Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis

Pouchitis Clinical Trial

— HBOT-pouch  

Official title:

Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis: a Phase 2A Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03526796
• Other study ID #: HBOT-pouchitis
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 2020

Study information

• Verified date: May 2018
• Source: Jinling Hospital, China
• Contact: Jianfeng Gong, MD
• Phone: +86-25-80860036
• Email: gongjianfeng[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of current study is to evaluate the effect of hyperbaric oxygen therapy for the treatment of chronic antibiotic-refractory pouchitis.

Description:

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: July 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• IPAA performed for ulcerative colitis;

• Pouchitis Disease Activity Index (PDAI) scores =7;

• Antibiotic refractory pouchitis(CARP), defined as patients who do not respond to conventional 2-week, single-agent antibiotic therapy including metronidazole,ornidazole,tinidazole, or ciprofloxacin

• 18-75years

• Informed consent given

• Able and willing to comply with all trial procedures

• Including prepouch ileitis

Exclusion Criteria:

• Crohn's disease of the pouch

• Pouchitis after IPAA for FAP

• Isolated cuffitis

• with cocomttant Primary sclerosing cholangitis (PSC)

• Pouch strictures

• Abscess/Sinuses

• Perianal disease

• Active malignancy

• Uncontrolled systemic diseases

• History of noninfammatory disease of the pouch

• Decreased pouch compliance

• Irritable pouch syndrome

• Afferent or efferent limb obstruction

• Needing oral or topical steroid or 5-ASA

• Major physical or psychiatric illness within the last 6m

• Active use of cholestyramine, NSAIDs or aspirin

• Pregnant, breast feeding

• Clinically significant co-morbidities causing untolerant or unsuitable for hyperbaric oxygen therapy.

Related Conditions & MeSH terms

• Hyperbaric Oxygen Therapy
• Pouchitis

Intervention

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.

Locations

Country	Name	City	State
China	Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate	Defined by a pouchitis disease activity index (PDAI) score of < 7 points	up to 4 weeks
Secondary	Response rate	Defined as a = 3-point reduction in the 18-point PDAI scoring system	up to 4 weeks
Secondary	Symptomatic improvement rate	Reduction of PDAI clinical subscore >2 points.	up to 4 weeks
Secondary	Endoscopic improvement rate	Reduction of PDAI endoscopic subscore >2 points.	up to 4 weeks
Secondary	Fecal calprotectin level	Fecal caprotectin level before and after treatment	up to 4 weeks
Secondary	Plasma C-reactive protein level	Plasma caprotectin level before and after treatment	up to 4 weeks
Secondary	Plasma Interleukin-6 level	Plasma Interleukin-6 level before and after treatment	up to 4 weeks
Secondary	Fecal microbiome	Fecal microbiome analysis using 16S RNA technique before and after treatment	up to 4 weeks
Secondary	Adverse events	Any adverse event deemed as possibly, probably, or definitely related to investigational treatment during 2-3 weeks of treatment.	up to 4 weeks