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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
20
AIMS Hospital
Dombivali, Maharashtra, India
Stress Test Clinic
Mumbai, Maharashtra, India
Nobel Hospital
Pune, Maharashtra, India
Gleneagles Hospital
Hyderabad, Telangana, India
To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo.
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.
Time frame: Day 0, day 28 and day 56
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.
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.
Time frame: 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.
Bristol Stool Form Scale (BSFS), a simple and inexpensive tool that categorizes the stool into one of seven stool types ranging from type 1 (hard lumps) to type 7 (watery diarrhea). Stool consistency (diarrhea) serves as a surrogate marker for a C. difficile infection
Time frame: 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
Participants with frequency of ≥ 3 abnormal stools as assessed by BSFS stool type 6 \&/or 7 for 1 day will be analyzed for the presence of CDI using the CARD test.
Time frame: 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.
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Antibiotics induce adverse changes in gut microbiota, leading to a reduction in the absorption of short-chain fatty acids, resulting in osmotic, or watery, diarrhea
Time frame: 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.
Antibiotics induce adverse changes in gut microbiota, leading to a reduction in the absorption of short-chain fatty acids, resulting in osmotic, or watery, diarrhea
Time frame: throughout the study during diarrhea episodes upto day 56