in symptoms of constipation and its relation with whole and regional transit time and pH

Article

作者: Nosthas, Lorena Cassis ; Arenas‐Martínez, Josealberto Sebastiano ; Coss‐Adame, Enrique ; Bustillo‐Armendriz, Gustavo ; García‐Cedillo, María Fernanda

AbstractBackgroundSupplementation with the Agave tequilana Weber blue variety fructans is a feasible treatment option for functional constipation (FC). However, its effects on colonic function have not yet been studied. This study assessed whole gut transit time (WGTT) and regional transit time using a wireless motility capsule (WMC) before and after supplementation with different fiber treatments in patients with FC.MethodsA secondary analysis was performed on data collected from a randomized, double‐blind clinical trial comparing agave fructans with psyllium plantago. WGTT, regional transit time, contractility, and pH were measured using WMC before and after fiber supplementation. Comparisons were performed using nonparametric tests.Key ResultsTwenty patients with FC were evaluated, with a median age of 39 (25–54 years), and 18 (90%) were women. Five patients were included in each intervention group. There were no changes in WGTT or regional transit times between the groups (p > 0.05). Similarly, there were no differences in the changes experienced by regional or general contractility among the groups (p > 0.05). The cecal pH profile did not differ between the groups before and after fiber supplementation (p > 0.05). The percentages of clinical responses and consistency of bowel movements between the groups were similar.Conclusions & InferencesFC presents a clinical response to a fiber challenge, regardless of the administered intervention. However, this response was not associated with improvement in contractility or regional transit time. We speculate that there are other mechanisms by which fiber consumption may improve FC.

2024-10-22·Zhonghua yi xue za zhi

[Comparative analysis of the characteristics of high-resolution anorectal manometry in children with outlet obstructive constipation of different age groups].

Article

作者: Li, Q H ; Wang, R F ; Li, X Q ; Xue, F M

目的： 比较不同年龄段出口梗阻型便秘（OOC）患儿高分辨率肛管直肠测压（HR-ARM）特征。 方法： 回顾性纳入2019年1月至2023年9月在郑州大学附属儿童医院消化内科行HR-ARM检查的功能性便秘（FC）患儿的临床资料，根据年龄分为低年龄组（4岁≤年龄<6岁）和高年龄组（6岁≤年龄≤15岁），根据HR-ARM结果分为OOC组（存在盆底肌肉收缩不协调、排便时直肠推动力不足或收缩肛管括约肌松弛不足者）和非OOC组。分别比较2个年龄段OOC组和非OOC组患儿间的直肠动力学［直肠静息压、最大缩榨压（MSP）、力排时直肠压力、肛管残余压、直肠肛管压力梯度］、直肠感觉功能（直肠初始感觉容量阈值、初始便意容量阈值、排便窘迫容量阈值、最大耐受容量阈值）等指标。 结果： 共纳入228例FC患儿，男146例，女82例，年龄［M（Q₁，Q₃）］为7.5（6.0，9.7）岁，其中低年龄组54例，高年龄组174例；OOC组131例，非OOC组97例。低年龄组中OOC患儿（30例）的直肠静息压、肛管括约肌静息压、MSP、力排时直肠压力和直肠初始感觉容量阈值、初始便意容量阈值、排便窘迫容量阈值、最大耐受容量阈值和非OOC患儿（24例）相比差异均无统计学意义（均P>0.05）。高年龄组OOC患儿（101例）的肛管残余压高于非OOC患儿（73例）［102（70，113）比41（24，58）mmHg（1 mmHg=0.133 kPa），P<0.001］，直肠肛管压力梯度低于非OOC患儿［-43（-55，-23）比16（9，29）mmHg，P<0.001］，初始便意容量阈值高于非OOC患儿［90（54，110）比60（50，91）ml，P=0.024］。 结论： 与同年龄段非OOC患儿相比，6岁及以上OOC患儿的肛管残余压和初始便意容量阈值较高，直肠肛管压力梯度较低；6岁以下OOC患儿的各直肠感觉功能差异均无统计学意义。.

