{"id":"lactobacillus-fermentum","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disturbance (bloating, gas)"},{"rate":null,"effect":"Mild abdominal discomfort"}]},"_chembl":{"chemblId":"CHEMBL2109070","moleculeType":"Unknown"},"_dailymed":{"setId":"86c9c1a9-452b-4bae-a13e-723e4fc87eef","title":"TERRAMED JUST THINK COMFORT GYNOCARE PROBIOTICS FOR VAGINAL USE (OLEUROPEIN,HYDRASTIS CANADENSIS,BORAX,CALENDULA OFFICINALIS,LACTOBACILLUS FERMENTUM) OINTMENT [RIDA LLC]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a live biotherapeutic, L. fermentum colonizes the gastrointestinal tract, producing short-chain fatty acids and other metabolites that strengthen the intestinal epithelial barrier, reduce pathogenic bacterial overgrowth, and promote balanced immune responses. It may enhance mucosal IgA production and reduce systemic inflammation through microbiota-mediated mechanisms.","oneSentence":"Lactobacillus fermentum is a probiotic bacterium that modulates the gut microbiota and supports intestinal barrier function and immune homeostasis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T02:41:14.844Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Gastrointestinal health and microbiota support"},{"name":"Immune function support"}]},"trialDetails":[{"nctId":"NCT07471659","phase":"NA","title":"Effect of Daily Humiome® Post LB Intake on Wellbeing in Older Individuals With Moderate Stress Levels","status":"NOT_YET_RECRUITING","sponsor":"dsm-firmenich Switzerland AG","startDate":"2026-03-01","conditions":"Stress","enrollment":200},{"nctId":"NCT06937814","phase":"NA","title":"The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers","status":"RECRUITING","sponsor":"dsm-firmenich Switzerland AG","startDate":"2025-06-16","conditions":"GI Issues, Bowel Movements, Gastrointestinal Symptoms","enrollment":250},{"nctId":"NCT07002489","phase":"NA","title":"Efficacy of Notrande Shuhuajun Probiotic Supplement on Lmproving Constipation in Preschool Children","status":"COMPLETED","sponsor":"Shandong Sibote Biotechnology Co., Ltd.","startDate":"2025-05-30","conditions":"Functional Constipation (FC)","enrollment":102},{"nctId":"NCT05433857","phase":"PHASE2","title":"Probiotics in Systemic Lupus Erythematosus","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2022-06-10","conditions":"Systemic Lupus Erythematosus","enrollment":40},{"nctId":"NCT06486064","phase":"NA","title":"Evaluating the Potential of Probiotic Supplementation Sleep Quality","status":"COMPLETED","sponsor":"Chi-Chang Huang","startDate":"2024-08-01","conditions":"Sleep Disorder, Anxiety, Depression","enrollment":84},{"nctId":"NCT07031596","phase":"NA","title":"Study on the Weight Loss Effects and Mechanisms of Probiotic Preparation Intervention in Weight Cyclers","status":"NOT_YET_RECRUITING","sponsor":"Peking Union Medical College Hospital","startDate":"2025-06","conditions":"Obesity and Obesity-related Medical Conditions","enrollment":198},{"nctId":"NCT03773003","phase":"NA","title":"Research for Pathophysiology of Cancer Related Fatigue (CRF) and Chronic Fatigue (CFS/ME)","status":"RECRUITING","sponsor":"Universität des Saarlandes","startDate":"2021-07-20","conditions":"Cancer Related Fatigue, Fatigue Syndrome, Chronic","enrollment":150},{"nctId":"NCT06722443","phase":"NA","title":"Impact of Nutritional Intervention With Probiotics and Prebiotics on Obesity.","status":"ENROLLING_BY_INVITATION","sponsor":"Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental","startDate":"2024-02-01","conditions":"Obesity and Overweight, Obesity, Morbid, Metabolic Syndrome","enrollment":230},{"nctId":"NCT06873425","phase":"NA","title":"Research on the Improvement of Intestinal and Immune Functions by Probiotics","status":"NOT_YET_RECRUITING","sponsor":"Wecare Probiotics Co., Ltd.","startDate":"2025-03-10","conditions":"Intestinal Health","enrollment":40},{"nctId":"NCT04032899","phase":"NA","title":"Effect of Probiotics Consumed During Pregnancy on the Incidence of Mastitis","status":"COMPLETED","sponsor":"Biosearch S.A.","startDate":"2019-04-15","conditions":"Mastitis, Breast Milk, Lactation","enrollment":480},{"nctId":"NCT05917314","phase":"NA","title":"A Study to Evaluate the Effect of SlimBiotics Probiotic Formula on Weight Management and Metabolic Health Outcomes","status":"COMPLETED","sponsor":"Slimbiotics","startDate":"2023-07-01","conditions":"Metabolic Health, Weight Loss, Stress","enrollment":120},{"nctId":"NCT06565312","phase":"NA","title":"A Single Group Study to Evaluate the