A Study to Assess the Effect of Doctor's Biome Medical Food in Individuals With Clostridium Difficile Infection
NCT ID: NCT06367504
Last Updated: 2024-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2024-07-15
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Doctor's Biome Medical Food (DBMF)
Once a day daily 30 minutes before lunch
DBMF
Once a day daily 30 minutes before lunch
Placebo
Once a day daily 30 minutes before lunch
Placebo
Once a day daily 30 minutes before lunch
Interventions
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DBMF
Once a day daily 30 minutes before lunch
Placebo
Once a day daily 30 minutes before lunch
Eligibility Criteria
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Inclusion Criteria
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
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.
30 Years
75 Years
ALL
Yes
Sponsors
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Vedic Lifesciences Pvt. Ltd.
INDUSTRY
Responsible Party
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Locations
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AIMS Hospital
Dombivali, Maharashtra, India
Stress Test Clinic
Mumbai, Maharashtra, India
Nobel Hospital
Pune, Maharashtra, India
Gleneagles Hospital
Hyderabad, Telangana, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DB/230904/DBMF/CDI
Identifier Type: -
Identifier Source: org_study_id
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