项与功能性便秘相关的新闻（医药）

2024-10-24

·BioSpace

Ironwood Pharmaceuticals to Host Third Quarter 2024 Investor Update Call

BOSTON--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD) today announced it will host its third quarter 2024 investor update conference call and webcast at 8:30 a.m. Eastern Time on Thursday, November 7, 2024. Individuals interested in participating in the call should dial (888) 596-4144 (U.S. and Canada) or (646) 968-2525 (international) using conference ID number and event passcode 2530602. To access the webcast, please visit the Investors section of Ironwood’s website at . The call will be available for replay via telephone starting Thursday, November 7, 2024 at approximately 11:30 a.m. Eastern Time, running through 11:59 p.m. Eastern Time on Thursday, November 21, 2024. To listen to the replay, dial (800) 770-2030 (U.S. and Canada) or (609) 800-9909 (international) using conference ID number 2530602. The archived webcast will be available on Ironwood’s website for 1 year beginning approximately one hour after the call has completed. About Ironwood Pharmaceuticals Ironwood Pharmaceuticals (Nasdaq: IRWD), an S&P SmallCap 600® company, is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). LINZESS is also approved for the treatment of functional constipation in pediatric patients ages 6-17 years-old. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure (SBS-IF), as well as several earlier stage assets. Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs. Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, with a site in Basel, Switzerland. We routinely post information that may be important to investors on our website at . In addition, follow us on Twitter and on LinkedIn . Contacts Investors: Greg Martini, 617-374-5230 gmartini@ironwoodpharma.com Matt Roache, 617-621-8395 mroache@ironwoodpharma.com Media: Beth Calitri, 978-417-2031 bcalitri@ironwoodpharma.com

上市批准

2024-10-12

·药智网

9月一致性评价月报：193个品种过评，涉及192家企业

