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

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)

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 Overview

• Status: Not yet recruiting
• Conditions: Clostridium Difficile Infection
• Intervention / Treatment: Dietary supplement: DBMF; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Shalini Srivastava,, MBBS, MD; Phone Number: 9920789140; Email: shalini.s@vediclifesciences.com
• Study Contact Backup: Name: Dr Shubhangi Mote, BAMS; Phone Number: 8655448527; Email: shubhangi.m@vediclifesciences.com

Study Locations

• India
  • Maharashtra
    • Dombivali, Maharashtra, India, 421203
      • AIMS Hospital
      • Contact: Dr Sandeep Kardian, MBBS MD; Phone Number: 870364574; Email: sandeepkadian@rediffgmail.com
    • Mumbai, Maharashtra, India, 400059
      • Stress Test Clinic
      • Contact: Dr Ramesh Dargad, MBBS MS; Phone Number: 9820152828; Email: rohitdargad@outlook.com
    • Pune, Maharashtra, India, 411013
      • Nobel Hospital
      • Contact: Dr Pramod Katare, MBBS MD; Phone Number: 8830793201; Email: drkatareps@gmail.com
  • Telangana
    • Hyderabad, Telangana, India, 500004
      • Gleneagles Hospital
      • Contact: Dr G S Sameer Kumar, MBBS MD; Phone Number: 8860031692; Email: sameerzidane@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Doctor's Biome Medical Food (DBMF); Once a day daily 30 minutes before lunch	Dietary supplement: DBMF; Once a day daily 30 minutes before lunch
Placebo Comparator: Placebo; Once a day daily 30 minutes before lunch	Dietary supplement: Placebo; Once a day daily 30 minutes before lunch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): December 15, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Clostridium Infections
• Other Study ID Numbers: DB/230904/DBMF/CDI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No