An observational study in Pouchitis and Ulcerative Colitis, sponsored by Alimentiv Inc.. Suspended at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by Alimentiv Inc. · Observational
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.
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:
Additional exploratory analyses may be established during the review of the study results.
50 studies on the registry are indexed under Pouchitis; 12 are open to participants now.
Browse Pouchitis studies →Alimentiv Inc. is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
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Forty-three subjects with acute pouchitis are to be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Observational, No intervention
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.
Also known as: Observational
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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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."
Time frame: 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."
Time frame: 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
Time frame: 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.
Time frame: Week 6
Histologic Disease Activity
Trained central histopathology readers will score pouchitis histologic disease.
Time frame: Week 6
Blood-based biomarkers of pouchitis disease activity
Blood samples will be collected to identify biomarkers of pouchitis disease activity.
Time frame: Baseline, Week 6
Stool- based biomarkers of pouchitis disease activity
Stool samples will be collected to identify biomarkers of pouchitis disease activity.
Time frame: Baseline, Week 4, and Week 6
Started Dec 2021 (actual). Primary completion is estimated for Feb 2024, 26 months after the start.
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This study is suspended, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Alimentiv Inc.