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

J

Jinling Hospital, China

Status

Unknown

Conditions

Hyperbaric Oxygen Therapy
Pouchitis

Treatments

Procedure: Hyperbaric oxygen therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03526796
HBOT-pouchitis

Details and patient eligibility

About

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

Full 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).

Enrollment

20 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Hyperbaric oxygen therapy
Experimental group
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.
Treatment:
Procedure: Hyperbaric oxygen therapy

Trial contacts and locations

1

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Central trial contact

Jianfeng Gong, MD

Data sourced from clinicaltrials.gov

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