A Study to Assess the Effect of Doctor's Biome Medical Food in Individuals With Clostridium Diffi… (NCT06367504) | Clinical Trial Compass
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A Study to Assess the Effect of Doctor's Biome Medical Food in Individuals With Clostridium Difficile Infection
India20 participantsStarted 2024-07-15
Plain-language summary
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)
Who can participate
Age range30 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo.