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临床试验/CTRI/2024/05/067212
CTRI/2024/05/067212已完成4 期

A randomized, double blind, placebo controlled, parallel group clinical study to assess effects of pasteurized Akkermansia muciniphila vs. placebo in participants with moderate to severe diarrhea-predominant irritable bowel syndrome (PAM – DIGEST)

The Akkermansia Company16 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2024年5月21日最近更新:
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试验速览

阶段
4 期
状态
已完成
入组人数
380
试验地点
16
主要终点
To assess the impact of pasteurized Akkermansia muciniphila relative to placebo on percentage responders in terms of improvement of the IBS-Symptom Severity Scores (SSS) in participants with moderate to severe diarrhea-predominant irritable bowel syndrome. [A responder is defined as a participant who has a decrease in IBS-SSS of at least 50 points (minimal clinically important difference or MCID)].
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The present study is a randomized, double-blind, placebo-controlled, parallel group clinical study. Up to around 475 individuals will be screened, and considering a screening failure rate of 20%, approximately 380 will be randomized in a ratio of 1:1 to receive either pasteurized A. muciniphila (pAKK) or matching placebo after a post-screening 14-day placebo run-in phase. Each group will have at least 152 completed participants (total 304 completers) after accounting for a dropout/withdrawal rate of 20%. The intervention duration for all the study participants is 12 weeks (intervention phase). Subsequently, the participants will be invited to return to site for an end of study assessment after 14 days of no intervention (post-intervention phase).

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)（—）
性别
All

入选标准

  • •Men and women from 18 to 55 years old.
  • •Individuals diagnosed for IBS within the last two years, and meets Rome-IV criteria for IBS: recurrent abdominal pain on average ≥1 day/week in ≥3 months prior to study (with symptom onset ≥6 months prior to study), associated with ≥2 of the following criteria: a.
  • •Related to defecation b.
  • •Associated with a change in frequency of stool c.
  • •Associated with a change in form (appearance) of stool.
  • •Has IBS-D, i.e., more than one-fourth (25%) of bowel movements with Bristol stool types 6 or 7 and less than one-fourth (25%) of bowel movements with Bristol stool types 1 or 2); in other words, put practically and as per FDA: at least 2 days per week with at least one stool that has a consistency of Type 6 or Type 7 BSS.
  • •Has an IBS-SSS of at least 175 points at screening.
  • •Individuals either with abdominal pain or discomfort (≥ 6 to ≤ 10 on an 11-point scale).
  • •Has had no prior line of conventional intervention for IBS or dietary change in the last 4 weeks before screening (e.g., low FODMAP, soluble fibers, antispasmodics, laxatives, obstipants, serotonin agonist/antagonist) i.e., recently diagnosed individuals.
  • •Individuals’ agreement to comply with study procedures, in particular: a.
  • •to take IP as recommended, b.
  • •to avoid the use of other products which may influence the gastrointestinal (GI) complaints, mental symptoms or commensal flora during the study as defined in Section 6.8 Prior and Concomitant Therapy, c.
  • •to keep the habitual dietary habits, level of physical activity as well as the level of caffeine or nicotine (if any), d.
  • •to complete the individual’s diary and study questionnaires.
  • •Women of childbearing potential: a.
  • •commitment to use contraception methods, b.
  • •Negative pregnancy testing (beta human chorionic gonadotropin test in urine).
  • •Readiness not to participate in another clinical study during this study.
  • •Participation is based upon written informed consent by the individual following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.

