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CTRI Number  CTRI/2024/06/068931 [Registered on: 14/06/2024] Trial Registered Prospectively
Last Modified On: 31/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to assess the effect of Doctor’s Biome Medical Food (DBMF) in individuals with Clostridium difficile infection (CDI) 
Scientific Title of Study   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) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
DB/230904/DBMF/CDI Version 1.0 Date 13th March, 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalini Srivastava 
Designation  Director – Clinical Development & Strategy 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053 India Mumbai MAHARASHTRA 400053 Mumbai MAHARASHTRA 400053 India

Mumbai
MAHARASHTRA
400053
India 
Phone  9920789140  
Fax    
Email  shalini.s@vediclifesciences.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shalini Srivastava 
Designation  Director – Clinical Development & Strategy 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053 India Mumbai MAHARASHTRA 400053 Mumbai MAHARASHTRA 400053 India

Mumbai
MAHARASHTRA
400053
India 
Phone  9920789140  
Fax    
Email  shalini.s@vediclifesciences.com  
 
Details of Contact Person
Public Query  
Name  Dr Shubhangi Mote 
Designation  Project Lead. 
Affiliation  Vedic Lifesciences Pvt. Ltd. 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053 India Mumbai MAHARASHTRA 400053 Mumbai MAHARASHTRA 400053 India

Mumbai
MAHARASHTRA
400053
India 
Phone  8655448527  
Fax    
Email  shubhangi.m@vediclifesciences.com  
 
Source of Monetary or Material Support  
Vedic Lifesciences Pvt. Ltd. 118-B, Morya House, off New Link Road, Andheri West Mumbai –400053, Maharashtra, India 
 
Primary Sponsor  
Name  Vedic Lifesciences Pvt. Ltd 
Address  Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053 India 
Type of Sponsor  Contract research organization 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandeep Kadian  AIIMS Hospital  0PD NO.1 Department of Medicines P/72, Milap Nagar, MIDC, Dombivali East, India
Mumbai
MAHARASHTRA 		 9870364574

drsandeepkadian@rediffmail.com 
Dr Ramesh Dargad  Dr Ramesh Dargad Clinic  G-1/A Bldg, Mukund Nagar CHS, Andheri - Kurla Rd, behind IDBI Bank, Vijay Nagar Colony, J B Nagar, Andheri East, Mumbai, Maharashtra 400059, India
Mumbai
MAHARASHTRA 		 9820152828

rohitdargad@outlook.com 
Dr G S Sameer Kumar  Gleneagles Hospital  Department GCRS 5th Floor, GCRS Room, 6-1-1040/1 to 4, Lakdikapul, Hyderabad, Telangana 500004, India
Hyderabad
TELANGANA 		 8860031692

sameerzidane@gmail.com 
Dr Pramod Katare  Noble Hospital  Department of gastroenterologist Room NO:ops-21 Ground Floor 153, Magarpatta city road, Hadapsar, Pune 411013, Maharashtra, India.
Pune
MAHARASHTRA 		 8830793201

drkatareps@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Altezza Institutional Ethics Committee  Approved 
Institutional Ethics Committee Gleneagles Global Hospitals  Submittted/Under Review 
Noble Hospital Institutional Ethics Committee  Submittted/Under Review 
Suraksha Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Doctor’s Biome Medical Food  One 2fl oz bottle (60 billion CFUs) Once a day daily 30 minutes before lunch Duration 56 day 
Comparator Agent  Placebo  Once a day daily 30 minutes before lunch Duration 56 day 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Males and females of 30 – 75 years of age
2.A qualifying episode of CDI as defined by
a.more than equal to 3 abnormal stools as assessed by BSFS score of 6 & 7 in the last 24 hours
b.A positive C. difficile stool toxin assay as assessed by C. difficile toxins A & B – CARD.
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 
 
ExclusionCriteria 
Details  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 ( less than 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. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of DBMF on the duration of Clostridium difficile diarrhea in comparison to placebo.  day 0, day 28, day 56 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the impact of the IP compared to baseline and placebo on: Number of CDI diarrhea episodes (presence of Clostridium difficile in stool samples as assessed by C. difficile toxins A & B - CARD) as compared to placebo  day 28 and day 56 
To assess the impact of the IP compared to baseline and placebo on: Change in the frequency of watery stool from Bristol Stool Form Scale (BSFS) score type 7 as compared to placebo.  throughout the study during diarrhea episodes 
To assess the impact of the IP compared to baseline and placebo on:Number of non-CDI diarrhea episodes as compared to placebo  day 28 & day 56 
To assess the impact of the IP compared to baseline and placebo on: Number of Standard of Care (SOC) medication consumed (antibiotics therapy) throughout the intervention period as compared to placebo  throughout the study during diarrhea episodes 
To assess the impact of the IP compared to baseline and placebo on: Average number of days of consumption of SOC (antibiotics therapy) as compared to placebo.  throughout the study during diarrhea episodes 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   20/08/2024 
Date of Study Completion (India) 19/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 19/03/2025 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The present study is a randomized, double-blind, placebo-controlled, pilot study. 192 participants will be screened, and considering a screening failure rate of 87%, approximately 28 participants will be randomized in a ratio of 1:1 to receive either DBMF or placebo and will be assigned a unique randomization code. Each group will have at least 10 completed participants after accounting for a dropout/withdrawal rate of 30%. The intervention duration for all the study participants is 56 days. 
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