CTRI/2025/03/082463招募中不适用
A randomized, placebo-controlled, double-blind clinical study to evaluate the efficacy of two different mixes of HMO-2-O-fucosyllactose (HMO-2FL) + Humiome Post LB postbiotic (postbiotic-LB) on Gastrointestinal Symptoms in individuals with Irritable Bowel Syndrome (IBS)
DSM Firmenich Switzerland Ltd19 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2025年3月29日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 19
- 主要终点
- To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2’-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on IBS symptoms as assessed by IBS Symptom Severity Scale (IBS-SSS), when compared to placebo in individuals with IBS
研究概览
简要总结
The present study is a randomized, double-blind, placebo-controlled, parallel group three arm study. The intervention duration for all the study participants is 6 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Written informed consent will be obtained before any study-related assessments 2.Male or female aged less than or equal to 18 to 70 years at the time of consent 3.Female individuals of childbearing potential (Females who are peri or post-menopausal ,when there has been no or irregular menstruation for a minimum of 12 months prior to screening, are considered not to be of child-bearing potential.), who are not surgically sterilized, must have a negative pregnancy test at screening and be willing to practice one of the following appropriate contraceptive methods until the last visit i.Sexual abstinence ii.Oral contraceptives.
- •iii.Trans-dermal patches or depot injection of a progestogen drug (starting at least 4 weeks prior to product administration).
- •iv.Double barrier method: condom or occlusive cap plus spermicidal agent.
- •Intrauterine device intrauterine system subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration/2 weeks prior screening).
- •Contraceptives must be effective before the randomization visit 4.Individuals with Plasma FBG (fasting blood glucose) (less than equal to 125 mg/dl).
- •5.Individuals with haemoglobin Hb (more than equal to 10 g/dl).
- •6.Individuals with BP (blood pressure) (less than equal to 140/100 mm Hg) 7.Individuals with normal haematology as assessed by CBC (complete blood counts) 8.Individuals with TSH levels in between 0.4 mIU/L and 5.0 mIU/L 9.SGOT and SGPT within 2 X the Upper normal limit (ULN) and serum creatinine within 1.5 X ULN 10.Rome-IV diagnostic criteria: Individuals with more than 25% of bowel movements with Bristol stool types 1, 2 or 6,7 and have had recurrent abdominal pain, on average, at least 1 day/week in the last 3 months.
- •The pain is associated with two or more of the following criteria: a.Related to defecation b.Associated with a change in frequency of stool c.Associated with a change in form or appearance of stool as assessed by Bristol stool type 1,2, 6 or 7 11.Abdominal pain severity (more than equal to 6 on a 11-point scale) at screening and during placebo run-in period.
- •12.Individuals with IBS-SSS score of at least 175 points at screening.
- •13.Individuals who are mentally stable as assessed by Perceived stress Scale (PSS) less than equal to 26 (Low to Moderate stress) 14.Individuals who understand the nature and purpose of the study including the potential risks and side effects.
- •15.Individuals who are willing to complete all study procedures including study related questionnaires and comply with study requirements.
- •16.Individuals who are capable of filling the app-based digital form/diary.
排除标准
- •1.Individuals with IBS-M.
- •2.Treatment with an investigational drug within 30 days/5 half-lives of the drug (whichever longest) prior to screening visit.
- •3.Individuals with organic disease like infectious diseases, inflammatory diseases, metabolic disorders, neurological diseases, autoimmune disorders, cancer 4.Individuals with a history of surgical resection of the stomach, small intestine or large intestine.
- •5.Individuals with a history of or complications from inflammatory bowel disease , colitis and enteritis.
- •6.Individuals with a history of any diet-based intolerance (gluten or lactose intolerance).
- •7.Individuals with a history of drug or alcohol abuse within the past 6 months.
- •8.Individuals with severe depression or an anxiety disorder, which could potentially affect the efficacy evaluation (as determined by the qualified investigator).
- •9.Individuals with uncontrolled hypertension or on antihypertensive medications 10.Individuals with serious cardiovascular diseases, respiratory diseases, renal diseases, hepatic diseases, gastrointestinal diseases (excluding IBS), blood diseases or neurological or psychiatric diseases.
- •11.Individuals who are pregnant, breastfeeding or planning on becoming pregnant throughout the course of the study.
