CTRI/2024/06/068931尚未招募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) - Nil
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
- •1) 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.
研究者
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