Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis (HBOT-pouch)

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

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

Study Overview

• Status: Unknown
• Conditions: Pouchitis; Hyperbaric Oxygen Therapy
• Intervention / Treatment: Procedure: Hyperbaric oxygen therapy

Detailed 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).

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission rate	Defined by a pouchitis disease activity index (PDAI) score of < 7 points	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	Defined as a ≥ 3-point reduction in the 18-point PDAI scoring system	up to 4 weeks
Symptomatic improvement rate	Reduction of PDAI clinical subscore >2 points.	up to 4 weeks
Endoscopic improvement rate	Reduction of PDAI endoscopic subscore >2 points.	up to 4 weeks
Fecal calprotectin level	Fecal caprotectin level before and after treatment	up to 4 weeks
Plasma C-reactive protein level	Plasma caprotectin level before and after treatment	up to 4 weeks
Plasma Interleukin-6 level	Plasma Interleukin-6 level before and after treatment	up to 4 weeks
Fecal microbiome	Fecal microbiome analysis using 16S RNA technique before and after treatment	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.	up to 4 weeks

Collaborators and Investigators

• Sponsor: Jinling Hospital, China

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2018
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): July 1, 2020

Study Registration Dates

• First Submitted: April 14, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (ACTUAL): May 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Pouchitis; Hyperbaric oxygen therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Enteritis; Ileitis; Ileal Diseases; Pouchitis
• Other Study ID Numbers: HBOT-pouchitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No