CTRI/2025/01/079362招募中Phase 3 4
A Randomized, Double-Blind, Placebo-Controlled, Parallel Design Clinical Study to assess the Effect of the Bio-K+ Probiotic Capsules (VL-BK-02) in Adults with Functional Constipation
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 6
- 主要终点
- To assess the effect of VL-BK-02 on changes in the frequency of Complete Spontaneous Bowel Movements (CSBMs) per week
研究概览
简要总结
The present study is a randomized, placebo-controlled, double-blind, parallel-group clinical study designed to assess the effects of IP in individuals with Functional constipation as compared to a placebo. Approximately 205 individuals aged between 18 and 60 years will be screened. Considering a screen failure of 20%, approximately 164 individuals will be randomized in a ratio of 1:1 to receive either the active or placebo. The study will have at least 126 completed participants i.e. 63 partcipants in each study arm after accounting for a dropout/withdrawal rate of 23% at the end of the study. The intervention duration for all the study participants will be 56 days with follow up of upto 84 days. The study flow chart given below indicates the time points at which safety and efficacy assessments will be conducted
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants agreed to the signed and dated informed consent form.
- •2.Male and female individuals of age between 18 to 60 years.
- •3.Individuals who meet Rome IV diagnostic criteria for functional constipation as indicated by the criteria fulfilled for the last 3 months with symptoms onset at least 6 months prior to diagnosis: i.Must include two or more of the following criteria: a)Fewer than three SBMs per week b) Straining during more than ¼ (25%) of defecations c) Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations d) Sensation of incomplete evacuation more than ¼ (25%) of defecations e) Sensation of anorectal obstruction/ blockage more than ¼ (25%) of defecations f) Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor) ii.Loose stools are rarely present without the use of laxatives iii.
- •Insufficient criteria for irritable bowel syndrome
- •Individuals willing to comply with all study procedures and availability for the duration of the study as per the protocol.
- •Individuals willing to maintain the same dietary and physical activity practices throughout the study period.
- •Individuals with fewer than three CSBMs per week.
排除标准
- •Individuals with well-known, organic cause of constipation (Polyps, hemorrhoids, etc.)
- •Individuals with anorectal pathology.
- •Individuals with history of gastrointestinal surgery including appendisectomy.
- •Individuals with any alarming symptoms (i.e. rectal bleeding, weight loss, jaundice) as judged by the Investigator.
- •5.Individuals with concurrent chronic GI pathology (e.g. IBD, cystic fibrosis, short gut, celiac disease, frequent diarrhea without laxative).
- •6.Current pharmacological treatment related to constipation (e.g. prosecretory agents, antidepressants, antispasmodics, enterokinetic)
- •Individuals consuming dietary treatment (e.g. synbiotics, herbal extracts, fibers) or taking other therapies for treating constipation (e.g. cognitive behavior therapy, acupuncture, biofeedback, complementary and alternative Medicine) within 1 month prior to screening.
- •Use of antibiotics within 1 month prior to screening.
- •Use of products containing probiotics, prebiotics, postbiotics, within 1 month prior to screening.
- •Opioids-induced constipation.
- •Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT- antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or NSAIDs) within 1 month prior to screening.
- •Immuno-compromised participants.
- •Participants on immunosuppressive agents (e.g. heart or kidney transplant, chemotherapy agents, oral prednisolone)
- •History of cancer .
- •Individuals with known history of diabetes mellitus and are on medication for the same.
- •Psychiatric or behavioral disorders as judged by the Investigator
- •Individuals with known food allergy.
- •Individuals with eating disorders (e.g., anorexia, bulimia)
- •Pregnancy or lactation
- •Known allergic reactions to any components of the probiotics or placebo.
- •Individuals participating in other interventional study within 90 days prior to screening.
- •Individuals with a history of alcohol or drug abuse based on medical history, physical examination, or the Investigators clinical judgment.
- •Current Smokers.
- •Individuals with more than 14 SBMs per week.
结局指标
主要结局
To assess the effect of VL-BK-02 on changes in the frequency of Complete Spontaneous Bowel Movements (CSBMs) per week
时间窗: from baseline to the end of study visit.
次要结局
- To assess the effect of Investigational product (IP) in comparison to baseline & placebo on stool consistency as assessed by Bristol Stool Form Scale (BSFS) per week from baseline to the end of study visit.(from baseline to the end of study visit)
- To assess the effect of Investigational product (IP) in comparison Constipation symptoms by using Participant Assessment of Constipation Symptoms (PAC-SYM)(from baseline to day 14, day 28, day 42, day 56, day 70 & day 84.)
- To assess the effect of Investigational product (IP) in comparison Quality of life by using Participant Assessment of Constipation QoL (PAC-QoL)(from baseline to day 14, day 28, day 42, day 56, day 70 & day 84.)
- To assess the effect of Investigational product (IP) in comparison to Percentage responders defined as the number of participants with an increase by 1 or more frequencies of SBM with no sensation of incomplete evacuation(from baseline to the end of intervention)
- To assess the effect of Investigational product (IP) in comparison Gut microbiome (alpha & beta diversity)(from baseline to end of intervention)
- To assess the effect of Investigational product (IP) in comparison Difference in the usage of rescue medication(throughout the study duration as compared to placebo)
研究者
Dr Sanjay Vaze
Vedic Lifesciences Pvt Ltd
研究点 (6)
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