protocolSection identificationModule nctId: NCT06367504, orgStudyIdInfo id: DB/230904/DBMF/CDI, briefTitle: A Study to Assess the Effect of Doctor's Biome Medical Food in Individuals With Clostridium Difficile Infection, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Vedic Lifesciences Pvt. Ltd., class: INDUSTRY, descriptionModule briefSummary: 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), conditionsModule conditions: Clostridium Difficile Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, parallel group, double-blind, placebo-controlled trial, primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: DBMF, interventions name: Placebo, outcomesModule primaryOutcomes measure: To evaluate the effect of Investigational product on the duration of Clostridium difficile diarrhea in comparison to placebo., secondaryOutcomes measure: 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., secondaryOutcomes measure: 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., secondaryOutcomes measure: To assess the impact of the Investigational product on Number of non-CDI diarrhea episodes as compared to placebo, secondaryOutcomes measure: To assess the impact of the Investigational product on Number of SOC medication consumed (antibiotics therapy) throughout the intervention period as compared to placebo., secondaryOutcomes measure: To assess the impact of the Investigational product on Average number of days of consumption of SOC (antibiotics therapy) as compared to placebo., eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AIMS Hospital, city: Dombivali, state: Maharashtra, zip: 421203, country: India, contacts name: Dr Sandeep Kardian, MBBS MD, role: CONTACT, phone: 870364574, email: sandeepkadian@rediffgmail.com, geoPoint lat: 19.21667, lon: 73.08333, locations facility: Stress Test Clinic, city: Mumbai, state: Maharashtra, zip: 400059, country: India, contacts name: Dr Ramesh Dargad, MBBS MS, role: CONTACT, phone: 9820152828, email: rohitdargad@outlook.com, geoPoint lat: 19.07283, lon: 72.88261, locations facility: Nobel Hospital, city: Pune, state: Maharashtra, zip: 411013, country: India, contacts name: Dr Pramod Katare, MBBS MD, role: CONTACT, phone: 8830793201, email: drkatareps@gmail.com, geoPoint lat: 18.51957, lon: 73.85535, locations facility: Gleneagles Hospital, city: Hyderabad, state: Telangana, zip: 500004, country: India, contacts name: Dr G S Sameer Kumar, MBBS MD, role: CONTACT, phone: 8860031692, email: sameerzidane@gmail.com, geoPoint lat: 17.38405, lon: 78.45636, hasResults: False