Effects of a Probiotic Vaginal Suppository on Vaginal Health.","status":"COMPLETED","sponsor":"Love Wellness","startDate":"2024-05-10","conditions":"Vaginal Health, Vaginal pH","enrollment":40},{"nctId":"NCT05864716","phase":"NA","title":"Colonoscopic Probiotics Spray in Irritable Bowel Syndrome","status":"NOT_YET_RECRUITING","sponsor":"National Cheng-Kung University Hospital","startDate":"2024-10-01","conditions":"Effect of Drug","enrollment":66},{"nctId":"NCT06501404","phase":"NA","title":"PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis","status":"COMPLETED","sponsor":"José Antonio Hurtado Suazo","startDate":"2015-01-10","conditions":"Premature Infants, Necrotizing Enterocolitis","enrollment":583},{"nctId":"NCT05735418","phase":"NA","title":"The Effect of GI Biome #7 on Gut Microbiome and Health of the Elderly","status":"COMPLETED","sponsor":"Seoul National University Hospital","startDate":"2023-01-13","conditions":"Muscle Weakness","enrollment":60},{"nctId":"NCT06361368","phase":"NA","title":"Efficacy Assessment of Probiotics in Improving Sleep Indices","status":"RECRUITING","sponsor":"National Yang Ming Chiao Tung University","startDate":"2024-04-11","conditions":"Insomnia","enrollment":140},{"nctId":"NCT06183801","phase":"NA","title":"Effects of Probiotics on Metabolic Syndrome ,Intestinal Microflora and SCFA.","status":"COMPLETED","sponsor":"Glac Biotech Co., Ltd","startDate":"2021-08-01","conditions":"Metabolic Syndrome","enrollment":82},{"nctId":"NCT05943925","phase":"","title":"Dementias and Microbiota Composition: Is Possible to Revert the Dementia Symptoms Reverting the Microbiota Composition?","status":"UNKNOWN","sponsor":"University Rovira i Virgili","startDate":"2021-04-16","conditions":"Dementia Alzheimers, Dementia With Lewy Bodies, Parkinson Disease Dementia","enrollment":240},{"nctId":"NCT05527301","phase":"PHASE2","title":"HEM1036 Phase 2 Study in Low Anterior Resection Syndrome","status":"UNKNOWN","sponsor":"HEM Pharma Inc.","startDate":"2024-01-01","conditions":"LARS - Low Anterior Resection Syndrome","enrollment":67},{"nctId":"NCT04053790","phase":"PHASE4","title":"Lactobacillus LB as Treatment for Irritable Bowel Syndrome With Predominance of Diarrhea (IBS-D)","status":"COMPLETED","sponsor":"Hospital General de Mexico","startDate":"2019-01-15","conditions":"Irritable Bowel Syndrome With Diarrhea","enrollment":177},{"nctId":"NCT05467605","phase":"NA","title":"Effect of Probiotics on Cytokines in Sepsis in Children","status":"COMPLETED","sponsor":"Cairo University","startDate":"2022-07-22","conditions":"Sepsis, Severe","enrollment":80},{"nctId":"NCT04167995","phase":"EARLY_PHASE1","title":"Assessment of Probiotics Lactobacillus in the Management of Attention Deficit Hyperactive Disorder","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2020-06-09","conditions":"Inattentive, Hyperactivity, Impulsivity","enrollment":80},{"nctId":"NCT04293666","phase":"NA","title":"Functional Evaluation of Kefir Drink on Antifatigue and Exercise Exercise Performance-2","status":"COMPLETED","sponsor":"National Taiwan Sport University","startDate":"2019-01-27","conditions":"Exercise Performance, Fatigue","enrollment":32},{"nctId":"NCT05076656","phase":"EARLY_PHASE1","title":"Epigenetic and Microbiota Modifications","status":"COMPLETED","sponsor":"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud","startDate":"2019-06-10","conditions":"Diabetes type2, Obesity","enrollment":22},{"nctId":"NCT05405205","phase":"NA","title":"Effect of Synbiotic L. Fermentum Strains on Body Fat Mass","status":"UNKNOWN","sponsor":"Slimbiotics GmbH","startDate":"2021-06-08","conditions":"Weight, Body","enrollment":180},{"nctId":"NCT04754464","phase":"NA","title":"Clinical Study on the Effect of a Synbiotic on Body Fat Mass","status":"COMPLETED","sponsor":"Slimbiotics GmbH","startDate":"2020-05-13","conditions":"Type 2 Diabetes, Metabolic Syndrome, Obesity, Abdominal","enrollment":120},{"nctId":"NCT05343533","phase":"NA","title":"Probiotic Administration on Mood","status":"COMPLETED","sponsor":"Lindenwood University","startDate":"2019-07-17","conditions":"Depression, Sleep, Stress","enrollment":70},{"nctId":"NCT05283278","phase":"PHASE1","title":"Effect of Administration of Combined Enteral Lactoferrin and Probiotic On Invasive Fungal Infections In Preterm Neonates","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2020-02-10","conditions":"Fungal Infection","enrollment":80},{"nctId":"NCT03940612","phase":"NA","title":"Probiotic for Vaginal