PouchitisNCT05252273
Assessment of Patients With Acute Pouchitis Treated With Antibiotics
An observational study of Pouchitis and Ulcerative Colitis, run by Alimentiv Inc. at 4 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the reliability and responsiveness of symptoms, endoscopic, and histological items for assessing pouchitis disease activity in patients undergoing standard of care (SOC) antibiotic therapy for treatment of pouchitis, in order to develop a novel pouchitis disease activity index. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pouchitis, Ulcerative Colitis
- How many people
- 43 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 7 Dec 2021to 9 Dec 2024
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Forty-three subjects with acute pouchitis are to be enrolled.
Who may be able to join
- Adult patients ≥ 18 years of age
- IPAA for UC (J-pouch only) ≥ 6 months prior to screening
- Diagnosis of acute pouchitis at screening by stool frequency (an absolute value of ≥ 6 stools / day AND an increase of ≥ 3 stools / day above the post-IPAA baseline), and local endoscopy (presence of ≥ 1 erosion or ulceration of the pouch on endoscopy [not including ulceration occurring within 1 cm of the pouch staple or pouch suture line]).
- Not currently taking antibiotics for pouchitis or previous systemic antibiotic use for any reason within 4 weeks of screening. Prior to the Screening pouchoscopy. Note: Initiation of antibiotics for treatment of acute pouchitis prior to the Screening pouchoscopy will be permitted only if the participant initiates treatment within 48 hours prior to the Screening pouchoscopy; use outside of the 48-hour window will not be permitted and these patients should not be included in the study
- Current treatment with 5-aminosalicylic acid drugs, immunosuppressants, antidiarrheals, antimotility agents, and probiotics is permitted, if patient has received a stable dose for ≥ 4 weeks prior to screening. Dose of concomitant therapy must remain stable during the study period.
- Able to participate fully in all aspects of this clinical trial.
- Written informed consent must be obtained and documented
Who cannot join
- Pouch formations besides J-pouch (e.g., W-, S- and Kock pouches).
- IPAA for familial adenomatous polyposis.
- Pouchitis caused by other inflammatory etiologies (e.g., ischemia or infection).
- Antibiotic-dependent pouchitis, defined by ≥ 3 months of cumulative antibiotic use over the 12 months prior to screening.
- Isolated cuffitis, pouch-anal or pouch-ileal anastomotic stricture, perforating complications, or pelvic sepsis.
- Known Crohn's disease (CD) or suspected CD of the pouch, defined as complex perianal/pouch fistula and/or extensive length of prepouch ileitis with deep ulceration.
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- Anticipated changes in therapy during study period.
- Use of oral corticosteroids. Participants must have discontinued oral corticosteroids within 1 month prior to screening.
- Current use of any advanced oral small molecule drug (e.g Janus kinase [JAK] inhibitors for the treatment of pouchitis. Participants must have discontinued oral small molecule therapy within 2 weeks prior to screening.
- Failed (i.e., inadequate response with, loss of response to, or intolerance to) 2 or more compounds or classes of advanced therapies such as biologics and/or small molecule drugs (i.e., 1 biologic and 1 JAK inhibitor, 2 biologics in the same class, or 2 biologics from different classes) for the treatment of pouchitis
- Participant who are pregnant or breastfeeding.
- Known history of allergy, intolerance, or are refractory to ciprofloxacin AND metronidazole AND any component of amoxicillin/potassium clavulanate combination.
- Unable to undergo endoscopic evaluation.
- Serious underlying disease other than acute pouchitis and UC that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study.
- History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures.
- Prior enrollment in the current study.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Mount Sinai Hospital
New York, New York, 10029
Canada1 site
Toronto Immune and Digestive Health Institute (TIDHI).
