Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares
关键词
抽象
日期
| 最后验证: | 03/31/2020 |
| 首次提交: | 04/03/2018 |
| 提交的预估入学人数: | 04/03/2018 |
| 首次发布: | 04/10/2018 |
| 上次提交的更新: | 04/19/2020 |
| 最近更新发布: | 04/21/2020 |
| 实际学习开始日期: | 09/06/2017 |
| 预计主要完成日期: | 08/31/2020 |
| 预计完成日期: | 08/31/2020 |
状况或疾病
干预/治疗
Other: Hyperbaric Oxygen Therapy
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: 5 Days Hyperbaric Therapy Patients will be enrolled and follow an identical medical treatment algorithm. At day 3 responders (based on partial Mayo score) will be re-randomized in a 1:1 fashion to complete 5 total days of HBOT (1 session per day) or to stop after 3 days of HBOT. Non-responders will be entered into an open label arm to complete 5 total days of HBOT. | |
| Active Comparator: 3 Days Hyperbaric Therapy Patients will be enrolled and follow an identical medical treatment algorithm. At day 3 responders (based on partial Mayo score) will be re-randomized in a 1:1 fashion to complete 5 total days of HBOT (1 session per day) or to stop after 3 days of HBOT. Non-responders will be entered into an open label arm to complete 5 total days of HBOT. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Hospitalized patients with known or newly diagnosed moderate to severe ulcerative colitis (as defined by the Mayo score ≥6) - Consented within the first 48 hours of initiating IV steroids - Risk score of >3 points (pts) - Mean stool frequency/24 hrs (<4 = 0 pts, 4-6 = 1 pt, 7-9 = 2 pts, >9 = 4 pts) - Colonic Dilation = 4pts - Hypoalbuminemia (< 3mg/dL) = 1 pts - Mayo endoscopic sub-score >2 (moderate to severe) - Age >18 and able to make their own medical decisions Exclusion Criteria: - Complication requiring urgent surgical intervention (in the opinion of the investigators) - Clinically significant cardiac, renal, neurological, endocrine, respiratory or hepatic impairment in the opinion of the investigator, including but not limited to: - Pulmonary (COPD with CO2 retention; Previous/current imaging showing hyperinflation/air trapping/bullous disease/blebs (opinion of investigators), Current pneumothorax or previous spontaneous pneumothorax, Bronchogenic cyst(s)) - Cardiac (Uncontrolled HTN (systolic >160 or diastolic >100), Unstable angina or myocardial infarction within the previous 3 months, Ejection fraction < 35%, Current or previous amiodarone use, ICD in place, Pacemaker in place not approved for chamber use) - Hematological/Oncological (Current chemotherapeutic drug use, and past history of bleomycin use,Hereditary Spherocytosis, Sickle cell anemia) - Gastrointestinal and Infectious Disease (Known or suspected Crohn's disease, Previous infection with mycobacterium, fungus, HIV, Hepatitis B or C, Severe gastrointestinal or systemic infection (opinion of investigator), Current capsule endoscopy or previously non-retrieved capsule - Endocrinology (Uncontrolled hyperthyroidism) - Neurological and Psychological (Vagal or other nerve stimulators, Uncontrolled seizure disorder, Medications or medical conditions that lower seizure threshold (opinion of the investigator), Drug or alcohol abuse/dependence,Current treatment for alcohol cessation with disulfiram, Current or recent (within past week) use of baclofen) - Head and Neck (Previous middle ear damage, surgery or infection(s) which may increase the risk for needing ear tubes (opinion of the investigator),Current or previous retinal detachment or optic neuritis, Retinal or vitreous surgery within the past 3 months) - Implanted devices not on the approved list for use with HBOT - Women who are pregnant or nursing. Women with childbearing potential were required to use effective birth control if not surgically sterile or postmenopausal for >2 years. |
结果
主要结果指标
1. Impact of HBOT on clinical response/remission [5 Days]
次要成果指标
1. relative and absolute reduction in the Mayo score [Day 5, 10]
2. Flair duration [day 5, 10]
3. Hospitalization duration [day5, 10]
4. proportion of patients requiring other therapy [Day 5, 10]
5. Relative and absolute change in inflammatory markers [day 10]
6. Relative and absolute change in inflammatory markers [day 10]
7. Relative and absolute change in inflammatory markers [day 10]
8. Relative and absolute change in inflammatory markers [day 10]
9. Relative and absolute change in gene expression [day 10]
10. Relative and absolute change in gene expression [day 10]
11. Relative and absolute change in gene expression [day 10]
12. microbiome composition [day 10]
