Dose Determination and Efficacy Evaluation of the Gastrointestinal ReProgramming (GaRP) Dietary supplement in IBS patients: A Randomized, Double-blind, Placebo-controlled clinical trial

Anatara Lifesciences0 个研究点目标入组 200 人开始时间: 2020年11月13日最近更新: 2024年9月9日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 200

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: Treatment
盲法: Blinded (masking used)

入排标准

年龄范围: 18 Years 至 65 Years（—）
性别: All

入选标准

•Patients who:
•Have irritable bowel syndrome with a moderate IBS-SSS score of 175-350 as assessed by the IBS-SSS questionnaire.
•Have IBS as defined by Rome IV
•recurrent abdominal pain on average at least 1 day/week in the last three months associated with two or more of the following:
•oRelated to defecation
•oAssociated with a change in frequency of stool
•oAssociated with a change in form of stool
•Have abdominal pain intensity where the weekly average of worst daily (in past 24 hours) abdominal pain score is > 30 on a 0 to 100-point scale at screening
•Agree not to make significant changes to their diet or exercise routines during the study.
•If a women of child-bearing potential, agrees to use an acceptable method of birth control (true abstinence, birth control pills, injections or contraceptive implants) while on treatment and following completion of 2 menstrual cycles or 2 months after the last dose of study treatment, and if male a barrier method of birth control from randomisation until the Follow- Up visit.

排除标准

•Participants who
•1. Have a body mass index of <18 or >39.9kg/m2.
•2. Have a significant acute or chronic coexisting illness such as psychiatric*,
•immunological or cardiovascular (not including controlled hypertension or
•stable endocrine considerations) that contraindicates, in the investigator’s
•judgement, entry to the study.
•a) Participants who have ‘alarm symptoms’ (e.g., unexplained weight
•loss family history of colon cancer or inflammatory bowel disease or
•rectal bleeding) may be eligible if organic pathology is excluded by a
•detailed work-up prior to enrolling the participant.
•b) * Participants with a psychiatric illness particularly in the category of
•chronic and non-psychotic, such as anxiety and /or depression, are
•eligible provided the investigator deems involvement will not to
•place the participant at risk and that the participant is considered
•3. Have confirmed clinical diagnosis of bile acid diarrhoea and/or are on
•medication for bile acid diarrhoea.
•4. Have IBS-C as defined by Rome IV Subtype Classification.
•5. Currently have, or have a history of, inflammatory bowel disease (e.g.,
•ulcerative colitis, Crohn’s disease), or have a faecal calprotectin level of >50
•ug/g at enrolment or C-reactive protein level of >5.0mg/L.
•6. Have diagnosed coeliac disease.
•7. Have had previous abdominal surgery (excluding laparoscopic
•cholecystectomy, appendectomy, hysterectomy, and hernia repair).
•8. Have radiation proctitis or other known poorly controlled medical conditions
•that could interfere with bowel function.
•9. Have a malignant disease (other than localised skin cancers) or any
•concomitant end-stage organ failure.
•10. In the opinion of the investigator, are poor attendees or unlikely for any
•reason to be able to comply with the study requirements.
•11. Are currently, or in the past 30 days have been, enrolled in another
•investigational device or drug study(s), or are currently receiving other
•investigational agent(s).
•12. Have used /weaned from long term systemic corticosteroids or antibiotics
•within the past month prior to screening or have used short -term systemic
•corticosteroids or antibiotics within the fourteen days prior to screening.
•13. Are taking narcotics (e.g., tramadol, codeine, morphine).
•14. Have changed their diet routine, e.g. FODMAP, gluten-free, within the past
•15. Are taking probiotics.
•16. Have chronic drug therapy that interferes with vitamin D metabolism, such
•as glucocorticoids, or have a chronic disease such as renal failure, liver
•disease, epilepsy or diabetes mellitus (except for possibly stable type 2
•diabetes where the medical management has been unchanged for >6
•months on a case-by-case basis in discussion with Principal Investigator, and
•only on the basis it is deemed not to put the participant at a higher risk of
•experiencing adverse reaction and/or interfere with the integrity of study
•outcomes) .
•17. Have experienced a cardiovascular event such as congestive heart failure,
•heart attack, stroke, or angina (chest pain) in the past 3 months.
•18. Require concomitant treatment with any prohibited medication. In
•accordance with Section 8.9, a participant may be permitted to enter the
另有 4 项未显示

研究者

发起方

Anatara Lifesciences

相似试验

已完成

不适用

Verification of the efficacy and effective dose of dietary fibers on postprandial blood glucose elevatioHealthy adults

JPRN-UMIN000034771KAGOME CO., LTD.14

进行中（未招募）

不适用

Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 years

EUCTR2011-001292-39-DEInstitut de Recherches Internationales Servier90

进行中（未招募）

不适用

Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 years

EUCTR2011-001292-39-HUInstitut de Recherches Internationales Servier90

进行中（未招募）

不适用

Determination of the efficacious and safe dose of ivabradine in paediatric patients with dilated cardiomyopathy and symptomatic chronic heart failure aged from 6 months to less than 18 yearsPaediatric dilated cardiomyopathy and symptomatic chronic heart failureMedDRA version: 14.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 10007541 - Cardiac disorders

EUCTR2011-001292-39-SEInstitut de Recherches Internationales Servier90

进行中（未招募）

1 期

EUCTR2011-001292-39-ESab Servier116