[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639705":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":42,"studyPopulation":31,"armGroups":43,"interventions":56,"overallOfficials":31,"centralContacts":65,"locations":71,"responsibleParty":89,"collaborators":31,"id":93,"slug":31,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":31,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":31,"enrollmentInfo":101,"targetDuration":31,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":74,"whyStopped":31,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"The Second Hospital of Nanjing Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":31},[9],{"measure":10,"description":11,"timeFrame":12},"The changes of core-symptom score in patients with ischemic-hypoxic bowel disease after intervention.","The severity of core symptoms (including abdominal pain, abdominal distention, and difficult defecation) was assessed using the VAS score, which ranged from 0 to 10 for each symptom, with higher scores indicating more severe symptoms, and the total score ranged from 0 to 30.","Five-day after intervention",[14,17,20,24,28],{"measure":15,"description":16,"timeFrame":12},"Overall patient satisfaction with intervention.","The patients' satisfaction with the treatment was graded into five levels: very dissatisfied, dissatisfied, average, relatively satisfied, and very satisfied. The differences of treatment satisfaction among different groups were compared.",{"measure":18,"description":19,"timeFrame":12},"The incidence rate of adverse events","The number of adverse reactions reported by subjects from the start of treatment to the end of follow-up",{"measure":21,"description":22,"timeFrame":23},"Change in intestinal movement frequency","The movement frequency of the large intestine (ascending colon, transverse colon, and descending colon) is detected using an intestinal motility detector. The change in movement frequency between the two groups will be compared.","Baseline and 30 minutes after the last intervention on day 5",{"measure":25,"description":26,"timeFrame":27},"Change in intestinal movement amplitude","The movement amplitude of the large intestine (ascending colon, transverse colon, and descending colon) is detected using an intestinal motility detector. The change in movement amplitude between the two groups will be compared.","Baseline and 30 minutes after the last intervention on day 5.",{"measure":29,"description":30,"timeFrame":12},"The changes in gut microbiota composition and metabolites before and after treatment.","The 16s-RNA or meta-analysis of gut microbiota will be used.",null,{"allocation":33,"interventionModel":34,"interventionModelDescription":31,"primaryPurpose":35,"observationalModel":31,"timePerspective":31,"maskingInfo":36},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":37,"maskingDescription":31,"whoMasked":38},"TRIPLE",[39,40,41],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Subjects who met the inclusion criteria but did not meet any of the exclusion criteria were randomly assigned in a 1:1 ratio to receive 250mL of oxygen (30%-40%) or air through a deep intestinal catheterization four times a day for 5 days. The data of core symptoms (abdominal pain, abdominal distension, defecation), intestinal motility, vital signs and test results before and after treatment were collected to evaluate the efficacy and safety of gut oxygen therapy.",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"Treatment","EXPERIMENTAL","Participants will receive 250mL of oxygen (30%) through a deep intestinal catheterization four times a day for 5 days",[49],"Other: Oxygen 30 %",{"label":51,"type":52,"description":53,"interventionNames":54},"Control","PLACEBO_COMPARATOR","Participants will receive 250mL of air through a deep intestinal catheterization four times a day for 5 days.",[55],"Other: Air",[57,61],{"type":6,"name":58,"description":59,"armGroupLabels":60,"otherNames":31},"Oxygen 30 %","Patients will receive 250mL of oxygen (30%) through a deep intestinal catheterization four times a day for 5 days.",[45],{"type":6,"name":62,"description":63,"armGroupLabels":64,"otherNames":31},"Air","Patients will receive 250mL of air through a deep intestinal catheterization four times a day for 5 days.",[51],[66],{"name":67,"role":68,"phone":69,"phoneExt":31,"email":70},"Faming Zhang, PhD","CONTACT","086-25-58509883","fzhang@njmu.edu.cn",[72],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"The Second Affiliated Hospital of Nanjing Medical University","RECRUITING","Nanjing","Jiangsu","210011","China","CN",{"type":81,"coordinates":82},"Point",[83,84],118.77778,32.06167,{"lat":84,"lon":83},[87],{"name":88,"role":68,"phone":69,"phoneExt":31,"email":70},"Faming Zhang, Professor",{"type":90,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Faming Zhang","Professor","100639705",false,"NCT07621367","Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease","Efficacy and Safety of Gut Oxygen Therapy for Ischemic-Hypoxic Bowel Disease: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study","Inclusion Criteria:\n\n* Clinical diagnosis of intestinal ischemia and hypoxia-related diseases caused by conditions such as ischemic bowel disease, heart failure, etc., presenting with recurrent or persistent abdominal pain and\u002For distension, and difficulty in defecation. Examples include: heart failure-related defecation difficulty, severe malnutrition combined with defecation difficulty, acute ischemic bowel disease, and chronic ischemic bowel disease.\n* At least able to perform bedside activities and able to defecate in conventional positions (sitting or squatting).\n* Age ≥18 years, and able to voluntarily sign informed consent.\n\nExclusion Criteria:\n\n* Acute intestinal emergencies such as acute intestinal obstruction, intestinal perforation, or active massive gastrointestinal bleeding.\n* Intestinal fistula.\n* History of abdominal surgery within the recent past (\\\u003C1 month).\n* Severe uncontrolled arrhythmia or respiratory failure.\n* Cardiac function Class IV (NYHA Class IV).\n* Patients with abnormal visceral pressure sensitivity.\n* Inability to cooperate with study assessments.\n* Other conditions that, in the opinion of the investigator, make the subject unsuitable for inclusion.","ALL","18 Years",{"count":102,"type":103},90,"ESTIMATED","INTERVENTIONAL",[106],"NA","This multicenter, randomized, double-blind, placebo-controlled clinical trial aimed to investigate the efficacy and safety of gut oxygen therapy in the treatment of ischemic-hypoxic bowel disease using deep intestinal catheterization as a targeted route for gut oxygen delivery.",[109,110],"Ischemic Bowel Disease","Hypoxic Events",[112,113,114,115,116],"ischemic bowel disease","heart failure","abdominal pain","abdominal distension","difficult defecation","2026-06-01",{"date":119,"type":120},"2026-06-02","ACTUAL",{"date":122,"type":103},"2026-05-28",{"date":124,"type":103},"2031-05-19",{"name":5,"class":6},1]