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

Clostridium Difficile Infection Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06367504
• Other study ID #: DB/230904/DBMF/CDI
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: Vedic Lifesciences Pvt. Ltd.
• Contact: Dr. Shalini Srivastava,, MBBS, MD
• Phone: 9920789140
• Email: shalini.s[@]vediclifesciences.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 30, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections
• Communicable Diseases
• Infections

Intervention

Dietary Supplement:
• DBMF
Once a day daily 30 minutes before lunch
• Placebo
Once a day daily 30 minutes before lunch

Locations

Country	Name	City	State
India	AIMS Hospital	Dombivali	Maharashtra
India	Gleneagles Hospital	Hyderabad	Telangana
India	Stress Test Clinic	Mumbai	Maharashtra
India	Nobel Hospital	Pune	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Vedic Lifesciences Pvt. Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo.	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.	Day 0, day 28 and day 56
Secondary	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.	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.	day 28 and day 56
Secondary	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.	Bristol Stool Form Scale (BSFS), a simple and inexpensive tool that categorizes the stool into one of seven stool types ranging from type 1 (hard lumps) to type 7 (watery diarrhea). Stool consistency (diarrhea) serves as a surrogate marker for a C. difficile infection	throughout the study during diarrhea episodes upto day 56
Secondary	To assess the impact of the Investigational product on Number of non-CDI diarrhea episodes as compared to placebo	Participants with frequency of = 3 abnormal stools as assessed by BSFS stool type 6 &/or 7 for 1 day will be analyzed for the presence of CDI using the CARD test.	day 28 and day 56
Secondary	To assess the impact of the Investigational product on Number of SOC medication consumed (antibiotics therapy) throughout the intervention period as compared to placebo.	Antibiotics induce adverse changes in gut microbiota, leading to a reduction in the absorption of short-chain fatty acids, resulting in osmotic, or watery, diarrhea	throughout the study during diarrhea episodes upto day 56
Secondary	To assess the impact of the Investigational product on Average number of days of consumption of SOC (antibiotics therapy) as compared to placebo.	Antibiotics induce adverse changes in gut microbiota, leading to a reduction in the absorption of short-chain fatty acids, resulting in osmotic, or watery, diarrhea	throughout the study during diarrhea episodes upto day 56