Assessment of Patients With Acute Pouchitis Treated With Antibiotics

NCT05252273 | Suspended

• 1 other identifier: RCT01403
• Study Type: observational
• Target: 43
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Pouchitis; Ulcerative Colitis

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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".

  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."

  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."

  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

  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.

  Week 6

• Histologic Disease Activity

  Trained central histopathology readers will score pouchitis histologic disease.

  Week 6

Other Outcomes (2)

• Blood-based biomarkers of pouchitis disease activity

  Baseline, Week 6

• Stool- based biomarkers of pouchitis disease activity

  Baseline, Week 4, and Week 6

Study Arms (1)

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.

Other: Observational, No intervention

Interventions

Observational, No intervention OTHER

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

Open-label observational study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Forty-three subjects with acute pouchitis are to be enrolled.

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Alimentiv Inc.: lead

Study Sites (4)

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Toronto Immune and Digestive Health Institute (TIDHI).

Toronto, Ontario, M6A 3B4, Canada

Location

Academic Medical Center Amsterdam.

Amsterdam, C2-319, Netherlands

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Blood collection for C-reactive protein, metabolomics, serology, proteomics, and RNA-Sequencing analyses. * Pouchoscopy with biopsies * Stool collection for microbiome, fecal calprotectin, and metabolomic analyses

MeSH Terms

Conditions

Pouchitis; Colitis, Ulcerative

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases; Colitis; Inflammatory Bowel Diseases; Colonic Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 23, 2022
• Study Start: December 7, 2021
• Primary Completion: February 12, 2024
• Study Completion: December 9, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

US (2); NL (1); CA (1)