Toronto, Ontario, M6A 3B4
About this study
Official title: Assessment of Patient-reported Symptoms and Endoscopic, Histologic, and Biomarker Outcomes in Patients With Acute Pouchitis Treated With Antibiotics
The purpose of this study is to evaluate the reliability and responsiveness of symptoms, endoscopic, and histological items for assessing pouchitis disease activity in patients undergoing standard of care (SOC) antibiotic therapy for treatment of pouchitis, in order to develop a novel pouchitis disease activity index.
Read the detailed description
This is a prospective, open-label observational study of patients with acute pouchitis being treated with SOC antibiotic therapy (a known effective therapy in most patients), to evaluate the reliability and responsiveness of existing pouchitis indices and component items for assessing pouchitis disease activity. A total of 43 subjects will be recruited and enrolled at clinical sites in North America and Europe. All subjects with suspected acute pouchitis will undergo pouchoscopy with biopsies and blood and stool sample collection at screening and receive 28 days of antibiotic therapy. Subjects will return to the clinic for a follow-up clinical assessment, pouchoscopy with biopsies forendoscopic and histologic assessments of disease activity, respectively, and blood and stool sample collection for inflammatory biomarker, molecular, and microbiome analyses approximately 6 weeks after starting antibiotic therapy. Subjects will collect an additional stool sample for fecal calprotectin (FC) and microbiome analyses and metabolomics at Week 4 and return the sample to the clinic in person or by mail. Subjects will rate their pouchitis symptoms in an electronic diary beginning at least 3 days before initiation of antibiotic therapy through to the Week 6 study visit. Total anticipated duration of subject participation is approximately 6 weeks after initiating antibiotic therapy.
Endoscopic and Histologic Disease Activity Assessments: Blinded expert endoscopists and histopathologists will serve as central readers for this study and score pouchoscopy videos and histologic slide images, respectively. Paired pouchoscopy videos and histologic slide images (baseline and Week 6) of adequate quality will be scored by central readers (see Outcome Measures). Each central reader will score all Week 6 pouchoscopy videos and histologic slide images twice, 2 weeks apart, for assessing reliability, and all baseline pouchoscopy videos/slide images once to be compared to scores posttreatment scores for assessing responsiveness.
Novel Pouchitis Disease Activity Index Development: A novel index will be developed using multiple linear regression with items that have moderate reliability and responsiveness. The index will be internally validated using the bootstrap method with 2000 replicates.
Primary Objective:
The primary objective of this study is to evaluate the reliability and responsiveness of patient-reported symptoms and endoscopic and histologic items for assessing pouchitis disease activity in patients undergoing standard of care (SOC) antibiotic therapy.
Secondary Objective:
A secondary objective of this study is to develop a novel index for assessing pouchitis disease activity.
Exploratory Objectives:
- Identify biomarkers associated with (non)response to antibiotics in pouchitis;
- Identify biomarkers associated with patient-reported symptoms, endoscopic, and histologic component scores and items, and pouchitis disease activity indices;
- Describe the dynamics of the microbiome following introduction and withdrawal of antibiotics in pouchitis.
Additional exploratory analyses may be established during the review of the study results.
- Conditions
- Pouchitis, Ulcerative Colitis
- Being tested
- Observational, No intervention
- Medical subject headings
- Pouchitis, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational, No interventionOther
Also called Observational
Open-label observational study that will evaluate the reliability and responsiveness of patient-reported symptoms and endoscopic and histologic items for assessing pouchitis disease activity in 43 patients undergoing standard of care (SOC) antibiotic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Open-label observational study | This study will evaluate the reliability and responsiveness of patient-reported symptoms and endoscopic and histologic items for assessing pouchitis disease activity in 43 patients undergoing standard of care (SOC) antibiotic therapy. Receives: Other: Observational, No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Screening Clinical Global Impressions of Severity at Week 6
Site investigators will rate the severity of pouchitis symptoms using the Clinical Global Impressions of Severity (CGI-S) at baseline and Week 6 and change in pouchitis symptoms using the CGI of Change (CGI-C) scale at Week 6.
