Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis (HBOT-pouch)
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|ClinicalTrials.gov Identifier: NCT03526796|
Recruitment Status : Unknown
Verified May 2018 by Jianfeng Gong, Jinling Hospital, China.
Recruitment status was: Not yet recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pouchitis Hyperbaric Oxygen Therapy||Procedure: Hyperbaric oxygen therapy||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis: a Phase 2A Clinical Trial|
|Estimated Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Hyperbaric oxygen therapy
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 [ Time Frame: up to 4 weeks ]Defined by a pouchitis disease activity index (PDAI) score of < 7 points
- Response rate [ Time Frame: up to 4 weeks ]Defined as a ≥ 3-point reduction in the 18-point PDAI scoring system
- Symptomatic improvement rate [ Time Frame: up to 4 weeks ]Reduction of PDAI clinical subscore >2 points.
- Endoscopic improvement rate [ Time Frame: up to 4 weeks ]Reduction of PDAI endoscopic subscore >2 points.
- Fecal calprotectin level [ Time Frame: up to 4 weeks ]Fecal caprotectin level before and after treatment
- Plasma C-reactive protein level [ Time Frame: up to 4 weeks ]Plasma caprotectin level before and after treatment
- Plasma Interleukin-6 level [ Time Frame: up to 4 weeks ]Plasma Interleukin-6 level before and after treatment
- Fecal microbiome [ Time Frame: up to 4 weeks ]Fecal microbiome analysis using 16S RNA technique before and after treatment
- Adverse events [ Time Frame: up to 4 weeks ]Any adverse event deemed as possibly, probably, or definitely related to investigational treatment during 2-3 weeks of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526796
|Contact: Jianfeng Gong, MDfirstname.lastname@example.org|
|Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University|
|Nanjing, Jiangsu, China, 210000|
|Principal Investigator:||Jianfeng Gong, MD||Jinling Hospital, China|