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

Vedic Lifesciences

Status: Not yet enrolling

Conditions: Clostridium Difficile Infection

Treatments: Dietary Supplement: DBMF; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06367504

DB/230904/DBMF/CDI

Details and patient eligibility

About

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)

Enrollment: 20 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

20 participants in 2 patient groups, including a placebo group

Doctor's Biome Medical Food (DBMF)

Active Comparator group

Description:

Once a day daily 30 minutes before lunch

Treatment:

Dietary Supplement: DBMF

Placebo

Placebo Comparator group

Description:

Once a day daily 30 minutes before lunch

Treatment:

Dietary Supplement: Placebo