Measured: Baseline and Week 6
Change from Screening Patient's Global Impression of Severity at Week 6
Participants will rate their symptoms using the Patient's Global Impression of Severity (PGI-S) at beginning at least 3 days prior to initiating antibiotic therapy through to Week 6. The weekly component will be completed at baseline and every 7 days following initiation of therapy. Change in symptoms using the PGI of Change (PGI-C) scale will be completed at Week 4 and Week 6.
Measured: Duration of study, approximately 6 weeks.
Symptoms and Impacts Questionnaire for Pouchitis
The Symptoms and Impacts Questionnaire for Pouchitis (SIQ-UC) is a self-administered tool that includes daily records of bowel movements, symptoms, and an assessment of ulcerative colitis impact on activities of daily living. For this study, the SIQ-UC has been adapted for use in pouchitis.
Measured: Duration of study, approximately 6 weeks
Visual Analog Scale for Pouchitis Symptoms
Throughout the study, participants will rate their pouchitis symptoms daily on a 100-mm VAS,where 0 indicates "no pouchitis symptoms," and 100 indicates the "worst pouchitis symptoms ever".
Measured: Duration of study, approximately 6 weeks
Visual Analog Scale of Fecal Urgency
Throughout the study, participants will rate fecal urgency on a 100-mm VAS, where 0 indicates "no sense of urgency to defecate" and 100 indicates "I was not able to make it to the toilet in time."
Measured: Duration of study, approximately 6 weeks
Visual Analog Scale of Abdominal Cramps Severity
Throughout the study, participants will rate fecal urgency on a 100-mm VAS, where 0 indicates "no abdominal cramps" and 100 indicates " worst abdominal cramps ever."
Measured: Duration of study, approximately 6 weeks
Change from Baseline St. Mark's Fecal Incontinence Score (Vaizey Score) at Week 6
The St. Mark's Fecal Incontinence Score (Vaizey Score) will be completed at Screening and EOS (Week 6). Four items for incontinence and lifestyle impact are assessed on a 5-point frequency scale and 3 items are assessed with a binary yes/no response to provide a total score ranging from 0 to 24 points, with higher scores indicating greater fecal incontinence and impact on lifestyle
Measured: Baseline and Week 6
Endoscopic Disease Activity
Trained central endoscopy readers will score pouchitis endoscopic disease activity in the worst affected area of the pouch body.
Measured: Week 6
Histologic Disease Activity
Trained central histopathology readers will score pouchitis histologic disease.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start7 Dec 2021
- Primary completion12 Feb 2024 (estimated)
- Study completion9 Dec 2024 (estimated)
Why it stopped: This decision has been made after careful consideration and evaluation of trial progress and ongoing recruitment challenges.
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 43 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Alimentiv Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252273
- Sponsor's protocol ID
- RCT01403
- Status last verified
- Feb 2024
- First submitted
- 6 Jan 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient-reported Symptoms and Endoscopic, Histologic, and Biomarker Outcomes in Patients With Acute Pouchitis Treated With Antibiotics
- ClinicalTrials.gov ID
- NCT05252273
- Acronym / sponsor ID
- RCT01403
- Conditions
- Pouchitis, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: This decision has been made after careful consideration and evaluation of trial progress and ongoing recruitment challenges.
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Alimentiv Inc.University, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 12 Feb 2024 (estimated)
- Study completion
- 9 Dec 2024 (estimated)
- First posted
- 23 Feb 2022 (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 purpose of this study is to evaluate the reliability and responsiveness of symptoms, endoscopic, and histological items for assessing pouchitis disease activity in patients undergoing standard of care (SOC) antibiotic therapy for treatment of pouchitis, in order to develop a novel pouchitis disease activity index.
