Clostridium Difficile InfectionNCT06367504
A Study to Assess the Effect of Doctor's Biome Medical Food in Individuals With Clostridium Difficile Infection
A study testing DBMF in people with Clostridium Difficile Infection, run by Vedic Lifesciences Pvt. Ltd. at 4 sites in India.
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) Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Clostridium Difficile Infection
- What is being tested?
- DBMF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 4 sitesIndia
- Study dates
- 15 Jul 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
4 sites in 1 country.
India4 sites
AIMS Hospital
Dombivali, Maharashtra, 421203
Dr Sandeep Kardian, MBBS MD, 870364574, sandeepkadian@rediffgmail.com
Gleneagles Hospital
Hyderabad, Telangana, 500004
Dr G S Sameer Kumar, MBBS MD, 8860031692, sameerzidane@gmail.com
Stress Test Clinic
Mumbai, Maharashtra, 400059
Dr Ramesh Dargad, MBBS MS, 9820152828, rohitdargad@outlook.com
Nobel Hospital
Pune, Maharashtra, 411013
Dr Pramod Katare, MBBS MD, 8830793201, drkatareps@gmail.com
About this study
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)
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
- Being tested
- DBMF, Placebo
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBMFDietary supplement
Once a day daily 30 minutes before lunch
PlaceboDietary supplement
Once a day daily 30 minutes before lunch
| Study group | Role | What they receive |
|---|---|---|
| Doctor's Biome Medical Food (DBMF) | Active comparator | Once a day daily 30 minutes before lunch Receives: Dietary Supplement: DBMF |
| Placebo | Placebo comparator | Once a day daily 30 minutes before lunch Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: throughout the study during diarrhea episodes upto day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start15 Jul 2024 (estimated)
- Primary completion15 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium Difficile InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel group, double-blind, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367504
- Sponsor's protocol ID
- DB/230904/DBMF/CDI
- Status last verified
- Mar 2024
- First submitted
- 5 Apr 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06367504
- Acronym / sponsor ID
- DB/230904/DBMF/CDI
- Conditions
- Clostridium Difficile Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel group, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Doctor's Biome Medical Food (DBMF) | Active comparator | Dietary Supplement: DBMFOnce a day daily 30 minutes before lunch |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOnce a day daily 30 minutes before lunch |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females of 30 - 75 years of age.
- A qualifying episode of CDI as defined by:
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBMFOnce a day daily 30 minutes before lunch | Dietary supplement | Doctor's Biome Medical Food (DBMF) |
| PlaceboOnce a day daily 30 minutes before lunch | Dietary supplement | Placebo |
Primary outcome
To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo.
Time frame: Day 0, day 28 and day 56
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.
5 secondary outcomes
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: throughout the study during diarrhea episodes upto day 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBMF in people with Clostridium Difficile Infection, run by Vedic Lifesciences Pvt. Ltd. at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Shalini Srivastava,, MBBS, MD (9920789140, shalini.s@vediclifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo. (time frame: Day 0, day 28 and day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.