A Phase II Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicenter 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
- 2 期
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 67
- 主要终点
- Percentage of Participants With Overall Response
研究概览
简要总结
A study to evaluate the effectiveness of oral doses of Blautix in adult participants with irritable bowel syndrome (IBS).
详细描述
Participants with a diagnosis of IBS will be enrolled as defined by Rome IV criteria and will be classified into cohorts according to the Rome IV classification of IBS subtypes.
Each cohort (Cohort C and Cohort D) will recruit participants who will randomly receive either Blautix or matching placebo in a 1:1 ratio overall of treated to control participants.
Participants will undergo five visits in total across approximately 13 weeks. During the study treatment phase, participants will be asked to complete a variety of Quality of Life questionnaires at certain time points. These will consist of abdominal pain intensity score, IBS symptom severity (IBS-SSS), IBS quality of life (IBS-QoL), hospital anxiety and depression score (HADS), stool frequency, stool consistency & food frequency questionnaire.
Participants will be required to produce relevant blood, urine and faecal samples at pre-determined timepoints from screening through to End of Treatment and follow up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind trial design
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent on an Institutional Review Board (IRB)/ Independent Ethics Committee (IEC) approved informed consent form before any study specific evaluation
- •Males and Females between 18 and 70 years of age
- •Body Mass Index (BMI): 18-39 kg/m^2
- •Having IBS-C or IBS-D as defined by Rome IV* including Subtype Classification as defined in Table 2
- •* 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
- •Have a moderate or severe IBS symptom severity score (> 175) as defined by IBS-SSS
- •IBS -C Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score of > 3.0 on a 0 to 10-point scale And Stool Frequency: more than 25% of bowel movements with a consistency of Type 1 or Type 2 Bristol stool chart and less than 25% of bowel movements with Bristol stool form Type 6 or Type
- •Participants must have fewer than 3 complete spontaneous bowel movements (CSBMs) within a one week period (7 days)
- •IBS-D Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score of > 3.0 on a 0 to 10-point scale And Stool Consistency: more than 25% of bowel movements with a consistency of Type 6 or Type 7 Bristol stool chart and less than 25% of bowel movements with Bristol stool form Type 1 or Type 2.Participants must have at least one Type 6 or Type 7 bowel movements on at least four days within a one week period (7 days).
排除标准
- •Males or females <18 and >70 years of age
- •Have a IBS symptom severity score < 175 as defined by IBS-SSS
- •BMI: <18 or >39 kg/m^2
- •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)
- •Confirmed clinical diagnosis of bile acid malabsorption and / or on medication for bile acid malabsorption
- •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
- •Participant is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or participant is receiving other investigational agent(s)
- •Have a malignant disease or any concomitant end-stage organ disease.
- •Females who are pregnant or breast feeding
- •Refusal to use acceptable methods of birth control (true abstinence, sterilisation, birth control pills, injections or contraceptive implants) for fertile participants (females) 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
- •Use of antibiotics within 1 month of screening
- •Use of systemic steroids within the last month
- •Change in dose or introduction of an antipsychotic within the last month
- •Have suffered from a major psychiatric disorder
- •Clinically diagnosed Lactose intolerance
- •Clinically diagnosed Coeliac disease
- •Change of diet e.g. FODMAP, gluten-free within last 3 months
- •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.
- •Any gastrointestinal-related abdominal surgery other than hernia repair or appendectomy
- •Participants taking prucalopride
- •Other investigational procedures while participating in this study are excluded
- •Known HIV infection, or hepatitis A, B, or C active infection
- •Participants with abnormal laboratory values at screening deemed by the investigator to be clinically significant
- •Participants who have taken commercially available probiotics within the last month (30 days prior to randomization)
- •Participants with known or suspected hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltose insufficiency
- •Participants taking guanylate cyclase agonists, such as linaclotide and lubiprostone
结局指标
主要结局
Percentage of Participants With Overall Response
时间窗: Baseline up to Week 8
Overall responder was a participant who has at least 7 evaluable weeks of data and has reported an improvement in their weekly symptoms (abdominal pain intensity \[API\] and stool frequency \[SF\] or consistency \[SC\]) for greater than or equal to (\>=) 50 percent (%) of the treatment period. Improvement for abdominal pain intensity was defined as decrease in weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline for Cohort C and Cohort D, for stool frequency was defined as increase of 1 or more complete spontaneous bowel movements (CSBM) per week compared with baseline for Cohort C and for stool consistency was defined as decrease at least 50% in the proportion of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline for Cohort D. Participants with \<4 weeks available were considered non-responders.
次要结局
- Number of Participants With Response to Subject Global Assessment of Relief(Week 1, 4, 8, follow-up visit (Week 12, 13 and 14))
- Change From Baseline in Weekly Average Stool Frequency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14)(Baseline, Week 1, 4, 8, follow-up visit (Week 12, 13 and 14))
- Change From Baseline in Hospital Anxiety and Depression (HADS) Total Score at Week 4, 8 and Follow-up Visit (Weeks 12-14)(Baseline, Week 4, 8, follow-up visit (Weeks 12-14))
- Number of Participants With Treatment-Related Treatment-Emergent Adverse Events (TEAEs)(Baseline up to follow-up visit (up to Week 14))
- Percent Change From Baseline in Stool Consistency Assessed by Bristol Stool Form Scale (BSFS) at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14)(Baseline, Week 1, 4, 8, follow-up visit (Week 12, 13 and 14))
- Change From Baseline in IBS Quality of Life (IBS-QOL) Questionnaire Subscale and Total Scores at Week 4, 8 and Follow-up Visit (Weeks 12-14)(Baseline, Week 4, 8, follow-up visit (Weeks 12-14))
- Change From Baseline in IBS Symptom Severity Score (IBS-SSS) at Week 4, 8 and Follow-up Visit (Weeks 12-14)(Baseline, Week 4, 8, follow-up visit (Weeks 12-14))
- Change in Percentage of Days Per Week With Undesired Stool Consistency From Baseline at Week 1, 4, 8, Follow-up Visit (Week 12, 13 and 14)(Baseline, Week 1, 4, 8, follow-up visit (Week 12, 13 and 14))