[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566303":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":53,"collaborators":20,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":20,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":20,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Northwestern University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sodium butyrate (NaBu)","EXPERIMENTAL","Participants in the study will be administered Sodium Butyrate (NaBu) in tablet form. Each participant will take a dosage of 2.4 grams, which equates to two tablets, once daily. This regimen will be maintained for a duration of 12 weeks. The supplement is self-administered, and participants are required to record their daily symptom severity in an electronic diary (eDiary) throughout the study period. This intervention aims to assess the effectiveness of NaBu in reducing menstrual symptoms by comparing the average symptom scores during the 12-week treatment period to the baseline scores recorded before starting the supplement.",[13],"Dietary Supplement: Sodium Butyrate (NaBu)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DIETARY_SUPPLEMENT","Sodium Butyrate (NaBu)","Participants will self-administer Sodium Butyrate (NaBu) daily for 12 weeks. The study aims to evaluate the effect of NaBu on menstrual symptoms by comparing symptom severity before and during the intervention. Participants will maintain an electronic diary (eDiary) to record their daily symptom severity, which will be used to assess changes over time. Regular follow-ups will be conducted to monitor progress and address any side effects or concerns.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Magdy P Milad, MD MS","Northwestern Medicine","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"juan A avitia, MS","CONTACT","312-694-6447","juan.avitia1@nm.org",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Northwestern University - Northwestern Medicine, Lavin Family Pavilion","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-87.65005,41.85003,{"lat":45,"lon":44},[48,50],{"name":23,"role":29,"phone":30,"phoneExt":20,"email":49},"mmilad@nm.org",{"name":51,"role":29,"phone":52,"phoneExt":20,"email":31},"Juan A Avitia, MB BCh BAO MPH","312-926-0757",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Magdy Milad, MD","Division Chief, MIGS; Medical Director, Center for Complex Gynecology","100566303","the-nabu-effect-on-menstruation-in-women-100566303",false,"NCT06653426","The NaBu Effect on Menstruation in Women","The Effect of Sodium Butyrate on Menstrual Symptoms in Women","Inclusion Criteria:\n\n* 18 years or older.\n* Menstruating regularly or irregularly\n* Experiencing menstrual symptoms with an average baseline symptom score of at least 3 on a scale of 0 to 10 for at least one symptom during the initial pre-study rating period.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding patient, attempting or anticipating pregnancy.\n* Patient with a history of bloating or a sensitive gut (food intolerance) who needs lower fiber levels.\n* Patients with known lactose intolerance, other fermentable oligo-, di-, and mono-saccharides, and polyols (FODMAP) intolerances, or small intestinal bacterial overgrowth (SIBO).\n* Patients who would require taking daily antacids for the duration of the study.\n* Patients with known or suspected chronic hypertension.\n* Post-menopausal patients","FEMALE","18 Years",{"count":67,"type":68},15,"ESTIMATED","INTERVENTIONAL",[71],"NA","The purpose of this study is to evaluate the effect of once-daily Sodium butyrate (NaBu) on menstrual symptoms in women. The investigators posit that the use of NaBu will reduce menstrual symptoms after taking NaBu for 12 weeks.",[74],"Menstrual Symptoms","2026-04-23",{"date":77,"type":78},"2026-04-29","ACTUAL",{"date":80,"type":78},"2024-10-01",{"date":82,"type":68},"2026-12",{"name":55,"class":6},1]