protocolSection identificationModule nctId: NCT06346847, orgStudyIdInfo id: TAC/231001/AKM/IBS, secondaryIdInfos id: IBS-D PAM, type: OTHER, domain: The Akkermansia Company, briefTitle: Study to Assess Effects of Pasteurized Akkermansia Muciniphila vs Placebo in Participants With Diarrhea-predominant IBS, acronym: PAM-DIGEST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-05-01, completionDateStruct date: 2025-05-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: A-Mansia Biotech S.A., class: INDUSTRY, collaborators name: Vedic Lifesciences Pvt. Ltd., descriptionModule briefSummary: The present study is a randomized, double-blind, placebo-controlled, parallel group clinical study that assesses the effect of pasteurized Akkermansia muciniphila on the complaints of subjects with moderate to severe diarrhoea-predominant irritable bowel syndrome (IBS-D). The trial is also evaluating the potential of pAkk on anxiety, low mood and stress of the participants, as well as its safety and tolerability.The intervention duration for all the study participants is 12 weeks (intervention phase). Subsequently, the participants will be invited to return to site for an end of study assessment after 21 days of no intervention (post-intervention phase)., conditionsModule conditions: Diarrhea-Predominant Irritable Bowel Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, Double-blind, Placebo-controlled, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 380, type: ESTIMATED, armsInterventionsModule interventions name: Pasteurized Akkermansia muciniphila (pAKK), interventions name: Placebo, outcomesModule primaryOutcomes measure: To assess the impact of Investigational Product relative to placebo on percentage responders in terms of improvement of the IBS-Symptom Severity Scores (SSS) in participants with moderate to severe diarrhea-predominant irritable bowel syndrome., secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the IBS-SSS from baseline at week 8, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Generalized Anxiety Disorder (GAD)-7 score, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the GAD-7 from baseline at week 12., secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Patient Health Questionnaire (PHQ)-9 score, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on the percentage of participants who are responders in terms of improvement of the PHQ-9 from baseline at week 12., secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Perceived Stress Scale (PSS), secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in Bristol Stool Form Score (BSFS), secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on occurrence of normal BSFS score at the end of the study, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on the quality of life as assessed by the mean change in IBS-QOL scores, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on mean change in IBS-SSS value, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on compliance with the intake of the investigational product, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on Safety and tolerance, secondaryOutcomes measure: To assess the impact of the Investigational Product in comparison to placebo on the impact of IBS on their quality of life using the IBS-Quality of Life (IBS-QoL) instrument., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: HCG Hospital, city: Ahmedabad, state: Gujarat, zip: 380006, country: India, contacts name: Dr. Manoj Vithalani, MBBS, MD, role: CONTACT, phone: 9825024355, email: drmvithalani@gmail.com, contacts name: Dr. Manoj Vithalani, MBBS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.02579, lon: 72.58727, locations facility: Anand Multispeciality Hospital, city: Vadodara, state: Gujarat, zip: 390016, country: India, contacts name: Dr. Himanshu Patel, MBBS, DNB, role: CONTACT, phone: 8141001672, email: dr.himanshuvpatel@gmail.com, contacts name: Dr. Himanshu Patel, MBBS, DNB, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.29941, lon: 73.20812, locations facility: Stress Test Clinic, city: Mumbai, state: Maharashtra, zip: 400059, country: India, contacts name: Dr. Ramesh Dargad, MBBS, MD, role: CONTACT, phone: 9820152828, email: rohitdargad@outlook.com, contacts name: Dr. Ramesh Dargad, MBBS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.07283, lon: 72.88261, locations facility: Criticare Asia Multispeciality Hospital & Research Centre, city: Mumbai, state: Maharashtra, zip: 400069, country: India, contacts name: Dr. Sanjeev Khanna, MD, MNAMS, role: CONTACT, phone: 9820055090, email: dr.sanjeevkhanna@yahoo.com, contacts name: Dr. Sanjeev Khanna, MD, MNAMS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.07283, lon: 72.88261, locations facility: Surya Multispeciality Hospital, city: Nashik, state: Maharashtra, zip: 422003, country: India, contacts name: Dr. Gaurav Bachhav, MD, DM, role: CONTACT, phone: 9867111119, email: drgauravbachhav@gmail.com, contacts name: Dr. Gaurav Bachhav, MD, DM, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.99727, lon: 73.79096, locations facility: Astha Clinic, city: Nashik, state: Maharashtra, zip: 422011, country: India, contacts name: Dr. Mohit Chaudhary, MBBS, MD, role: CONTACT, phone: 7744825746, email: m.chaudhary8@gmail.com, contacts name: Dr. Mohit Chaudhary, MBBS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.99727, lon: 73.79096, locations facility: Apollo Hospital, city: Navi Mumbai, state: Maharashtra, zip: 400614, country: India, contacts name: Dr. Amey Sonavane, MBBS, DNB, role: CONTACT, phone: 9619879955, email: amey_max@yahoo.com, contacts name: Dr. Amey Sonavane, MBBS, DNB, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.03681, lon: 73.01582, locations facility: Swara Hospital, city: Palghar, state: Maharashtra, zip: 401303, country: India, contacts name: Dr. Prashant Walke, MBBS, MD, role: CONTACT, phone: 9860844434, email: walkedrprashant@gmail.com, contacts name: Dr. Prashant Walke, MBBS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.69693, lon: 72.76543, locations facility: Gastrohub Hospital, city: Pune, state: Maharashtra, zip: 411027, country: India, contacts name: Dr. Mandar Doiphode, MBBS, DNB, role: CONTACT, phone: 9850077168, email: mandardoiphode22@gmail.com, contacts name: Dr. Mandar Doiphode, MBBS, DNB, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.51957, lon: 73.85535, locations facility: Umarji Mother and Child Care Hospital, city: Pune, state: Maharashtra, zip: 411045, country: India, contacts name: Dr. Prasad Bhatte, MD DM, role: CONTACT, phone: 9920039265, email: prasadbhate07@gmail.com, contacts name: Dr. Prasad Bhatte, MD DM, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.51957, lon: 73.85535, locations facility: Lifeline Multispeciality Hospita, city: Pune, state: Maharashtra, zip: 412101, country: India, contacts name: Dr. Shrikant Kote, MBBS, MD, role: CONTACT, phone: 7506360679, email: shri.kote86@gmail.com, contacts name: Dr. Shrikant Kote, MBBS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.51957, lon: 73.85535, locations facility: Asian Institute of Medical sciences, city: Thāne, state: Maharashtra, zip: 421203, country: India, contacts name: Dr Vineet Chaudhari, MD, DNB, role: CONTACT, phone: 7337422597, email: chaudhari.vineet@gmail.com, contacts name: Dr Vineet Chaudhari, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.19704, lon: 72.96355, locations facility: Maharaja Agrasen Superspeciality Hospital, city: Jaipur, state: Rajasthan, zip: 302039, country: India, contacts name: Dr. Prabhat K Sharma, MBBS, MD, role: CONTACT, phone: 9983995050, email: pksharma.clinical@gmail.com, contacts name: Dr. Prabhat K Sharma, MBBS, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.91962, lon: 75.78781, locations facility: Samvedna Hospita, city: Varanasi, state: Uttar Pradesh, zip: 221005, country: India, contacts name: Dr. Hemant K Gupta, MBBS, MD, DM, role: CONTACT, phone: 8573888800, email: drhemantg26@gmail.com, contacts name: Dr. Hemant K Gupta, MBBS, MD, DM, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.31668, lon: 83.01041, hasResults: False