Study Design:
An open label non-controlled clinical trial.
Study population:
Patients aged 18 to 80 years with a confirmed diagnosis of UC , who underwent IPAA.
Recruitment of the study population:
Patients will be enrolled at the Pouch Clinic of the Tel Aviv Medical Center Inflammatory Bowel Disease Center and at the Department of Colorectal Surgery.
Study procedure:
The study includes six visits to the IBD clinic and phone calls between visits. At baseline, after 8 weeks and after one year of intervention, all patients will undergo pouchoscopy which will be recorded and scored for pouch endoscopic score (Appendix 2). In all three procedures, samples will be collected for future analysis.
According to their endoscopic evaluation at baseline, patients will be categorized as those with an inflamed pouch (cuff, afferent loop, pouch inlet, J-pouch, pouch outlet or pouch mid-line scare) or non inflamed pouch (irritable pouch patients) according to a pouch endoscopic score (PES) and the modified pouch disease activity index endoscopic domain (mPDAI).
Baseline pouchoscopy will include FMT, followed by capsule FMT after 1 week (15 capsules), and after 4 weeks of the study.
All patients will undergo clinical followup at week 4 of the study (mPDAI clinical domain, PCS and PGA) and a second pouchoscopy after 8 weeks.
Clinical follow up will be performed at week 12 of the study, and an annual endoscopic follow up will be preformed at 52 weeks or per personal indication.
Data collection at baseline and follow-up visits will include:
1. Clinical assessment:
* Pouch clinical score (PCS)
* mPDAI - clinical domains
* Physician Global Assessment (PGA)
* Pouch endoscopic score (PES)
2. Collection of biological samples:
* Stool for analysis of calprotectin level and microbiome
* Urine for analysis of metabolomics
* Serum for analysis of complete blood count (CBC), serum levels of C-Reactive Protein (CRP), albumin, creatinine, liver enzymes
* Tissue samples collected during pouchoscopy at baseline and followup - samples will be collected from the cuff, pouch body and pouch inlet.
3. Anthropocentric measures will be assessed (weight, height)
4. Complete study questionnaires:
* A validated lifestyle and food frequency questionnaire (FFQ)
* Three day food diary
* Quality of life questionnaire (SF-12)
* Patient-reported outcomes (PRO) Measurement Information System (PROMIS)
* Life style questionnaire
Safety assessments:
will include history taking, vital signs, physical examinations and laboratory analysis during each visit. Patients who discontinue the trial treatment will continue to be followed as per protocol. Follow-up will be discontinued in patients who withdraw informed consent or are lost for follow-up. All adverse events will be registered as: unrelated, possible related, likely related or definitely related to the intervention. SAEs will be communicated immediately to the IRB.
