Clinical trial NCT06367504: A Study to Assess the Effect of Doctor's Biome Medical Food in Individuals With Clostridium Difficile Infection
Official title: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Clostridium Difficile Infection
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-16
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel group, double-blind, placebo-controlled trial
Primary purpose: OTHER

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)


Eligibility criteria: Inclusion Criteria:

1. Males and females of 30 - 75 years of age.
2. A qualifying episode of CDI as defined by:

   1. ≥ 3 abnormal stools as assessed by BSFS score of 6 \& 7 in the last 24 hours.
   2. A positive C. difficile stool toxin assay as assessed by C. difficile toxins A \& B - CARD\*.
   3. 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:

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 (\< 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.

Primary outcomes:
measure: To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo.
timeFrame: Day 0, day 28 and day 56
Secondary outcomes:
measure: 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.
timeFrame: day 28 and day 56
measure: 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.
timeFrame: throughout the study during diarrhea episodes upto day 56
measure: To assess the impact of the Investigational product on Number of non-CDI diarrhea episodes as compared to placebo
timeFrame: day 28 and day 56
measure: To assess the impact of the Investigational product on Number of SOC medication consumed (antibiotics therapy) throughout the intervention period as compared to placebo.
timeFrame: throughout the study during diarrhea episodes upto day 56
measure: To assess the impact of the Investigational product on Average number of days of consumption of SOC (antibiotics therapy) as compared to placebo.
timeFrame: throughout the study during diarrhea episodes upto day 56
Other outcomes:
Locations:
city: Dombivali
country: India
facility: AIMS Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Stress Test Clinic
state: Maharashtra
city: Pune
country: India
facility: Nobel Hospital
state: Maharashtra
city: Hyderabad
country: India
facility: Gleneagles Hospital
state: Telangana
Study officials:
References: