Ileal Pouch Anal Anastomosis Clinical Trial
Official title:
An Exploratory Pilot Study Assessing the Efficacy of Fecal Microbial Transplantation for Clinical and Endoscopic Characteristics of Ileal Pouch Anal Anastomosis Patients
The investigator is hypothesize that an intensive FMT regimen will have superior efficacy the treatment of inflammatory disorders of the pouch (pouchitis and CLDP).
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | December 31, 2024 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: 1. Patients aged 18 to 80 years with a confirmed diagnosis of UC, who underwent IPAA. 2. Endoscopic deterioration or Clinically suspected pouchitis, defined as increased bowel frequency (=1 stools) relative to post-IPAA baseline (1-3 months post IPAA). 3. Clinically stable patients on constant medical regimen throughout the study period. Treated by mesalamine for at least 6 weeks, or steroids at least 2 week, or immunomodulator or biologic at least 12 weeks, medical cannabis at least 2 weeks Exclusion Criteria: 1. Diagnosis of Crohn's disease or indeterminate colitis prior to IPAA. 2. Positive stool test for parasites or stool culture for pathological bacteria within 60 days prior to enrollment. 3. Evidence or history of Clostridium difficile infection within 60 days prior to enrollment. 4. Active clinically significant infection (within 60 days of enrollment). 5. Active septic pouch complication (e.g., abscess, leak, fistula). 6. Post-surgical complication of the pouch (e.g., obstruction, stricture, volvulus, prolapse). 7. Pregnancy or lactation. 8. Unstable or uncontrolled medical disorder (other than suspected pouchitis). 9. Inability to give informed consent and complete the study protocol. 10. Patient participating in other concomitant clinical intervention trial or who had received any experimental drug within a month prior to enrollment 11. Patients received antibiotics within 2 days of enrollment, or are anticipated to use antibiotics or probiotics within the study period (elective surgery or dental care). 12. Patients received fecal transplantation in the last 6 months. 13. Fever>38°c 14. An active malignant disease or a prior malignancy during the previous 5 years (excluding skin BCC). 15. Inability or reluctance to follow through with the study protocol, including (but not exclusive) to: colonoscopy, enema, study visit. |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center | Tel Aviv |
| Lead Sponsor | Collaborator |
|---|---|
| Tel-Aviv Sourasky Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | safety of fecal microbial transplantation in pouch patients by disease exacerbations | determine whether manipulation of gut microbiome by FMT to IPAA patients is safe safety of FMT will be measured by rate of patients with disease exacerbations | 1 year | |
| Primary | safety of fecal microbial transplantation in pouch patients by hospitalizations of patients | determine whether manipulation of gut microbiome by FMT to IPAA patients is safe safety of FMT will be measured by amount of patients that require hospitalizations | 1 year | |
| Primary | safety of fecal microbial transplantation in pouch patients by patients requiring surgery | determine whether manipulation of gut microbiome by FMT to IPAA patients is safe safety of FMT will be measured by amount of patients that require surgery | 1 year | |
| Primary | efficacy of FMT in pouch patients measured by mPDAI decrease | By preforming a pouchoscopy, mPDAI (modified pouchitis disease activity index) will be used to assess decrease of =1 in mPDAI in condition of the pouch comparing to baseline | 2 months | |
| Primary | efficacy of FMT in pouch patients measured by clinical remission | efficacy of FMT in pouch patients will be measured by the amount of patients with clinical remission measured by mPDAI clinical score <3 | 2 months | |
| Secondary | efficacy of FMT in pouch patients measured by amount of patients with sustained remission | Sustained remission as defined by mPDAI endoscopic score = 1 or mPDAI endoscopic and clinical = 5 | 12 months | |
| Secondary | efficacy of FMT in pouch patients measured by amount of patients with sustained clinical remission | Sustained remission as defined by mPDAI clinical <3 | 12 months | |
| Secondary | efficacy of FMT in pouch patients measured by reduce of inflammatory markers | Reduction in inflammatory markers (calprotectin and CRP) | 1 month | |
| Secondary | efficacy of FMT in pouch patients measured by reduce of inflammatory markers | Reduction in inflammatory markers (calprotectin and CRP) | 2 months | |
| Secondary | efficacy of FMT in pouch patients measured by reduce of inflammatory markers | Reduction in inflammatory markers (calprotectin and CRP) | 3 months | |
| Secondary | efficacy of FMT in pouch patients measured by reduce of inflammatory markers | Reduction in inflammatory markers (calprotectin and CRP) | 12 months | |
| Secondary | efficacy of FMT in pouch patients measured by reduce of PGA (physical global assessment) | Reduction in PGA (physical global assessment) comparing to baseline | 1 month | |
| Secondary | efficacy of FMT in pouch patients measured by reduce of PGA (physical global assessment) | Reduction in PGA (physical global assessment) comparing to previous assessments | 2 months | |
| Secondary | efficacy of FMT in pouch patients measured by reduce of PGA (physical global assessment) | Reduction in PGA (physical global assessment) comparing to previous assessments | 3 months | |
| Secondary | efficacy of FMT in pouch patients measured by reduce of PGA (physical global assessment) | Reduction in PGA (physical global assessment) comparing to previous assessments | 12 months | |
| Secondary | efficacy of FMT in pouch patients measured by improvement of life quality | efficacy of FMT by filling questionnaire describing life quality and comparing to baseline to observe improvement | 1 month | |
| Secondary | efficacy of FMT in pouch patients measured by improvement of life quality | efficacy of FMT by filling questionnaire describing life quality and comparing to baseline to observe improvement | 2 months | |
| Secondary | efficacy of FMT in pouch patients measured by improvement of life quality | efficacy of FMT by filling questionnaire describing life quality and comparing to baseline to observe improvement | 3 months | |
| Secondary | efficacy of FMT in pouch patients measured by improvement of life quality | efficacy of FMT by filling questionnaire describing life quality and comparing to baseline to observe improvement | 12 months | |
| Secondary | efficacy of FMT in pouch patients measured by improvement of nutritional status | improvement of patients nutritional status comparing to baseline measured by BMI (body Mass Index). Normal range is BMI of 18.5-25 | 1 month | |
| Secondary | efficacy of FMT in pouch patients measured by improvement of nutritional status | improvement of patients nutritional status comparing to baseline measured by BMI (body Mass Index). Normal range is BMI of 18.5-25 | 2 months | |
| Secondary | efficacy of FMT in pouch patients measured by improvement of nutritional status | improvement of patients nutritional status comparing to baseline measured by BMI (body Mass Index). Normal range is BMI of 18.5-25 | 3 months | |
| Secondary | efficacy of FMT in pouch patients measured by improvement of nutritional status | improvement of patients nutritional status comparing to baseline measured by BMI (body Mass Index). Normal range is BMI of 18.5-25 | 12 months |