PouchitisHBOT-pouchNCT03526796
Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis
A study testing Hyperbaric oxygen therapy in people with Pouchitis and Hyperbaric Oxygen Therapy, run by Jinling Hospital, China at 1 site in China.
Trial summary
The aim of current study is to evaluate the effect of hyperbaric oxygen therapy for the treatment of chronic antibiotic-refractory pouchitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pouchitis, Hyperbaric Oxygen Therapy
- What is being tested?
- Hyperbaric oxygen therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Crohn's disease of the pouch
- Pouchitis after IPAA for FAP
- Isolated cuffitis
- with cocomttant Primary sclerosing cholangitis (PSC)
- Pouch strictures
- Abscess/Sinuses
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
China1 site
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, 210000
About this study
Official title: 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.
Read the 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).
- Conditions
- Pouchitis, Hyperbaric Oxygen Therapy
- Being tested
- Hyperbaric oxygen therapy
- Keywords
- Pouchitis, Hyperbaric oxygen therapy
- Medical subject headings
- Pouchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric oxygen therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Hyperbaric oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission rate
Defined by a pouchitis disease activity index (PDAI) score of < 7 points
Measured: up to 4 weeks
Secondary outcomes (8)
Response rate
Defined as a ≥ 3-point reduction in the 18-point PDAI scoring system
Measured: up to 4 weeks
Symptomatic improvement rate
Reduction of PDAI clinical subscore >2 points.
Measured: up to 4 weeks
Endoscopic improvement rate
Reduction of PDAI endoscopic subscore >2 points.
Measured: up to 4 weeks
Fecal calprotectin level
Fecal caprotectin level before and after treatment
Measured: up to 4 weeks
Plasma C-reactive protein level
Plasma caprotectin level before and after treatment
Measured: up to 4 weeks
Plasma Interleukin-6 level
Plasma Interleukin-6 level before and after treatment
Measured: up to 4 weeks
Fecal microbiome
Fecal microbiome analysis using 16S RNA technique before and after treatment
Measured: 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.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start1 Jun 2018 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PouchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Gong, Jinling Hospital, China
- Investigators
- Jianfeng Gong, MD, Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526796
- Sponsor's protocol ID
- HBOT-pouchitis
- Acronym
- HBOT-pouch
- Status last verified
- May 2018
- First submitted
- 14 Apr 2018
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy for Antibiotic Refractory Pouchitis: a Phase 2A Clinical Trial
- ClinicalTrials.gov ID
- NCT03526796
- Acronym / sponsor ID
- HBOT-pouch / HBOT-pouchitis
- Conditions
- Pouchitis, Hyperbaric Oxygen Therapy
- Keywords
- Pouchitis, Hyperbaric oxygen therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy | Experimental | Procedure: Hyperbaric oxygen therapyPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- Crohn's disease of the pouch
- Pouchitis after IPAA for FAP
- Isolated cuffitis
- with cocomttant Primary sclerosing cholangitis (PSC)
- Pouch strictures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric oxygen therapyPatients 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. | Procedure or surgery | Hyperbaric oxygen therapy |
Primary outcome
Remission rate
Time frame: up to 4 weeks
Defined by a pouchitis disease activity index (PDAI) score of < 7 points
8 secondary outcomes
Response rate
Time frame: up to 4 weeks
Symptomatic improvement rate
Time frame: up to 4 weeks
Endoscopic improvement rate
Time frame: up to 4 weeks
Fecal calprotectin level
Time frame: up to 4 weeks
Plasma C-reactive protein level
Time frame: up to 4 weeks
Plasma Interleukin-6 level
Time frame: up to 4 weeks
Fecal microbiome
Time frame: up to 4 weeks
Adverse events
Time frame: up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianfeng Gong, MD principal investigator
Jinling Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric oxygen therapy in people with Pouchitis and Hyperbaric Oxygen Therapy, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianfeng Gong, MD (+86-25-80860036, gongjianfeng@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission rate (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.