NCT06367504Unknown不适用
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)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo.
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females of 30 - 75 years of age.
- •A qualifying episode of CDI as defined by:
- •≥ 3 abnormal stools as assessed by BSFS score of 6 & 7 in the last 24 hours.
- •A positive C. difficile stool toxin assay as assessed by C. difficile toxins A & B - CARD*.
- •The requirement of CDI Standard of Care (SOC) antibiotic therapy (as per PI's discretion). 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).
- •History of peptic ulcer.
- •History of abdominal surgery within the previous 3 months.
- •Presence of colostomy, gastric-tube, or naso-gastric-tube.
- •Individuals requiring any gastrointestinal surgery planned during the next 3 months.
- •HIV, AIDS, primarily immunodeficiency, cancer
- •Individuals with a very recent (< 1 year) solid organ or bone marrow transplant.
- •Individuals requiring blood transfusion or renal dialysis planned during the next 3 months.
- •Unwilling to abstain using kombucha, sauerkraut, pickles and kimchi
- •Individuals with the following food intolerance - gluten, lactose, and/or histamine.
- •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.
- •Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- •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.
- •Use of any supplements (may include probiotics, post-biotics, herbal supplements, synbiotics, enzyme supplementation the last 30 days.
研究组 & 干预措施
Doctor's Biome Medical Food (DBMF)
Active Comparator
Once a day daily 30 minutes before lunch
干预措施: DBMF (Dietary Supplement)
Placebo
Placebo Comparator
Once a day daily 30 minutes before lunch
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo.
时间窗: Day 0, day 28 and day 56
The Clostridium difficile Toxin A+B Card is a non-invasive, rapid immunochromatographic test for detecting toxins A and B in stool samples for making a presumptive diagnosis of Clostridium difficile infection.
次要结局
- To assess the impact of the Investigational product on Number of CDI diarrhea episodes presence of Clostridium difficile in stool samples as assessed by C. difficile toxins A & B - CARD.(day 28 and day 56)
- To assess the impact of the Investigational product on Change in the frequency of watery stools from Bristol Stool Form Scale (BSFS) score type 7 as compared to placebo.(throughout the study during diarrhea episodes upto day 56)
- To assess the impact of the Investigational product on Number of non-CDI diarrhea episodes as compared to placebo(day 28 and day 56)
- To assess the impact of the Investigational product on Number of SOC medication consumed (antibiotics therapy) throughout the intervention period as compared to placebo.(throughout the study during diarrhea episodes upto day 56)
- To assess the impact of the Investigational product on Average number of days of consumption of SOC (antibiotics therapy) as compared to placebo.(throughout the study during diarrhea episodes upto day 56)
研究者
研究点 (4)
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