Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Transit and evacuation of intestinal gas
研究概览
简要总结
Study to asess the effects of Iberogast® (STW5) and Iberogast® N (STW5-II) in intestinal gas transit and abdominal symptoms of patients suffering from irritable bowel syndrome or functional dyspepsia.
详细描述
Every day great amounts of gas enter into the intestine from several sources, including air swallowed during meals and gas produced by colonic fermentation by intestinal bacteria.
Recent studies have shown that gastric nutrients delay emptying of gastric gas in healthy subjects, and this effect is exacerbated in patients with functional dyspepsia, leading to a lower tolerance to gastric gas and greater gas-related epigastric symptoms. Likewise, patients with lower functional gut disorders, like irritable bowel syndrome or functional bloating, have an altered transit and evacuation of intestinal gas that is associated to abdominal symptoms. In addition, bloating and abdominal distension are gas-related abdominal symptoms that are common to both upper and lower functional gut disorders, and referred by a majority of patients, as their most bothersome symptoms.
STW5 (Iberogast®) is a medicinal product composed by 9 herbal preparations that has been shown to promote changes in gastric tone, gastrointestinal motility, intestinal inflammation and visceral sensitivity.
Iberogast® is approved in Spain for treatment of gastrointestinal disorders like dyspepsia and gastritis, as well as for symptomatic relief of associated symptoms as epigastric pain, bloating, flatulence, gastrointestinal colics, nausea and epigastric burning sensation (extract from Summary of product characteristics, SmPC) ).
STW5-II (Iberogast N®) is an herbal medicinal preparation consisting of six herbal extracts (Iberis amara whole plant, caraway fruits, liquorice roots, peppermint leaves, lemon balm leaves, and chamomile flowers). It contains an extract combination of Iberis amara as an alcoholic fresh plant extract as well as plant extracts of caraway fruits, liquorice roots, peppermint leaves, lemon balm leaves, and chamomile flowers as alcoholic drug extracts. The preparation contains 31% ethanol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Experimental group: Study 1: STW5 20 drops TID; Study 2: STW5-II 20 drops TID Control group: Placebo 20 drops TID
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has read and signed the institutional review board-approved informed consent form before screening.
- •≥18 years old.
- •Confirmed irritable bowel syndrome (ibs) or functional dyspepsia (fd) diagnosis per rome iv criteria.
- •Has active symptoms of bloating.
- •Subject must be willing to comply with the protocol.
- •Female subjects who are capable of conceiving must use an acceptable form of contraception in order to participate in the study*. *women of childbearing potential must have a negative pregnancy test prior to randomization into the study and commitment to use at least one of these birth control methods: male or female condom with or without spermicide, cap, hormonal contraception, diaphragm or sponge with or without spermicide, intrauterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence during the study. based on ich, m3 (r2) 2009 a woman is considered of childbearing potential: fertile, following menarche and until becoming post-menopausal unless permanently sterile. permanent sterilization methods include tubal ligation, hysterectomy, bilateral oophorectomy.
排除标准
- •Presence of any organic gastrointestinal diseases.
- •Subjects with known hypersensitivity to Iberogast or one of the active substances or excipients.
- •One or more medical condition(s), including renal, hepatic, hematologic, endocrinological, neurologic, or immune disease that in the opinion of the Investigator would make the subject an inappropriate candidate for this study.
- •Subjects with impaired liver function tests
- •Malignant disease not in remission.
- •Presence of any active infectious disease.
- •Subjects not willing to stop medications that may interfere with gastrointestinal motility during 48 h previous to the gas infusion tests. These include: bulking agents, laxatives, linaclotide, prokinetics, antidiarrheal or opioids.
- •Known alcohol or drug abuse.
- •Female participants of childbearing potential with a positive pregnancy test, breast feeding, or female participants of childbearing potential without adequate contraception.
- •Subject judged by the investigator or study staff to be unable or unlikely to comply with daily protocol requirements, or study visits.
研究组 & 干预措施
Study 1: Experimental: Study 2: Experimental
Iberogast® (STW5) or Iberogast® N (STW5-II) 20 drops TID per 14 days
干预措施: Iberogast® and Iberogast® N (Drug)
Study 1: Comparator Study 2: Comparator
Placebo 20 drops TID per 14 days
干预措施: Iberogast® and Iberogast® N (Drug)
结局指标
主要结局
Transit and evacuation of intestinal gas
时间窗: Baseline to Day 14
Colonic gas filling and evacuation (patients with irritable bowel síndrome) and Gastric gas transit (patients with functional dispepsia). Primary outcome measures will be evaluated by an infusion machine (to perform gas infusion) and a barostat (to perform gas collection measurement).
次要结局
- Objective abdominal distension(Baseline to Day 14)
- Perception of abdominal symptoms(Baseline to Day 14)
- Adverse events(Baseline to Day 14)
研究者
Dr. Jordi Serra Pueyo
MD. PH D.
Hospital Vall d'Hebron