A clinical study determining the safety and gut health benefits of a new variety of barley in participants with coeliac disease

CSIRO Health and Biosecurity0 个研究点目标入组 62 人开始时间: 2018年3月16日最近更新: 2019年11月11日

适应症

试验速览

阶段: 未知
状态: 招募中
发起方
入组人数: 62

研究概览研究设计入排标准研究者记录与标识符相似试验

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: Prevention
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

•Medically diagnosed coeliac disease (CD)
•Have followed a GF diet for at least 2 years confirmed by history and normal CD serology (see exclusion criteria for normal range) from sample collected at screening visit
•Males and females aged 18-75 years
•No history of illness for the past 4 weeks which will affect their fitness for endoscopy, and any diarrhoeal illness
•Understand the study and agree to participate
•Are prepared to adhere to gluten free diet for the 12 weeks of the run-in and study
•Able to attend FMC (or Noarlunga Hospital) on 4 occasions during the study
•Prepared to undergo 2 endoscopies
•Willing to consume one serve of about 60g of investigational product daily for 8 weeks

排除标准

•Refractory coeliac disease (CD), severe CD complications (eg enteropathy associated T-cell lymphoma or active dermatitis herpetiformis lesions at the time of screening)
•Screening CD antibody serology results outside normal range: participants excluded if deamidated gliadin IgG (AGA) is >11 units/mL or if anti-tissue transglutaminase antibody (tTG-IgA) is >11 units/mL
•Other chronic inflammatory or functional gastrointestinal disease (eg symptomatic gastrointestinal reflux disease, inflammatory bowel disease, functional bowel disorders)
•Uncontrolled diabetes or autoimmune, psychiatric, neurological disease or chronic disease (eg HIV-AIDS or cancer other than skin cancer) that could interfere with assessments
•Extended absences due to travel or other commitments
•Reported lactating, pregnant or wish to become during the study. If a participant becomes pregnant during the trial they will be withdrawn
•Other than oral contraceptives use of other medications or over-the-counter supplements that in the opinion of the gastroenterologist may interfere with study outcomes, including antibiotics, non-steroidal anti-inflammatory drugs, medications that alter microbiota function for 2 months prior to and during the clinical intervention. Stable regular dose of non-steroidal anti-inflammatory drugs that were commenced prior to screening visit are allowed with approval of the Principal Investigator.
•Use of any immunosuppressive medications for 6 months prior to and during the clinical intervention
•Use of warfarin or enoxaparin. Use of direct oral anticoagulants like xarelto, apixaban, rivoraxaban and antiplatelet medications like clopidogrel, prasugrel and ticagrelor. Use of aspirin is allowed
•Received any experimental drug within 14 days of randomisation; in the case of biologics at least 6 months prior to randomisation

研究者

发起方

CSIRO Health and Biosecurity

相似试验

招募中

2 期

Clinical investigation of Topaz hair strengthening solution in preventing and improving hair lossHair loss.Nonscarring hair loss, unspecifiedL65.9

IRCT20210130050179N5Qeshm Rojin Company20

招募中

2 期

Clinical investigation of the safety and effectiveness of Excilia Hair strengthening and ani hair loss Lotion in improving hair lossHair loss.Nonscarring hair loss, unspecifiedL65.9

IRCT20210130050179N6Zist orchid pharmed Company25

尚未招募

1 期

A single center clinical study of evaluating the injection of microRNA2911 plasmid in healthy adultsovel Coronavirus Pneumonia (COVID-19)

ITMCTR2000003169anjing University

进行中（未招募）

不适用

Study to evaluate the safety of human immune globulin in patients withprimary immunodeficiency diseases.

EUCTR2011-005015-82-Outside-EU/EEAOctapharma AG20

尚未招募

1 期

Clinical study to assess the safety and tolerability of administration, directly into a vein, of human umbilical cord and placental blood plasma (Plasmacord®) in patients with Severe acute respiratory syndrome resulting from Sars-Cov-2 infection (fever, cough headache, muscle aches and difficulty breathing)

RBR-4pfygrCRYOPRAXIS - CRIOBIOLOGIA LTDA