Detailed description
This is a prospective, open-label observational study of patients with acute pouchitis being treated with SOC antibiotic therapy (a known effective therapy in most patients), to evaluate the reliability and responsiveness of existing pouchitis indices and component items for assessing pouchitis disease activity. A total of 43 subjects will be recruited and enrolled at clinical sites in North America and Europe. All subjects with suspected acute pouchitis will undergo pouchoscopy with biopsies and blood and stool sample collection at screening and receive 28 days of antibiotic therapy. Subjects will return to the clinic for a follow-up clinical assessment, pouchoscopy with biopsies forendoscopic and histologic assessments of disease activity, respectively, and blood and stool sample collection for inflammatory biomarker, molecular, and microbiome analyses approximately 6 weeks after starting antibiotic therapy. Subjects will collect an additional stool sample for fecal calprotectin (FC) and microbiome analyses and metabolomics at Week 4 and return the sample to the clinic in person or by mail. Subjects will rate their pouchitis symptoms in an electronic diary beginning at least 3 days before initiation of antibiotic therapy through to the Week 6 study visit. Total anticipated duration of subject participation is approximately 6 weeks after initiating antibiotic therapy.
Endoscopic and Histologic Disease Activity Assessments: Blinded expert endoscopists and histopathologists will serve as central readers for this study and score pouchoscopy videos and histologic slide images, respectively. Paired pouchoscopy videos and histologic slide images (baseline and Week 6) of adequate quality will be scored by central readers (see Outcome Measures). Each central reader will score all Week 6 pouchoscopy videos and histologic slide images twice, 2 weeks apart, for assessing reliability, and all baseline pouchoscopy videos/slide images once to be compared to scores posttreatment scores for assessing responsiveness.
Novel Pouchitis Disease Activity Index Development: A novel index will be developed using multiple linear regression with items that have moderate reliability and responsiveness. The index will be internally validated using the bootstrap method with 2000 replicates.
Primary Objective:
The primary objective of this study is to evaluate the reliability and responsiveness of patient-reported symptoms and endoscopic and histologic items for assessing pouchitis disease activity in patients undergoing standard of care (SOC) antibiotic therapy.
Secondary Objective:
A secondary objective of this study is to develop a novel index for assessing pouchitis disease activity.
Exploratory Objectives:
- Identify biomarkers associated with (non)response to antibiotics in pouchitis;
- Identify biomarkers associated with patient-reported symptoms, endoscopic, and histologic component scores and items, and pouchitis disease activity indices;
- Describe the dynamics of the microbiome following introduction and withdrawal of antibiotics in pouchitis.
Additional exploratory analyses may be established during the review of the study results.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label observational study | – | Other: Observational, No interventionThis study will evaluate the reliability and responsiveness of patient-reported symptoms and endoscopic and histologic items for assessing pouchitis disease activity in 43 patients undergoing standard of care (SOC) antibiotic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Forty-three subjects with acute pouchitis are to be enrolled.
Key inclusion criteria (7 listed)
- Adult patients ≥ 18 years of age
- IPAA for UC (J-pouch only) ≥ 6 months prior to screening
- Diagnosis of acute pouchitis at screening by stool frequency (an absolute value of ≥ 6 stools / day AND an increase of ≥ 3 stools / day above the post-IPAA baseline), and local endoscopy (presence of ≥ 1 erosion or ulceration of the pouch on endoscopy [not including ulceration occurring within 1 cm of the pouch staple or pouch suture line]).
- Not currently taking antibiotics for pouchitis or previous systemic antibiotic use for any reason within 4 weeks of screening. Prior to the Screening pouchoscopy. Note: Initiation of antibiotics for treatment of acute pouchitis prior to the Screening pouchoscopy will be permitted only if the participant initiates treatment within 48 hours prior to the Screening pouchoscopy; use outside of the 48-hour window will not be permitted and these patients should not be included in the study
- Current treatment with 5-aminosalicylic acid drugs, immunosuppressants, antidiarrheals, antimotility agents, and probiotics is permitted, if patient has received a stable dose for ≥ 4 weeks prior to screening. Dose of concomitant therapy must remain stable during the study period.
Key exclusion criteria (16 listed)
- Pouch formations besides J-pouch (e.g., W-, S- and Kock pouches).
