NCT06730594已完成不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 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)
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
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals agreed to the signed and dated informed consent form.
- •Male and female individuals of age between 18 to 60 years (both values included)
- •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:
- •Fewer than three SBMs per week
- •Straining during more than ¼ (25%) of defecations
- •Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations
- •Sensation of incomplete evacuation more than ¼ (25%) of defecations
- •Sensation of anorectal obstruction/ blockage more than ¼ (25%) of defecations
- •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.
- •Individuals with concurrent chronic GI pathology (e.g. IBD, cystic fibrosis, short gut, celiac disease, frequent diarrhea without laxative).
- •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.
- •Individuals suffereing from Diabetic gastroparesis.
- •History of uncontrolled hypertension and/or systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg.
- •Individuals with impaired thyroid function reported by TSH less than 0.4 mIU/L and more than 5 mIU/L will be excluded. However, individuals on a stable dose of medication for past 6 months and within the aforementioned range, can be considered.
- •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.
研究组 & 干预措施
VL-BK-02 (25 billion CFU/Capsule)
Experimental
One capsule per day to be consumed orally before breakfast Duration: 84 days (12 weeks)
干预措施: VL-BK-02 (25 billion CFU/Capsule) (Dietary Supplement)
Placebo (Microcrystalline Cellulose - 375 mg/capsule)
Placebo Comparator
One capsule per day to be consumed orally before breakfast Duration: 84 days (12 weeks)
干预措施: Placebo (Microcrystalline Cellulose - 375 mg/capsule) (Dietary Supplement)
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)
时间窗: per week from baseline to the end of study visit.
Severe constipation is defined as no complete spontaneous bowel movements (CSBMs) and an average straining score ≥ 3.0 (CIC; 5-point scale) CSBM has emerged as an attractive symptom-specific primary endpoint for constipation trials, as it integrates the objective, quantitative sign of stool frequency and the subjective, qualitative symptom of sensation of complete defecation
次要结局
- To assess the effect of Investigational product (IP) in comparison to baseline and placebo on Quality of life by using Participant Assessment of Constipation QoL (PAC-QoL)(Baseline to day 14, day 28, day 42, day 56, day 70 and day 84.)
- To assess the effect of Investigational product (IP) in comparison to baseline and placebo on Stool consistency as assessed by Bristol Stool Form Scale (BSFS) per week from baseline to the end of study visit.(Baseline to Day 84)
- To assess the effect of Investigational product (IP) in comparison to baseline and placebo on Constipation symptoms by using Participant Assessment of Constipation Symptoms (PAC-SYM) from baseline to day 14, day 28, day 42, day 56, day 70 and day 84.(Baseline to day 14, day 28, day 42, day 56, day 70 and day 84.)
- To assess the effect of Investigational product (IP) in comparison to baseline and placebo Percentage responders are defined as the number of participants with an increase by 1 or more frequencies of CSBM from baseline to the end of intervention.(Baseline to Day 84)
- To assess the effect of Investigational product (IP) in comparison to baseline and placebo in Gut microbiome (alpha and beta diversity) from baseline to end of intervention.(Baseline to Day 84)
- To assess the effect of Investigational product (IP) in comparison to baseline and placebo Difference in the usage of rescue medication throughout the study duration as compared to placebo(through study completion, an average of Day 84)
研究者
研究点 (6)
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