An interventional study of Hyperbaric oxygen therapy in Pouchitis and Hyperbaric Oxygen Therapy, sponsored by Jinling Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-05-16.
Sponsored by Jinling Hospital, China · Not applicable, Interventional, and Treatment
The aim of current study is to evaluate the effect of hyperbaric oxygen therapy for the treatment of chronic antibiotic-refractory pouchitis.
Pouch ischemia plays an important role in the pathogenesis of pouchitis after IPAA surgery for ulcerative colitis. Obese Male patients are at high risk for pouchitis because of mesenteric tension. Excessive weight gain is associated with an increased risk for pouch failure in patients with restorative proctocolectomy. Also, patients with an 'S' pouch hardly ever develop chronic pouchitis, owing to the additional length of bowel loop along with mesentery when attached to the anal transitional zone. The treatment of chronic antibiotic-refractory pouchitis(CARP) is difficult.
Hyperbaric oxygen therapy(HBOT) have been proven effecitve in the treatment of inflammatory bowel diseases(IBD). Meta-analysis revealed that the overall response rate was 86% (85% CD, 88% UC), and of the endoscopic response rate to HBOT is 100%. The possible mechanism might be due to the prmoted wound healing by increasing oxygen delivery to hypooxic tissues and changes in inflammatory and immunological mediators.
Therefore, the aim of current study is to examine the therapeutic effect of HBOT for chronic antibiotic-refractory pouchitis(CARP).
50 studies on the registry are indexed under Pouchitis; 12 are open to participants now.
This study's planned enrollment of 20 is close to the median of 20 across 42 interventional studies indexed under Pouchitis.
Browse Pouchitis studies →Jinling Hospital, China is the lead sponsor of 131 studies on the registry; 35 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who recieve hyperbaric oxygen therapy will be maintained at 2.4 ATA with 100% oxygen for 90 min and then decompressed back to 1 ATA. The treatment duration is 4 weeks and extends to 6 weeks if necessary.
Procedure: Hyperbaric oxygen therapy
Patients were maintained at 2.4 ATA with 100% oxygen for 90 min and then decompressed back to 1 ATA. The treatment duration is 4 weeks and extends to 6 weeks if necessary.
Remission rate
Defined by a pouchitis disease activity index (PDAI) score of \< 7 points
Time frame: up to 4 weeks
Response rate
Defined as a ≥ 3-point reduction in the 18-point PDAI scoring system
Time frame: up to 4 weeks
Symptomatic improvement rate
Reduction of PDAI clinical subscore \>2 points.
Time frame: up to 4 weeks
Endoscopic improvement rate
Reduction of PDAI endoscopic subscore \>2 points.
Time frame: up to 4 weeks
Fecal calprotectin level
Fecal caprotectin level before and after treatment
Time frame: up to 4 weeks
Plasma C-reactive protein level
Plasma caprotectin level before and after treatment
Time frame: up to 4 weeks
Plasma Interleukin-6 level
Plasma Interleukin-6 level before and after treatment
Time frame: up to 4 weeks
Fecal microbiome
Fecal microbiome analysis using 16S RNA technique before and after treatment
Time frame: up to 4 weeks
Adverse events
Any adverse event deemed as possibly, probably, or definitely related to investigational treatment during 2-3 weeks of treatment.
Time frame: up to 4 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jun 2018; primary completion for May 2020, 23 months later.
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This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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