DRKS00032096招募中Unknown
Gluten degrading-probiotic in the dietary management of symptomatic Celiac disease patients: a randomized, multicentric, placebo-controlled, double-blinded study - ProCeliac
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 100
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
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •BMI 17.5 – 35 kg/m2
- •- Non-smoker
- •- Past celiac disease diagnosis confirmed by medical report
- •- Gluten free diet (GFD) for at least two years
- •- Celiac disease patients with persistent IBS-type symptoms with no clinical evidence of other medical conditions to explain the symptoms
- •- IBS-SSS score of at least mild symptoms (IBS-SSS score = 75) during screening assessment
- •- Apart from celiac disease diagnosis, subject is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry, haematology
- •- Written consent to participate in the study
- •- Able and willing to follow the study procedures
- •- Visit 1: Confirmed at least mild symptoms during run-in phase (on average IBS-SSS score > 50)
排除标准
- •(1) Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.)
- •(2) Subject under prescription for medication or taking dietary supplements possibly interfering with this study (such as corticosteroids, anti-inflammatory drugs, anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries, fibers, probiotics etc.) within 4 weeks prior to study start or during the study. Stable doses of vitamin and mineral dietary supplements for at least 3 months is allowed.
- •(3) Intake of antibiotics in the last 3 months
- •(4) Use of PPIs in the last month prior to screening
- •(5) Significant changes in lifestyle or medication (within last 2 months) or surgical intervention
- •(6) Subjects consuming
- •food or drinks claimed as ‘probiotic’ more than once weekly
- •protein shakes more than once weekly
- •(7) Subjects with stool frequency of = 2 stools per week
- •(8) Subjects with history of drug, alcohol or other substance abuse within the last 5 years
- •(9) Relevant allergy or known hypersensitivity against compounds of the study preparations
- •(10) Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
- •(11) Anticipating any planned major changes in lifestyle, dietary habits or physical activity levels for the duration of the study
- •(12) Known pregnancy, breastfeeding or intention to become pregnant during the study. A pregnancy test will be conducted during screening and all visits at the study site
- •(13) Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
研究者
相似试验
已完成
不适用
Use of a Selected Mixture of Probiotic Strains for Degrading Gluten During DigestionProbioticsNCT05798689Free University of Bozen-Bolzano70
招募中
不适用
Gut Decision - Probiotics Interventiono clinical picture, healthy volunteersDRKS00017667Deutsche Sporthochschule Köln90
招募中
不适用
The effect of probiotics supplementation in type 1 diabetic patientsType 1 diabetes mellitus.Type 1 diabetes mellitusIRCT20201203049576N1Tehran University of Medical Sciences64
招募中
不适用
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)Nutrition Disorder, ChildCeliac Disease in ChildrenNCT06356220Boston Children's Hospital120
已完成
不适用
Probiotic VSL#3 as a treatment for food intolerant irritable bowel syndrome (IBS)Irritable bowel syndromeISRCTN72387688Department of Health20