Sandostatin® in the treatment of diarrhea in patients with ileal pouch anal anastomosis. - pouchitis

Phase 1

• Conditions: IPAAPouchitis

• Registration Number: EUCTR2006-005642-37-BE
• Lead Sponsor: niversity of Leuven, Division of Gastroenterology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-03-06
• Study Completion: 2011-03-10
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Patients with IPAA, who have had a functioning pouch without ileostomy for at least 6 months.
- A stool frequency of 7 or more loose stools in 24 hrs. for at least 7 consecutive days
prior to inclusion.
- Stable dose of loperamide or antibiotics for at least 7 days prior to inclusion.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Evidence of ongoing or recent (within 14 days) enteritis or positive stool culture for
enteric pathogens or C difficile toxin positivity.
- Short bowel syndrome.
- Pouch related fistula or stenosis of pouch outlet.
- Female patients who are pregnant or lactating, or are of childbearing potential and not
practicing a medically acceptable method for birth control.
- Known allergy to Sandostatin? or one of its compounds.
- Symptomatic cholelithiasis
- Poorly controlled Diabetes Mellitus : Hba1c > 10 %.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified