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

Primary Purpose

Pouchitis, Hyperbaric Oxygen Therapy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hyperbaric oxygen therapy
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pouchitis focused on measuring Pouchitis, Hyperbaric oxygen therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperbaric oxygen therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Remission rate
Defined by a pouchitis disease activity index (PDAI) score of < 7 points

Secondary Outcome Measures

Response rate
Defined as a ≥ 3-point reduction in the 18-point PDAI scoring system
Symptomatic improvement rate
Reduction of PDAI clinical subscore >2 points.
Endoscopic improvement rate
Reduction of PDAI endoscopic subscore >2 points.
Fecal calprotectin level
Fecal caprotectin level before and after treatment
Plasma C-reactive protein level
Plasma caprotectin level before and after treatment
Plasma Interleukin-6 level
Plasma Interleukin-6 level before and after treatment
Fecal microbiome
Fecal microbiome analysis using 16S RNA technique before and after treatment
Adverse events
Any adverse event deemed as possibly, probably, or definitely related to investigational treatment during 2-3 weeks of treatment.

Full Information

First Posted
April 14, 2018
Last Updated
May 15, 2018
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT03526796
Brief Title
Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis
Acronym
HBOT-pouch
Official Title
Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis: a Phase 2A Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Anticipated)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pouchitis, Hyperbaric Oxygen Therapy
Keywords
Pouchitis, Hyperbaric oxygen therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperbaric oxygen therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hyperbaric oxygen therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Remission rate
Description
Defined by a pouchitis disease activity index (PDAI) score of < 7 points
Time Frame
up to 4 weeks
Secondary Outcome Measure Information:
Title
Response rate
Description
Defined as a ≥ 3-point reduction in the 18-point PDAI scoring system
Time Frame
up to 4 weeks
Title
Symptomatic improvement rate
Description
Reduction of PDAI clinical subscore >2 points.
Time Frame
up to 4 weeks
Title
Endoscopic improvement rate
Description
Reduction of PDAI endoscopic subscore >2 points.
Time Frame
up to 4 weeks
Title
Fecal calprotectin level
Description
Fecal caprotectin level before and after treatment
Time Frame
up to 4 weeks
Title
Plasma C-reactive protein level
Description
Plasma caprotectin level before and after treatment
Time Frame
up to 4 weeks
Title
Plasma Interleukin-6 level
Description
Plasma Interleukin-6 level before and after treatment
Time Frame
up to 4 weeks
Title
Fecal microbiome
Description
Fecal microbiome analysis using 16S RNA technique before and after treatment
Time Frame
up to 4 weeks
Title
Adverse events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianfeng Gong, MD
Phone
+86-25-80860036
Email
gongjianfeng@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianfeng Gong, MD
Organizational Affiliation
Jinling Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis

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