NCT06367504UnknownNot Applicable
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)
Vedic Lifesciences Pvt. Ltd.4 sites in 1 country20 target enrollmentStarted: July 15, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
- Enrollment
- 20
- Locations
- 4
- Primary Endpoint
- To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo.
Study Overview
Brief 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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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
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.
- •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.
Arms & Interventions
Doctor's Biome Medical Food (DBMF)
Active Comparator
Once a day daily 30 minutes before lunch
Intervention: DBMF (Dietary Supplement)
Placebo
Placebo Comparator
Once a day daily 30 minutes before lunch
Intervention: Placebo (Dietary Supplement)
Outcomes
Primary Outcomes
To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo.
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Study Sites (4)
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