ISRCTN96068143已完成Unknown
Evaluation of the efficacy of a food supplement based on probiotics, vitamin PP and vitamin B2 in improving heartburn symptom/dyspeptic disorders and heartburn-related quality of life in subjects with mild to moderate gastroesophageal reflux disease (GERD): a randomized, double-blind, placebo-controlled clinical study
utratech Srl0 个研究点目标入组 56 人开始时间: 2024年1月31日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy male and female subjects aged 18 to 50 years old (inclusive), aware of the study procedures and having signed an informed consent form
- •2. Subjects who experienced mild or moderate heartburn according to Dyspepsia questionnaire (modified Leeds card)
- •3. Subjects used over-the-counter (OTC) products for heartburn, food supplements, or dietary manipulation to relieve heartburn symptoms during the previous 3 months
- •4. Willingness not to use products apart from the product tested throughout the study period and antiacids**
- •5. Willingness not to vary the normal daily routine (i.e. lifestyle, physical activity, usual diet, fluid intake etc)
- •6. Subjects under effective contraception (oral/not oral) therapy
- •7. Available and willing to follow the procedure of the study protocol
- •8. Subjects who have not been recently involved in any other similar study (at least 2 months of wash-out)
- •9. Subjects registered with the National Health Service (NHS)
- •10. Willingness to respect the instructions given by the investigator as well as to respect the study constraints and specific requirements
- •11. The pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) should be stable for at least 1 month without any changes expected or planned during the study
排除标准
- •1. Subjects not fulfilling the inclusion criteria above
- •2. Alimentary/eating disorders (i.e. bulimia, psychogenic eating disorders, etc)
- •3. Severe heartburn problem during the week prior to the study
- •4. Previous or current treatment for any gastrointestinal diseases or illnesses
- •5. Diagnosis of Barrett’s esophagus
- •6. Previous upper gastrointestinal surgery
- •7. Clinically significant GI bleeding within the last 3 months
- •8. Esophagitis not related to acid reflux
- •9. Known hypersensitivity or allergy to one of the active ingredients
- •10. Bleeding disorder, Zollinger–Ellison Syndrome, duodenal/gastric ulcer and upper gastrointestinal malignancy
- •11. Alcohol or drug abuse
- •12. Under pharmacological treatments (abuse of FANS, antibiotics, etc) known to interfere with the tested product
- •13. Clinical history with relevant presence of any disorder or administration of drugs/food supplement that can potentially interfere with the treatment under study
- •14. Pregnant or breastfeeding women
- •15. Known food intolerance or food allergy
- •16. Unstable medical diseases (cardiac arrhythmias or ischemia, uncontrolled hypertension and hypotension, diabetes mellitus, kidney failure)
- •17. History of paralysis or cerebral vascular accident
- •18. Subjects participating or planning to participate in other clinical trials
- •19. Adult protected by the law (under guardianship, or hospitalized in a public or private institution, for a reason other than the research, or incarcerated)
研究者
相似试验
已完成
不适用
Effects of Food supplement on Failure to Thrivefailure to thrive.Lack of Other lack of expected normal physiological developmentIRCT2015112125168N1Research and Technology Vice-Chancellory of Mashhad University of Medical Sciences70
进行中（未招募）
不适用
Testing plant-derived micronutrients (polyphenols) as food supplements to prevent/improve cognitive decline in ageing peopleElderly subjects with a score = 24 on the Mini-Mental State Examination (MMSE)Mental and Behavioural DisordersISRCTN10100061BIONAP srl120
已完成
不适用
The efficacy evaluation of the dietary supplement on movement of the knee joint and walking functioHealthy adultJPRN-UMIN000043053EP Mediate Co., Ltd.54
已完成
不适用
The efficacy evaluation of the dietary supplement on discomfort, bending and stretching of the low backoneJPRN-UMIN000037671TTC Co., Ltd54
已完成
不适用
The efficacy evaluation of the dietary supplement (composite material) on the low back pain and physicaloneJPRN-UMIN000036216TTC Co., Ltd70