Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouch... | NCT03526796

Studies
Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis

NCT03526796

Sponsor

Jinling Hospital, China

Status

Unknown status

Last Update Posted

May 16, 2018Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Pouchitis
Hyperbaric Oxygen Therapy

Interventions

Hyperbaric oxygen therapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Estimated

Primary Completion Date

May 2020Estimated

Completion Date

Jul 2020Estimated

First Submitted Date

Apr 14, 2018

First Submission Date that Met QC Criteria

May 15, 2018

First Posted Date

May 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2018

Last Update Posted Date

May 16, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyperbaric oxygen therapy	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hyperbaric oxygen therapy	Procedure	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jianfeng Gong, MD	Contact	+86-25-80860036		gongjianfeng@hotmail.com

Overall Officials

Name	Affiliation	Role
Jianfeng Gong, MD	Jinling Hospital, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University		Nanjing	Jiangsu	210000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D019449	Pouchitis

ID	Term
D007079	Ileitis
D004751	Enteritis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D006931	Hyperbaric Oxygenation

Ancestor Terms

ID	Term
D010102	Oxygen Inhalation Therapy
D012138	Respiratory Therapy
D013812	Therapeutics

Browse Leaves

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Browse Branches

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