ISRCTN17149988已完成未知
Randomised, double-blind, placebo-controlled multi-centre study to assess the efficacy, tolerability and safety of Enterosgel® in the treatment of Irritable Bowel Syndrome with Diarrhoea (IBS-D) in adults (RELIEVE IBS-D)
Enteromed Ltd0 个研究点目标入组 439 人开始时间: 2017年11月15日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 439
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32000822/ (added 19/10/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35760493/ (added 28/06/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 04/04/2019:
- •1. Written informed consent
- •2. Irritable Bowel Syndrome with diarrhoea (IBS-D) according to Rome IV criteria
- •3. Aged 16-75
- •4. Considered suitable to take part in the study by the consenting doctor/nurse
- •5. Diary completed on at least 11 of 14 days (=75%) during the screening period
- •Previous inclusion criteria from 17/10/2018 to 04/04/2019:
- •1. Written informed consent
- •2. Irritable Bowel Syndrome with diarrhoea (IBS-D) according to Rome IV criteria
- •3. Aged 18-75
- •4. Considered suitable to take part in the study by the consenting doctor/nurse
- •5. Diary completed on at least 11 of 14 days (=75%) during the screening period
- •Original inclusion criteria:
- •1. Irritable Bowel Syndrome with diarrhoea (IBS-D) according to Rome IV criteria
- •2. Negative calprotectin test or adequate exclusion of Inflammatory Bowel Disease (IBD)
- •3. Aged 18+
- •4. Considered suitable to take part in the study by the consenting physician
排除标准
- •Current exclusion criteria as of 07/01/2020:
- •1. Loose stools (BSFS 6 or 7) on less than 3 days during the 14 days after Screening Visit
- •2. Average abdominal pain <2.5 during the 14 days after Screening Visit (scale 0–10: 0 = no pain; 10 = worst possible pain)
- •3. Previously diagnosed coeliac disease
- •4. Previously diagnosed Inflammatory Bowel Disease
- •5. Previous bowel cancer or bowel resection
- •6. Other previously known gastrointestinal disorder contributing to the diarrhoea
- •7. Unexplained weight loss
- •8. Unexplained rectal bleeding
- •9. Previous use of Enterosgel®
- •10. Use of antidepressant agents, unless used at a stable dose for at least 6 weeks
- •11. Use of any probiotic supplements, other intestinal adsorbents, slow-release medications or strong opioids
- •12. Participation in any research where treatment is provided, or was provided in the last three months
- •13. Pregnancy
- •Previous exclusion criteria from 04/04/2019 to 07/01/2020:
- •1. Loose stools (BSFS 6 or 7) on less than 3 days during the 14 days after Screening Visit
- •2. Average abdominal pain <3 during the 14 days after Screening Visit (scale 0–10: 0 = no pain; 10 = worst possible pain)
- •3. Previously diagnosed coeliac disease
- •4. Previously diagnosed Inflammatory Bowel Disease
- •5. Previous bowel cancer or bowel resection
- •6. Other previously known gastrointestinal disorder contributing to the diarrhoea
- •7. Unexplained weight loss
- •8. Unexplained rectal bleeding
- •9. Previous use of Enterosgel®
- •10. Use of antidepressant agents, unless used at a stable dose for at least 6 weeks
- •11. Use of any probiotic supplements, other intestinal adsorbents, slow-release medications or strong opioids
- •12. Participation in any research where treatment is provided, or was provided in the last three months
- •13. Pregnancy
- •Previous exclusion criteria from 17/10/2018 to 04/04/2019:
- •1. Loose stools (BSFS 6 or 7) on less than 3 days during the 14 days after Screening Visit
- •2. Average abdominal pain <3 during the 14 days after Screening Visit (scale 0–10: 0 = no pain; 10 = worst possible pain)
- •3. IBS-SSS=400
- •4. Previously diagnosed coeliac disease
- •5. Previously diagnosed Inflammatory Bowel Disease
- •6. Previous bowel cancer or bowel resection
- •7. Other previously known gastrointestinal disorder contributing to the diarrhoea
- •8. Unexplained weight loss
- •9. Unexplained rectal bleeding
- •10. Previous use of Enterosgel®
- •11. Use of antidepressant agents, unless used at a stable dose for at least 6 weeks
- •12. Use of any probiotic supplements, other intestinal adsorbents, slow-release medications or strong opioids
- •13. Participation in any research where treatment is provided, or was provided in the last three months
- •14. Pregnancy
- •Original exclusion criteria:
- •1. Loose stools (BSFS 6 or 7) on less than 3 days during the last 14 days
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