A Study to Assess the Effect of Doctor's Biome Medical Food in Individuals With Clostridium Difficile Infection

Launched by VEDIC LIFESCIENCES PVT. LTD. · Apr 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special medical food called Doctor's Biome Medical Food (DBMF) to see if it can help people with Clostridium difficile infection (CDI), which is a type of infection that affects the intestines and can cause severe diarrhea. The trial is designed to be fair and unbiased, meaning that some participants will receive the actual medical food while others will receive a placebo, which looks the same but doesn't contain the active ingredients. The study is not yet recruiting participants.

To be eligible for this study, you need to be between 30 and 75 years old and have been diagnosed with CDI, which is indicated by having more than three abnormal stools in a day and a positive test for the bacteria. If you decide to participate, you can expect to be monitored closely for your health and any changes after consuming the medical food. However, there are certain health conditions and recent treatments that may disqualify you from participating, such as serious kidney or liver issues, recent surgeries, or ongoing treatments like chemotherapy. If you're interested, it’s important to discuss your health history with your doctor to see if you qualify.

Gender

ALL

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.