- IPAA for familial adenomatous polyposis.
- Pouchitis caused by other inflammatory etiologies (e.g., ischemia or infection).
- Antibiotic-dependent pouchitis, defined by ≥ 3 months of cumulative antibiotic use over the 12 months prior to screening.
- Isolated cuffitis, pouch-anal or pouch-ileal anastomotic stricture, perforating complications, or pelvic sepsis.
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 |
|---|---|---|
| Observational, No interventionAlso: ObservationalOpen-label observational study that will evaluate the reliability and responsiveness of patient-reported symptoms and endoscopic and histologic items for assessing pouchitis disease activity in 43 patients undergoing standard of care (SOC) antibiotic therapy. | Other | Open-label observational study |
Primary outcome
Change from Screening Clinical Global Impressions of Severity at Week 6
Time frame: Baseline and Week 6
Site investigators will rate the severity of pouchitis symptoms using the Clinical Global Impressions of Severity (CGI-S) at baseline and Week 6 and change in pouchitis symptoms using the CGI of Change (CGI-C) scale at Week 6.
Change from Screening Patient's Global Impression of Severity at Week 6
Time frame: Duration of study, approximately 6 weeks.
Participants will rate their symptoms using the Patient's Global Impression of Severity (PGI-S) at beginning at least 3 days prior to initiating antibiotic therapy through to Week 6. The weekly component will be completed at baseline and every 7 days following initiation of therapy. Change in symptoms using the PGI of Change (PGI-C) scale will be completed at Week 4 and Week 6.
Symptoms and Impacts Questionnaire for Pouchitis
Time frame: Duration of study, approximately 6 weeks
The Symptoms and Impacts Questionnaire for Pouchitis (SIQ-UC) is a self-administered tool that includes daily records of bowel movements, symptoms, and an assessment of ulcerative colitis impact on activities of daily living. For this study, the SIQ-UC has been adapted for use in pouchitis.
Visual Analog Scale for Pouchitis Symptoms
Time frame: Duration of study, approximately 6 weeks
Throughout the study, participants will rate their pouchitis symptoms daily on a 100-mm VAS,where 0 indicates "no pouchitis symptoms," and 100 indicates the "worst pouchitis symptoms ever".
Visual Analog Scale of Fecal Urgency
Time frame: Duration of study, approximately 6 weeks
Throughout the study, participants will rate fecal urgency on a 100-mm VAS, where 0 indicates "no sense of urgency to defecate" and 100 indicates "I was not able to make it to the toilet in time."
Visual Analog Scale of Abdominal Cramps Severity
Time frame: Duration of study, approximately 6 weeks
Throughout the study, participants will rate fecal urgency on a 100-mm VAS, where 0 indicates "no abdominal cramps" and 100 indicates " worst abdominal cramps ever."
Change from Baseline St. Mark's Fecal Incontinence Score (Vaizey Score) at Week 6
Time frame: Baseline and Week 6
The St. Mark's Fecal Incontinence Score (Vaizey Score) will be completed at Screening and EOS (Week 6). Four items for incontinence and lifestyle impact are assessed on a 5-point frequency scale and 3 items are assessed with a binary yes/no response to provide a total score ranging from 0 to 24 points, with higher scores indicating greater fecal incontinence and impact on lifestyle
Endoscopic Disease Activity
Time frame: Week 6
Trained central endoscopy readers will score pouchitis endoscopic disease activity in the worst affected area of the pouch body.
Histologic Disease Activity
Time frame: Week 6
Trained central histopathology readers will score pouchitis histologic disease.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pouchitis and Ulcerative Colitis, run by Alimentiv Inc. at 4 sites in 3 countries.
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 16 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: paused, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada, Netherlands. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Screening Clinical Global Impressions of Severity at Week 6 (time frame: Baseline and Week 6). The study lists 9 primary outcomes in all. 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 20 Feb 2024.