排除标准

  • •Known allergy or hypersensitivity to the components of the investigational product.
  • •Lactose or fructose intolerance
  • •Individuals with uncontrolled hypertension as assessed by systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100mmHg.
  • •History of diverticulitis, intestinal obstruction, stricture, toxic megacolon, GI (gastro-intestinal) perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g., aorto-iliac disease) or recent unexplained GI bleeding within 3 months prior to screening.
  • •History of malignancy within 3 years before screening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
  • •History and/or presence of acute or chronic significant GI disease or digestion/absorption disorders (e.g., inflammatory bowel disease, coeliac disease, Clostridium difficile colitis, pancreatitis, disorders in digestive tract motility, gluten enteropathy, etc.)
  • •Major gastric, hepatic, biliary, pancreas or intestinal surgery within the last 6 months prior to screening or planned during the study (appendectomy, hemorrhoidectomy, or polypectomy allowed as long as occurred more than 3 months prior to study screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred more than 3 months prior to screening).
  • •Clinically significant findings in colonoscopy within the 3 years prior to study.
  • •Family history among first degree relatives of colorectal cancer or inflammatory bowel disease.
  • •Individuals diagnosed with psychiatric disease (e.g., bipolar disorder, Schizophrenia) with or without medication in the last three years.
  • •Individuals currently on medication for anxiety and/or depression.
  • •Individual has a history and/or presence of other clinically significant condition/disorder, which per investigator’s judgement could interfere with the results of the study or the safety of the participants, e.g.: a.
  • •thyroid gland disorder b.
  • •hypertension c.
  • •diabetes mellitus d.
  • •eating disorder e.
  • •immunodeficiency f.
  • •relevant gynecological or urological disorder g.
  • •any other relevant serious organ or systemic diseases ( e.g., cardiovascular, respiratory, liver, renal, neurological disease, etc.)
  • •Regular medication and/or supplementation within the last month prior to and planned during the study: a.
  • •medication for IBS complaints, e.g., bile acid binders (cholestyramine), rifaximin, alosetron, lubiprostone, eluxadoline and linaclotide c.
  • •which could influence gastrointestinal functions (e.g., laxatives, opioids, systemic corticosteroids, anti-cholinergics, anti-diarrheals, proton pump inhibitors, H2-blockers, etc.) as per investigator judgement.
  • •Regular use of psychopharmaca (e.g., hypnotics / sedative drugs, anxiolytics, antidepressants, neuroleptics, anticonvulsants) within 3 months prior to study or adaptogens (e.g., ginseng, Ashwagandha, satavari, St. John’s Wort) within 6 weeks prior to and during the study.
  • •Women of child-bearing potential: pregnancy or nursing.
  • •History of or current abuse of drugs, alcohol, tobacco/nicotine or medication.
  • •Participation in another study during the last 30 days prior to and during the study.
  • •Any other reason for exclusion as per investigator’s judgment, e.g., insufficient compliance with study procedures.

结局指标

主要结局

To assess the impact of pasteurized Akkermansia muciniphila relative to placebo on percentage responders in terms of improvement of the IBS-Symptom Severity Scores (SSS) in participants with moderate to severe diarrhea-predominant irritable bowel syndrome. [A responder is defined as a participant who has a decrease in IBS-SSS of at least 50 points (minimal clinically important difference or MCID)].

时间窗: Baseline (Day 0), and Week 12 (Day 84)

次要结局

  • To assess the impact of pasteurized Akkermansia muciniphila relative to placebo on the proportion of percentage of participants who are responders in terms of improvement of the IBS-SSS from baseline at week 8.(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
  • To assess the impact of pasteurized Akkermansia muciniphila relative to placebo on Generalized Anxiety Disorder (GAD)-7 score(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
  • To assess the impact of pasteurized Akkermansia muciniphila relative to placebo on The proportion of percentage of participants who are responders in terms of improvement of the GAD -7 score.(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
  • To assess the impact of pasteurized Akkermansia muciniphila relative to placebo on Patient Health Questionnaire (PHQ)-9 score(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
  • To assess the impact of pasteurized Akkermansia muciniphila relative to placebo on the proportion of percentage of participants who are responders in terms of improvement of the PHQ-9 score(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
  • To assess the impact of pasteurized Akkermansia muciniphila relative to placebo on Perceived Stress Scale (PSS)(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
  • To assess the impact of pasteurized Akkermansia muciniphila relative to placebo on Bristol Stool Form Score (BSFS)(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
  • To assess the impact of pasteurized Akkermansia muciniphila relative to placebo on IBS-Quality of Life (IBS-QoL)(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
  • To assess the impact of pasteurized Akkermansia muciniphila relative to placebo on IBS-SSS value(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
  • To assess the impact of pasteurized Akkermansia muciniphila relative to placebo on Compliance with the intake of the investigational product(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))
  • To assess the impact of pasteurized Akkermansia muciniphila relative to placebo on Safety and tolerance(Baseline (Day 0), Week 4 (Day 28), Week 8 (Day 56), Week 12 (Day 84), Week 15 (Day 105))

研究者

申办方类型
Pharmaceutical industry-Global
责任方
Principal Investigator
主要研究者

Dr Shalini Srivastava

Vedic Lifesciences Pvt. Ltd.

研究点 (16)

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