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

NCT06367504 | Not Yet Recruiting

• 1 other identifier: DB/230904/DBMF/CDI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief 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)

Conditions

Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

  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.

  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

  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.

  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.

  throughout the study during diarrhea episodes upto day 56

Study Arms (2)

Doctor's Biome Medical Food (DBMF)

ACTIVE COMPARATOR

Once a day daily 30 minutes before lunch

Dietary Supplement: DBMF

Placebo

PLACEBO COMPARATOR

Once a day daily 30 minutes before lunch

Dietary Supplement: Placebo

Interventions

DBMF DIETARY_SUPPLEMENT

Once a day daily 30 minutes before lunch

Doctor's Biome Medical Food (DBMF)

Placebo DIETARY_SUPPLEMENT

Once a day daily 30 minutes before lunch

Placebo

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females of 30 - 75 years of age.
• A qualifying episode of CDI as defined by:
• ≥ 3 abnormal stools as assessed by BSFS score of 6 \& 7 in the last 24 hours.
• A positive C. difficile stool toxin assay as assessed by C. difficile toxins A \& B - CARD\*.
• 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.
• \) 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

You may not qualify if:

• 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).
• History of peptic ulcer.
• History of abdominal surgery within the previous 3 months.
• Presence of colostomy, gastric-tube, or naso-gastric-tube.
• Individuals requiring any gastrointestinal surgery planned during the next 3 months.
• HIV, AIDS, primarily immunodeficiency, cancer
• Individuals with a very recent (\< 1 year) solid organ or bone marrow transplant.
• Individuals requiring blood transfusion or renal dialysis planned during the next 3 months.
• Unwilling to abstain using kombucha, sauerkraut, pickles and kimchi
• Individuals with the following food intolerance - gluten, lactose, and/or histamine.
• 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.
• Smokers.
• Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
• 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.
• Use of any supplements (may include probiotics, post-biotics, herbal supplements, synbiotics, enzyme supplementation the last 30 days.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (4)

AIMS Hospital

Dombivali, Maharashtra, 421203, India

Location

Stress Test Clinic

Mumbai, Maharashtra, 400059, India

Location

Nobel Hospital

Pune, Maharashtra, 411013, India

Location

Gleneagles Hospital

Hyderabad, Telangana, 500004, India

Location

MeSH Terms

Conditions

Clostridium Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Dr. Shalini Srivastava,, MBBS, MD

CONTACT

9920789140; shalini.s@vediclifesciences.com

Dr Shubhangi Mote, BAMS

CONTACT

8655448527; shubhangi.m@vediclifesciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, parallel group, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 16, 2024
• Study Start: July 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 30, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (4)