- •12.Individuals with Type I or Type II diabetes mellitus.
- •13.Individuals with a history of or current diagnosis of any cancer diagnosed less than 5 years prior to screening.
- •Individuals with cancer in full remission more than 5 years after diagnosis are acceptable.
- •14.Individuals who are immuno-compromised (HIV positive, on anti-rejection medication, rheumatoid arthritis and other autoimmune disorders).
- •15.Individuals with a history of abdominal surgery.
- •16.Individuals with diarrhoea of any other origin.
- •17.Individuals currently or in future planning to fast for more than 24 hours.
- •18.Individuals with an active eating disorder.
- •19.Individuals who have used an over-the-counter or prescription laxative medication or any other herbal agents affecting GI motility within 2 weeks prior to screening.
- •20.Individuals who have used pre/pro/post/synbiotic, Human Milk Oligosaccharides (HMOs), or fiber supplements (or probiotic/fiber enriched foods) or FODMAP diet or an antibiotic within 4 weeks prior to screening.
- •21.Individuals who have used IBS specific treatments within 4 weeks prior to screening.
- •22.Individuals who currently consume greater than 2 standard alcoholic drinks per day from past 3 months.
- •(One unit of alcohol is equal to 45 ml of hard liquor, 150 ml of wine or a pint of beer) 23.Smokers (in any number and any format) 24.Individuals with an allergy or sensitivity to the probiotic products.
- •25.Individuals who are cognitively impaired and/or who are unable to give an informed consent.
- •26.Individuals who have abnormal laboratory results or any other medical or psychological condition which, in the opinion of the qualified investigator, may adversely affect the Individuals’ ability to complete the study or its measures or which may pose significant risk to the individual.
结局指标
主要结局
To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2’-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on IBS symptoms as assessed by IBS Symptom Severity Scale (IBS-SSS), when compared to placebo in individuals with IBS
时间窗: Day 0, and Day 42
次要结局
- To assess the efficacy of daily consumption of two different mixes of HMO 2’-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB) on IBS symptoms as assessed by IBS Symptom Severity Scale (IBS-SSS), when compared to placebo in individuals with IBS(Day 0, Day 21)
- To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2’-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on IBS symptoms as assessed by IBS-SSS, when compared to baseline in individuals with IBS(Day 0, Day 21 and Day 42)
- To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2’-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on the following parameters compared to baseline, each other and placebo in individuals with IBS(1.Abdominal pain severity (11-point scale))
- To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2’-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on the following parameters compared to baseline, each other and placebo in individuals with IBS(1.Daily number of stools (stool frequency).)
- To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2’-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on the following parameters compared to baseline, each other and placebo in individuals with IBS(1.IBS-related mental stress relief as assessed by the Perceived Stress Scale (PSS))
- To assess the efficacy of 6 weeks of daily consumption of two different mixes of HMO 2’-O-fucosyllactose (HMO-2FL) + Humiome® Post LB postbiotic (postbiotic-LB); on the following parameters compared to baseline, each other and placebo in individuals with IBS(1.Change in gut microbiome composition at genus and/ or species level.)
研究者
Dr Sanjay Vaze
Vedic Lifesciences Pvt Ltd
研究点 (19)
Loading locations...
相似试验
尚未招募
3 期
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimers DiseaseCTRI/2025/11/097417Karuna Therapeutics, Inc., a Bristol-Myers Squibb company366
招募中
3 期
A Phase 3 Study of Barzolvolimab in Patients with Chronic Spontaneous Urticaria (EMBARQ-CSU2)CTRI/2025/01/079061Celldex Therapeutics, Inc.915
招募中
不适用
To assess the effect of Libifem® (VL-GF-01) on Fertility in Women with Diminished Ovarian Reserve.CTRI/2025/02/080850Vedic Lifesciences Pvt. Ltd150
尚未招募
不适用
Comparing lycopus virginicus 30C and individualized homoeopathic treatment for managing early stage high blood pressure in adults-A study with a placebo groupCTRI/2025/08/093312Swasthya kalyan homoeopathic medical college and research centre105
招募中
4 期
Sarilumab Efficacy and Safety in Adults With Early Polymyalgia RheumaticaPolymyalgia RheumaticaNCT07286214Sanofi300