药智数据显示，9月有193个品种通过/视同通过一致性评价，涉及192家企业（以集团企业进行统计），其中42家企业为多品种过评。过评 1、一致性过评整体情况较8月通过/视同通过的一致性评价品种数，9月共增长了47个品种。以新注册分类仿制药上市的品种共161个，以仿制药一致性评价补充申请过评的品种数整体呈下降趋势，9月共39个。以已上市药品批文统计（批文批准日期截至2024.09.26），9月有16个品种以新注册分类仿制药上市，首家视同通过一致性评价，还有3个品种首家以一致性评价补充申请过评，在此前已有企业视同通过一致性评价（详见文末表1）。图1 2024年2月-2024年9月一致性过评趋势注：以药品名称除重后统计过评品种数 2、企业过评品种数从企业过评品种数而言，9月共有193个品种通过/视同通过一致性评价，涉及192家集团企业，其中42家企业为多品种过评。上海复星医药（集团）股份有限公司过评品种数最多，共6个品种；其次成都倍特、广州白云山等7个集团企业各有4个品种通过/视同通过一致性评价。图2 2024年9月企业过评品种数注：以药品名称+持有人对应的集团企业进行除重后统计上海复星医药（集团）股份有限公司目前共有122个品种通过/视同通过一致性评价，其中59个品种以一致性评价补充申请过评，还有63个品种以新注册分类仿制药上市、视同通过一致性评价。9月，上海复星医药（集团）股份有限公司有2个品种以一致性评价补充申请过评，分别为注射用头孢呋辛钠、注射用头孢唑林钠；4个品种以新注册分类仿制药视同通过一致性评价，分别为利培酮口崩片、奥沙利铂注射液、普伐他汀钠片、马来酸氟伏沙明片。成都倍特药业股份有限公司目前共有116个品种通过/视同通过一致性评价，其中43个品种以一致性评价补充申请过评，还有73个品种以新注册分类仿制药上市，视同通过一致性评价。9月，成都倍特药业股份有限公司的甲磺酸仑伐替尼胶囊和钆特醇注射液以新注册分类仿制药视同通过一致性评价，乳酸环丙沙星氯化钠注射液和氯化钾注射液以仿制药一致性评价通过一致性评价。 3、品种过评企业数从品种过评企业数而言，9月有49个品种为多企业过评，以复方聚乙二醇电解质散(Ⅲ)过评企业数最多，吲哚布芬片、盐酸丙卡特罗口服溶液、铝碳酸镁咀嚼片各有4家企业过评，还有玻璃酸钠滴眼液等10个品种各有3家企业过评。图3 2024年9月品种过评企业数注：以药品名称+持有人对应的集团企业进行除重后统计复方聚乙二醇电解质散(Ⅲ)用于治疗功能性便秘。2023年10月重庆华森制药首家视同通过一致性评价后，目前共有14家企业视同通过一致性评价，其中9月新添5家企业过评，分别为扬子江药业集团有限公司、北京诚济制药股份有限公司、青岛力腾医药科技有限公司、成都医路康医学技术服务有限公司、重庆迈川医药科技有限公司。铝碳酸镁咀嚼片用于非溃疡性消化不良、胆汁反流性胃炎等疾病。2019年3月华润三九医药股份有限公司首家视同通过一致性评价后，目前已有30家企业通过/视同通过一致性评价，其中9月新增4家企业，分别为哈尔滨华瑞生化药业有限责任公司、河南比福制药股份有限公司、北京天衡药物研究院有限公司、济南高华制药有限公司。 4、集采情况 9月过评的品种中，100个品种已纳入集采，占38.17%，其中系统用抗感染药最多，共有20个品种；非集中采购品种中，消化道及代谢用药最多，有33个品种。图4 2024年9月过评品种的集采情况备注：以药品名称+持有人对应的集团企业进行除重后统计图5 2024年9月纳入集采品种ATC分类情况注：以药品名称+持有人对应的集团企业进行除重后统计图6 2024年9月未纳入集采品种ATC分类情况注：以药品名称+持有人对应的集团企业进行除重后统计 5、参比制剂情况在参比制剂方面，9月已过评的193个品种中，仅甘露醇注射液暂无NMPA公布的参比制剂正式通稿信息，石家庄四药有限公司继湖南科伦制药有限公司之后，成为第二家视同通过一致性评价的企业。申报 1、一致性申报整体情况在一致性评价补充申请品种数量方面，从2024年2月，申请品种数逐月减少，7月有短暂回升后再次下降，9月有29个品种申报。在新注册分类仿制药上市方面，9月申报品种数明显高于2024年申报平均品种数（233个品种）。图7 2024年2月至2024年9月申报详情注：数据按药品名称除重后进行统计 2、一致性评价补充申请ATC分类从申报一致性评价补充申请药品的ATC分类而言，9月消化道及代谢成为申报类型最多的领域，共11个品种，其次是系统用抗感染药和神经系统用药，各有5个品种申报。图8 2024年9月申报一致性评价品种ATC分类注：榜单数据按通过一致性评价品种ATC分类1级分类进行统计 3、一致性评价补充申请参比制剂情况 9月，申报一致性评价补充申请的品种均有参比制剂正式通稿信息。表1 2024年9月首家通过一致性评价详情表数据来源：药智数据企业版——仿制药一致性评价分析系统声明：本内容仅用作医药行业信息传播，为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 史蒂文转载开白 | 马老师 18996384680（同微信）商务合作 | 王存星 19922864877（同微信）阅读原文，是受欢迎的文章哦

