EUCTR2018-001203-36-IE进行中（未招募）1 期
A Phase 2 Randomised, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study to Evaluate the Safety and Efficacy of Repeated Oral Doses of Blautix™ in Adult Subjects with Irritable Bowel Syndrome (IBS) Subtypes IBS-C and IBS-D
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 340
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All subjects must meet all of the following inclusion criteria:
- •1. Written consent on an Institutional Review Board (IRB)/ Independent Ethics Committee (IEC) approved ICF before any study specific evaluation
- •2. Males and Females between 18 and 70 years of age
- •3. Body Mass Index (BMI): 18-39 kg/m2
- •4. Having IBS-C or IBS-D as defined by Rome IV including Subtype Classification:
- •Recurrent abdominal pain on average, at least 1 day/week in the last 3 months associated with two or more of the following criteria:
- •Related to defecation
- •Associated with a change in frequency of stool
- •Associated with a change in form (appearance) of stool
- •The above criteria must be met for the last 3 months with symptom onset at least 6 months prior to diagnosis.
- •5. Have a moderate or severe IBS symptom severity score ; =175 at the screening visit as defined by IBS-SSS. A tolerance of -10% (= an IBS-SSS score of 157.5) will be allowable at the Baseline (Visit 1).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •Any of the following criteria will exclude the Subject from study participation:
- •1. Males or females <18 and >70 years of age
- •2. Have an IBS symptom severity score < 175 as defined by IBS-SSS
- •3. BMI: <18 or >39 kg/m2
- •4. Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrine, immunological, metabolic or any condition which contraindicates, in the investigators' judgment, entry to the study)
- •5. Confirmed clinical diagnosis of bile acid malabsorption and / or on medication for bile acid malabsorption
- •6. Individuals who, in the opinion of the investigator, are poor attendees or unlikely for any reason to be able to comply with the study requirements
- •7. Patient is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or patient is receiving other investigational agent(s)
- •8. Have an active or recent (within 3 years) malignant disease or any concomitant end-stage organ disease. A non-melanoma skin cancer that has been adequately treated with no recurrence within 3 months of screening is not excluded.
- •9. Females who are pregnant or breast feeding
- •10. Refusal to use acceptable methods of birth control (true abstinence, sterilisation, birth control pills, injections or contraceptive implants) for women of child bearing potential while on treatment and following completion of 2 menstrual cycles/ months after the last dose of study treatment. For Males, a barrier method of birth control from randomisation until the Follow-Up visit, unless vasectomised
- •11. Use of antibiotics within 30 days of screening
- •12. Use of systemic steroids within 30 days of screening
- •13. Change in dose or introduction of an antipsychotic within the last month
- •14. Have suffered from an uncontrolled or current major psychiatric disorder
- •15. Clinically diagnosed Lactose intolerance
- •16. Clinically diagnosed Coeliac disease
- •17. Change of diet e.g. FODMAP, gluten-free within last 3 months
- •18. Those > 50 will be excluded if their diagnosis of IBS is recent (<12 months) and if they have not had a sigmoidoscopy or colonoscopy within previous 5 years.
- •19. Any GI related abdominal surgery other than hernia repair or appendectomy. Cholecystectomy more than 6 months previously is not an exclusion
- •20. Subjects taking prucalopride
- •21. Known HIV infection, or hepatitis A, B, or C active infection
- •22. Subjects with abnormal laboratory values at screening deemed by the investigator to be clinically significant
- •23. Subjects who have taken commercially available probiotics within the last month (30 days prior to randomisation)
- •24. Subjects with known or suspected hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
- •25. Subjects taking guanylate cyclase agonists; such as linaclotide and lubiprostone
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