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

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ClinicalTrials.gov Identifier: NCT03526796
Recruitment Status : Not yet recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Jianfeng Gong, Jinling Hospital, China

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

Condition or disease Intervention/treatment Phase
Pouchitis Hyperbaric Oxygen Therapy Procedure: Hyperbaric oxygen therapy Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis: a Phase 2A Clinical Trial
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Remission rate [ Time Frame: up to 4 weeks ]
    Defined by a pouchitis disease activity index (PDAI) score of < 7 points


Secondary Outcome Measures :
  1. Response rate [ Time Frame: up to 4 weeks ]
    Defined as a ≥ 3-point reduction in the 18-point PDAI scoring system

  2. Symptomatic improvement rate [ Time Frame: up to 4 weeks ]
    Reduction of PDAI clinical subscore >2 points.

  3. Endoscopic improvement rate [ Time Frame: up to 4 weeks ]
    Reduction of PDAI endoscopic subscore >2 points.

  4. Fecal calprotectin level [ Time Frame: up to 4 weeks ]
    Fecal caprotectin level before and after treatment

  5. Plasma C-reactive protein level [ Time Frame: up to 4 weeks ]
    Plasma caprotectin level before and after treatment

  6. Plasma Interleukin-6 level [ Time Frame: up to 4 weeks ]
    Plasma Interleukin-6 level before and after treatment

  7. Fecal microbiome [ Time Frame: up to 4 weeks ]
    Fecal microbiome analysis using 16S RNA technique before and after treatment

  8. Adverse events [ Time Frame: up to 4 weeks ]
    Any adverse event deemed as possibly, probably, or definitely related to investigational treatment during 2-3 weeks of treatment.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526796


Contacts
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Contact: Jianfeng Gong, MD +86-25-80860036 gongjianfeng@hotmail.com

Locations
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China, Jiangsu
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
Jinling Hospital, China
Investigators
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Principal Investigator: Jianfeng Gong, MD Jinling Hospital, China

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Responsible Party: Jianfeng Gong, Associate Professor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT03526796     History of Changes
Other Study ID Numbers: HBOT-pouchitis
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jianfeng Gong, Jinling Hospital, China:
Pouchitis
Hyperbaric oxygen therapy

Additional relevant MeSH terms:
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Pouchitis
Ileitis
Enteritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ileal Diseases
Anti-Bacterial Agents
Anti-Infective Agents