ACTRN12622001140741招募中未知
Impact of manuka honey on symptoms and quality of life in patients with functional dyspepsia: a feasibility study
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Adults with mild/moderate functional dyspepsia (FD) and Body Mass Index between 18.5 and 35 kg/m2.
- •FD participants will be selected based on the ROME IV Diagnostic Criteria (fulfilled for the last three months with symptom onset at least six months prior to diagnosis):
- •1.Must include one or more of the following:
- •- Bothersome postprandial fullness
- •- Bothersome early satiation
- •- Bothersome epigastric pain severe enough to impact on usual activities
- •- Bothersome epigastric burning severe sufficient to impact on normal activities
- •2.No previous diagnosis of structural disease (including at upper endoscopy) that is likely to explain the symptoms
- •3.Must fulfil criteria for Postprandial Distress Syndrome (PDS) and/or Epigastric Pain Syndrome (EPS) as follows:
- •a.PDS: must include one or both of the following at least three days a week:
- •- Bothersome postprandial fullness severe enough to impact on usual activities
- •- Bothersome early satiation severe enough sufficient to prevent finishing a
- •regular size meal
- •b.EPS: must include one or both of the following at least one day a week:
- •- Bothersome epigastric pain severe enough to impact on usual activities
- •- Bothersome epigastric burning severe sufficient to impact on usual activities
- •People with mild to moderate severity of dyspepsia will be identified with the Short Form Leeds Dyspepsia Questionnaire. This consists of eight items that assess the presence and severity of dyspepsia by measuring the frequency and severity of upper abdominal pain/discomfort, heartburn, regurgitation and nausea. Possible scores range from 0 to 32 with higher values corresponding with increasing severity of dyspepsia. A score of 1 to 23 indicates mild to moderate dyspepsia symptoms.
排除标准
- •- Inability to give informed consent
- •- Severe functional dyspepsia, defined by a score of 23 or higher from the Short Form Leeds Dyspepsia Questionnaire
- •- Taken antibiotics within the month before starting the study
- •- Use of certain prescribed medication or recreational drugs. People taking Proton Pump Inhibitors, H2-receptor antagonists, antacids, mucosal protectants, prokinetics, antidepressant drugs if they were prescribed solely for controlling dyspepsia symptoms, anticholinergic agents, cholinergic agents, and over-the-counter herbal remedies used to treat dyspepsia symptoms will be required to stop taking four weeks prior to the start of the study
- •- Helicobacter pylori-positive (physician-diagnosed) or undertaking treatment for H. pylori infection within one month of initiation of study. Potential participants will also be screened for H. pylori infection prior to beginning the lead-in and intervention.
- •- Alarm features associated with significant GI or other disorders, such as abdominal pain that wakes the patient from sleep; frequent vomiting; family history of gastrointestinal (GI) malignancies suggestive of a significant hereditary cancer syndrome; lower GI bleeding; odynophagia; dysphagia.
- •- Medical history of upper GI surgery or other significant disorders (inflammatory bowel disease, ulcerative colitis, coeliac disease, Crohn's disease), significant cardiorespiratory disease, diabetes mellitus, significant bleeding disorders, sleep disorders, active psychiatric conditions (major depressive disorder, schizophrenia)
- •- Significant weight loss (>5% of total body weight) during the six months before starting the study
- •- Significant dietary changes within the month before starting the study (i.e., being on a controlled diet or dietary weight loss regimen)
- •- Intolerance or allergy to honey and bee products
- •- Pregnancy or breastfeeding
- •- Excessive alcohol intake >20 g of pure alcohol (2 drinks)/d on average (>21 standard drinks a week)
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