Candidiasis in Pregnant Women","status":"COMPLETED","sponsor":"Universiti Sains Malaysia","startDate":"2019-06-16","conditions":"Vaginal Diseases","enrollment":80},{"nctId":"NCT03923985","phase":"NA","title":"Clinical Trial to Evaluate the Effect of an Oral Probiotic on the Vaginal Flora","status":"COMPLETED","sponsor":"Instituto Palacios","startDate":"2019-03-21","conditions":"Vaginal Flora","enrollment":40},{"nctId":"NCT04572932","phase":"NA","title":"Probiotics and Irritable Bowel Syndrome","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2019-05-01","conditions":"Irritable Bowel Syndrome","enrollment":90},{"nctId":"NCT03467334","phase":"PHASE2","title":"Infant Colic Treatment With Probiotics","status":"COMPLETED","sponsor":"Mónica Olivares Martín; PhD","startDate":"2017-05-31","conditions":"Infant Colic","enrollment":156},{"nctId":"NCT03539263","phase":"NA","title":"Effects of Probiotics on Mood","status":"COMPLETED","sponsor":"Probiotical S.p.A.","startDate":"2016-12-20","conditions":"Depression, Anxiety","enrollment":39},{"nctId":"NCT03204630","phase":"NA","title":"Functional Evaluation of Two Infant Formula Supplemented With Probiotics Isolated From Breast Milk","status":"COMPLETED","sponsor":"Biosearch S.A.","startDate":"2011-01","conditions":"Infant Nutrition","enrollment":236},{"nctId":"NCT03049579","phase":"NA","title":"Immune System Stimulation by Probiotic Food Supplementation","status":"COMPLETED","sponsor":"Hangzhou Wei Chuan Foods Co., Ltd.","startDate":"2016-01-08","conditions":"Flu Symptom","enrollment":136},{"nctId":"NCT02203877","phase":"NA","title":"Evaluation of Lactobacillus Fermentum CECT5716 on the Incidence of Mastitis","status":"COMPLETED","sponsor":"Biosearch S.A.","startDate":"2013-08","conditions":"Mastitis","enrollment":625},{"nctId":"NCT00256022","phase":"NA","title":"The Effect of Prophylactic Pre Operative Probiotic Therapy on Endotoxin Levels in Cardiac Surgery Patients","status":"WITHDRAWN","sponsor":"Melbourne Health","startDate":"2007-07","conditions":"Preoperative Cardiac Surgery Patients","enrollment":""},{"nctId":"NCT01635738","phase":"NA","title":"Probiotics and Allergic Diseases","status":"COMPLETED","sponsor":"GenMont Biotech Incorporation","startDate":"2011-12","conditions":"Atopic Dermatitis, Asthma","enrollment":240},{"nctId":"NCT02093338","phase":"NA","title":"L.Fermentum CECT5716 in Treatment of Breast Pain","status":"COMPLETED","sponsor":"Biosearch S.A.","startDate":"2011-07","conditions":"Breast Pain","enrollment":127},{"nctId":"NCT01346644","phase":"NA","title":"Safety of Lactobacillus Fermentum in Newborn Infants","status":"COMPLETED","sponsor":"Puleva Biotech","startDate":"2009-02","conditions":"Tolerance","enrollment":137},{"nctId":"NCT01215656","phase":"PHASE2, PHASE3","title":"Effect of a Follow on Formula With Lactobacillus Fermentum on the Incidence of Infections","status":"COMPLETED","sponsor":"Puleva Biotech","startDate":"2008-05","conditions":"Incidence of Infectious Diseases","enrollment":188},{"nctId":"NCT00716183","phase":"PHASE2, PHASE3","title":"Use of Probiotic Lactobacilli for the Treatment of Lactational Mastitis","status":"COMPLETED","sponsor":"Universidad Complutense de Madrid","startDate":"2008-07","conditions":"Mastitis","enrollment":300},{"nctId":"NCT00294788","phase":"PHASE1, PHASE2","title":"Evaluation of the Safety and Effectiveness of a Probiotic Bacterium to Boost the Immune Response to Influenza Vaccines","status":"UNKNOWN","sponsor":"Probiomics Ltd","startDate":"2006-03","conditions":"Influenza","enrollment":300}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"GASTROENTERITIS"},{"count":1,"reaction":"IMMUNODEFICIENCY"},{"count":1,"reaction":"INTESTINAL OBSTRUCTION"},{"count":1,"reaction":"MENINGITIS"},{"count":1,"reaction":"NEUTROPENIA"},{"count":1,"reaction":"OFF LABEL USE"},{"count":1,"reaction":"PNEUMONIA"},{"count":1,"reaction":"VOMITING"}],"_approvalHistory":[],"publicationCount":1558,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["HEM1036"],"phase":"marketed","status":"active","brandName":"Lactobacillus Fermentum","genericName":"Lactobacillus Fermentum","companyName":"HEM Pharma Inc.","companyId":"hem-pharma-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Lactobacillus fermentum is a probiotic bacterium that modulates the gut microbiota and supports intestinal barrier function and immune homeostasis. Used for Gastrointestinal health and microbiota support, Immune function support.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}