ISRCTN41607808已完成未知
Effect of a probiotic blend on bloating and colonic transit time in participants with self-reported bloating and constipation: a double-blind, randomized, placebo-controlled trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 156
研究概览
简要总结
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31131616 (added 29/05/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 18 - 70
- •2. Obtained his/her informed consent after verbal and written information
- •3. Sufficient general health and orientation for participating in the study
- •4. Have a high probability for compliance with and completion of the study
- •5. Functional constipation or constipation predominant IBS according to Rome III criteria
- •6. Bowel movement frequency 1-3/week
- •7. Stool consistency 1-2 according to Bristol Stool Scale Form for most spontaneously passed stools
- •8. Self-reported bloating at least twice a week
- •9. No continuous use of probiotics or probiotic containing product or drug within 1 month prior to screening
排除标准
- •1. Participation in a clinical trial with an investigational product or drug within 2 months prior to screening
- •2. Likeliness to be non-compliant with the protocol, or to be unsuitable to the study by the investigator for any reason
- •3. Planned major changes in life style (diet, exercise level, travelling)
- •4. Eating disorder
- •5. Pregnant or breastfeeding women; women planning to become pregnant during the study
- •6. Subject under administrative or legal supervision
- •7. Diagnosed or suspected organic gastrointestinal disease
- •8. Severely impaired general health including cancer and cancer therapy
- •9. Prior major abdominal surgery
- •10. Lactose intolerance if the subject does not follow a lactose-restricted diet
- •11. Previous anaphylaxis type reaction to any substance in composition of the study product
- •12. Consumption of or unwillingness to refrain from the use of commercial probiotics or prebiotics during the trial
- •13. Laxative use within 48 hours of screening and regular use of laxatives (rescue medication allowed for intolerable symptoms during study)
- •14. Regular use of any drug or dietary supplement known to cause constipation as a common side effect (e.g. iron, opioids, sucralfate misoprostol, 5-HT#-antagonists, antacids with magnesium, calcium or aluminum, anti-diarrheal medication, anti-cholinergic agents, calcium supplements, tricyclic anti-depressants or NSAIDs) within 1 month prior to the study randomization
- •15. History of drug or alcohol abuse
- •16. Subject has been on antibiotics within 1 month of screening visit
研究者
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