[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647991":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":25,"responsibleParty":40,"collaborators":42,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":25,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":76,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":25},{"fullName":5,"class":6},"Gala Servicios Clinicos S.L.","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enzymax DuoBiotics","EXPERIMENTAL","Participants assigned to this arm will receive one capsule of Enzymax DuoBiotics orally once daily for 12 weeks. Enzymax DuoBiotics contains digestive enzymes, Lactobacillus plantarum, and fructooligosaccharides in a capsule-in-capsule delivery system.",[13],"Dietary Supplement: Enzymax DuoBiotics",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants assigned to this arm will receive one placebo capsule orally once daily for 12 weeks. The placebo will be administered according to the same dosing schedule as Enzymax DuoBiotics.",[19],"Dietary Supplement: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Participants will receive one capsule of Enzymax DuoBiotics orally once daily for 12 weeks. Each capsule uses a capsule-in-capsule delivery system. The outer capsule, intended for release in the stomach, contains lipase (4,000 FIP), protease 4.5 (3,120 HUT), protease 3.0 (15 SAPU), amylase (2,150 DU), and glucoamylase (14 AGU). The inner capsule, intended for release in the intestine, contains Lactobacillus plantarum (5 × 10⁹ CFU) and fructooligosaccharides (140 mg).",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Participants will receive one placebo capsule orally once daily for 12 weeks, according to the same administration schedule as the active dietary supplement.",[15],[30],{"name":31,"affiliation":32,"role":33},"Sergio Chamorro Benítez, MD","Hospital Parque Vegas Altas, Don Benito (Badajoz)","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Alberto Yedro","CONTACT","+34647725527","gestion@galaserviciosclinicos.es",{"type":41,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[43],{"name":44,"class":6},"University of Extremadura","100647991","enzymax-duobiotics-for-irritable-bowel-syndrome-100647991",false,"NCT07716852","Enzymax DuoBiotics for Irritable Bowel Syndrome","A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Efficacy and Safety of Enzymax DuoBiotics in Adults With Irritable Bowel Syndrome","ENZYMAX-IBS","Inclusion Criteria:\n\n* Adults aged 18 to 70 years\n* Diagnosis of irritable bowel syndrome according to the Rome IV criteria.\n* Presence of active irritable bowel syndrome symptoms at the time of enrollment.\n* Ability and willingness to provide written informed consent.\n* Ability and willingness to comply with the study procedures and the 12-week treatment period.\n\nExclusion Criteria:\n\n* Presence of an organic gastrointestinal disease.\n* Use of antibiotics or probiotics within 1 month before enrollment.\n* Recent clinically relevant changes in diet.\n* Severe comorbid medical conditions.\n* Inability or unwillingness to comply with the study protocol.\n* Known hypersensitivity to any component of Enzymax DuoBiotics or to dietary supplements of similar composition.\n* Any other condition that, in the investigator's judgment, may interfere with participation, study treatment, or interpretation of the results.","ALL","18 Years","70 Years",{"count":57,"type":58},120,"ESTIMATED","INTERVENTIONAL",[61],"NA","Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by recurrent abdominal pain associated with altered bowel habits in the absence of detectable structural abnormalities. Its pathophysiology is multifactorial and may involve alterations in the intestinal microbiota, impaired epithelial barrier function, low-grade immune activation, and disturbances in the digestion and fermentation of dietary nutrients.\n\nEnzymax DuoBiotics combines digestive enzymes with a synbiotic formulation in a capsule-in-capsule delivery system. The outer capsule contains digestive enzymes intended for release in the stomach, whereas the inner capsule contains Lactobacillus plantarum and fructooligosaccharides intended for release in the intestine. This formulation is designed to separate the enzymatic and synbiotic components and support their delivery to the intended gastrointestinal sites. The combined approach is intended to support macronutrient digestion while modulating the intestinal microbial environment.\n\nThis randomized, double-blind, placebo-controlled, parallel-group study will compare once-daily Enzymax DuoBiotics with placebo over a 12-week treatment period in adults with IBS. Participants will be allocated in a 1:1 ratio, and treatment effects over time will be evaluated using assessments performed during the treatment period. The primary statistical analysis will use linear mixed-effects models including treatment group, time, and the treatment group-by-time interaction. The primary analysis will follow the intention-to-treat principle and may be supplemented by a per-protocol analysis.",[64,65],"Irritable Bowel Syndrome","Irritable Bowel Syndrome (IBS)",[67,68,9,69,70,71,72,73,74,75],"Irritable bowel syndrome","IBS","Dietary supplement","Synbiotic","Lactobacillus plantarum","Fructooligosaccharides","Digestive enzymes","Gastrointestinal symptoms","Gut microbiota","NOT_YET_RECRUITING","2026-07-22",{"date":79,"type":80},"2026-07-23","ACTUAL",{"date":82,"type":58},"2026-09-30",{"date":84,"type":58},"2027-09-30",{"name":5,"class":6}]