一致性评价

2024-09-02

·医药地理

【儿药月度活动】传承精华守正创新，共话儿童用中成药高质量发展

2024年8月28日，由中国儿童药物研发与产业化生态圈联合中国儿科人群临床试验协作网共同主办，国家儿童医学中心首都医科大学附属北京儿童医院与中国医药工业信息中心共同承办的“儿童用中成药创新发展研讨会”成功举办。会议邀请了政产学研医媒体等多方代表，吸引了上万人次产业同仁直播参会。中医药作为中华民族的瑰宝，历经数千年而不衰，它独特的理论体系和治疗方法，在现代医学快速发展的今天，依然焕发着勃勃生机。特别在儿童健康领域，许多历史悠久的中药制剂因其显著的临床疗效，护佑着孩子们的成长。本次研讨会携手多位中医药领域专家，共话中成药的传承与创新，共谋儿童用中成药的美好未来。以传世名药王氏保赤丸为例，介绍了它的非凡历程，从诞生到创新发展，每一步都凝聚着中医中药人的智慧和汗水。在传承和荣耀背后，是不断的探索，从创新到药理学的研究，从循证医学研究到国际化的探索，始终走在了中药发展的前沿，既保留了传统中药的精髓，又在现代科学的指引下焕发着新的光芒。中医药学这一源远流长博大精深的文化瑰宝，历尽沧桑而愈显其独特的魅力。中成药如何精准定位西医病种，在临床中如何合理且准确的使用中成药，这是一个很大的课题。能达到精准的使用中成药来治疗儿科疾病，相关循证医学的研究之路还很长。精准治疗包括三个方面：第一是精准定位；第二是精准评价；第三是精准研发。除此之外，儿童中成药如何与其他药物配伍使用也是今后需要研究与探讨的重要课题。当前我国中成药市场稳步增长，发展动力强劲，尤其儿童中成药备受关注，在临床治疗儿童疾病中占据重要地位。中成药精准定位西医病种及循证医学研究，有助于临床大夫更好地使用药物。中成药对肠道菌群稳态的调控与毒理学作用研究，为中成药在世界范围内的临床应用提供了可能。中成药的生命力在于临床疗效，既需要通过询证方法展现它的疗效和安全性，也需要通过基础研究方法增强中药自信和他信力。功能性胃肠病是与年龄相关的慢性反复发作的胃肠道功能异常，包括婴儿反流综合征、周期性呕吐、婴儿肠绞痛、功能性腹泻和功能性便秘等七个病种。我国婴儿功能性消化不良综合征的患病率为38%，经过随机双盲安慰剂对照的多中心临床研究，验证王氏保赤丸治疗应用功能消化不良综合征的疗效是确切的，能有效消除和缓解消化不良等相应症状，是一个疗效突出又安全的药物。中药的发展历史悠久。王氏保赤丸的临床应用超过100年，安全性得到临床验证，可适用于不同年龄段的患者。虽然中药成分复杂，研究难度较大，但生物学活性可能不弱于单一成分的西药，且疗效优异，适应症广泛，如王氏保赤丸能双向调节肠道蠕动，同时治疗腹泻和便秘。中药的治疗方案与西药不同，能针对患者而非特定病症，提高人体生命力，这也是中药优于西药的优势。很多中药还维持传统的剂型和给药方式，基于这一点，在中药领域针对给药方式和给药途径的创新较多，希望在中药制剂研究中，针对临床需求开发更多更适合临床使用的中药。在传承临床有效的儿童药时，还要注意对传统工艺进行合理改造，以便更好的通过质量控制来发挥药效，进一步提升传统中药的有效性和安全性。研究儿童药，特别是儿童专用中成药的难度较大：能够完成儿童药的临床研究，特别是儿童专用中成药的研究单位数量不足；一些临床合并症也缺乏临床技术指导原则；临床方案的制定过程也充满挑战。对此，希望药监局和药审中心从政策方面更好的推动相关工作，鼓励和支持儿童药企业和儿科专家更好的开展新药研发。数据技术和人工智能的发展给人们生活和用药带来不同的变化，中医对自然和人体的认识也需要适应新的变化。患者对用药提出更快捷、更方便、更高效的需求，促进了以传统汤药为主的治疗过程向新的制剂、新的临床治疗方法转变，这种创新包括组方创新、剂型创新、口感创新、给药方式创新、老药新用以及研究方法的创新。目前儿童外用制剂较少，在儿童外用药研究中发现，儿童依从性较差，可以尝试儿童经鼻吸入给药或经皮渗透给药。对于已有药物来说改为外用制剂后可以扩大应用范围和适应症。医院儿科住院体量虽小，但使用的实验技术如清洗、敷贴等方法，为治疗提供了另一条途径和渠道，希望临床医生可以为企业在外用制剂开发中贡献方法和技术。王氏保赤丸是经典的儿童用药，在消化和呼吸系统上有广泛的临床应用，服用方便，儿童用药剂量也小。但其也存在不足之处，如适应症宽泛，医生用药有时不能明确定位，质量控制也不够严谨。在传承过程中针对这些不足，通过工艺标准化和质量控制方法如指纹图谱，保留传统工艺并提升质量标准。未来计划进行更多临床机制研究，以提升儿童中成药的品质，更好地服务于临床。从企业角度来看，儿童药的研发，最难的还是临床阶段。今年上市的两个品种在二期临床试验中遇到各种问题，得到了各方专家的指导。另外，还存在一些难点，如剂量探索研究，或者开展临床试验时可备选机构数量不足等。希望行业专家可以联合药监部门，出台相应政策或指导原则，便于企业新药研发项目的推进。葫芦娃专注于儿童医药开发，尤其是儿科中成药领域。企业在选择一类新药开发时，会从中药的22个优势病种中选择对应的处方，在选择新药时，关注药材的多元性、可及性和毒性，对于儿童用药要特别注意避免选择含毒性的药材。对于二类中药，企业主要关注适应症的改变和儿童用药剂型的增加，也在探索通过真实世界研究来改善儿童用药的口感。我国儿童用药市场不成熟，品种少，剂量模糊，规格缺乏，主要集中在抗生素、感冒、解热镇痛、清热等常见病用药。2023年以来，国家发布了十项鼓励儿童用药的研发政策，但在中成药方面，过去十年儿童中成药获批上市及获批临床的药品数量很少。对此，人民日报健康客户端开设了儿童健康频道，重点关注儿童创新药和中成药，发布了约200篇关于儿童用药的报道，旨在呼吁解决儿童用药短缺问题。感谢精华制药集团股份有限公司对本次活动的大力支持！会议预告 2024年（第41届）全国医药工业信息年会将于9月6日-9日在成都召开，届时儿童药物创新发展大会将在9月8日同期举办，期待在成都与各位相聚！ END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001