CTRI/2024/06/068931已完成2 期
A randomized, double-blind, placebo-controlled, pilot clinical study to assess the effect of Doctor’s Biome Medical Food (DBMF) in individuals with Clostridium difficile infection (CDI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- To evaluate the effect of DBMF on the duration of Clostridium difficile diarrhea in comparison to placebo.
研究概览
简要总结
The present study is a randomized, double-blind, placebo-controlled, pilot study. 192 participants will be screened, and considering a screening failure rate of 87%, approximately 28 participants will be randomized in a ratio of 1:1 to receive either DBMF or placebo and will be assigned a unique randomization code. Each group will have at least 10 completed participants after accounting for a dropout/withdrawal rate of 30%. The intervention duration for all the study participants is 56 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males and females of 30 – 75 years of age 2.A qualifying episode of CDI as defined by a.more than equal to 3 abnormal stools as assessed by BSFS score of 6 & 7 in the last 24 hours b.A positive C.
- •difficile stool toxin assay as assessed by C.
- •difficile toxins A & B – CARD.
- •3.Individuals willing to give voluntary, written informed consent to participate in the study.
- •4.Individuals without/with antibiotic-associated diarrhea (indicated by use of antibiotics any time in last one week) will also be considered for the testing of C.
- •difficile toxins.
排除标准
- •History or presence of terminal/end-stage renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders (which might confound the interpretation of the study results, or put the individual at undue risk). 2) History of peptic ulcer. 3) History of abdominal surgery within the previous 3 months. 4) Presence of colostomy, gastric-tube, or naso-gastric-tube 5) Individuals requiring any gastrointestinal surgery planned during the next 3 months. 6) HIV, AIDS, primarily immunodeficiency, cancer 7) Individuals with a very recent ( less than 1 year) solid organ or bone marrow transplant. 8) Individuals requiring blood transfusion or renal dialysis planned during the next 3 months. 9) Unwilling to abstain using kombucha, sauerkraut, pickles and kimchi. 10) Individuals with the following food intolerance.
- •gluten, lactose, and/or histamine. 11) Heavy alcohol drinkers are defined as follows: For men, consuming more than 4 drinks on any day or more than 14 drinks/week. For women, consuming more than 3 drinks on any day or more than 7 drinks/week. 12) Smokers. 13) Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. 14) Individuals who have participated in another clinical study(ies) with an investigational product within 90 days before screening, or who plan to participate in another study during the study period. 15) Use of any supplements (may include probiotics, post-biotics, herbal supplements, synbiotics, enzyme supplementation the last 30 days.
结局指标
主要结局
To evaluate the effect of DBMF on the duration of Clostridium difficile diarrhea in comparison to placebo.
时间窗: day 0, day 28, day 56
次要结局
- To assess the impact of the IP compared to baseline and placebo on: Number of CDI diarrhea episodes (presence of Clostridium difficile in stool samples as assessed by C. difficile toxins A & B - CARD) as compared to placebo(day 28 and day 56)
- To assess the impact of the IP compared to baseline and placebo on: Change in the frequency of watery stool from Bristol Stool Form Scale (BSFS) score type 7 as compared to placebo.(throughout the study during diarrhea episodes)
- To assess the impact of the IP compared to baseline and placebo on:Number of non-CDI diarrhea episodes as compared to placebo(day 28 & day 56)
- To assess the impact of the IP compared to baseline and placebo on: Number of Standard of Care (SOC) medication consumed (antibiotics therapy) throughout the intervention period as compared to placebo(throughout the study during diarrhea episodes)
- To assess the impact of the IP compared to baseline and placebo on: Average number of days of consumption of SOC (antibiotics therapy) as compared to placebo.(throughout the study during diarrhea episodes)
研究者
Dr Shalini Srivastava
Vedic Lifesciences Pvt. Ltd.
研究点 (4)
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