Antibiotic treatment (Rifaxamin) of a chronic inflammatory diarrhoeal disease (Collagenous Colitis)

Phase 1

• Conditions: Collagenous Colitis; MedDRA version: 20.0Level: LLTClassification code 10048928Term: Colitis collagenousSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-001891-39-DK
• Lead Sponsor: XiCoCo study group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-02
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

•Age >18 years
•Written informed consent
•Histological findings fulfill criteria for CC:
oA thickenened subepithelial collagenous band >10 µm in veloriented colonic biopsies and
oIncreased count of inflammatory cells in lamina propria
•Diagnostic biopsies are a maximum of two years old
•A history of nonbloody, watery diarrhea for more than two weeks prior to screening in patients with recently diagnosed CC or a history of clinical relapse for more than a week in patients with known CC
•Active disease: > 3 stools/day or >1 watery stool/day measured as a mean during a week prior to baseline

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 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

-Significant findings at colonoscopy that could cause diarrhea (colonic diverticulosis and polyps < 2 cm are not considered significant findings)
-Biopsies more than two years old in a patient, who does not accept a new sigmoidoscopy
-Untreated celiac disease
-Positive stool cultures for pathogenic intestinal bacteria including Clostridium difficile
-Suspected colitis induced by medication (diarrhea shortly after commencement of NSAID’s, statins, SSRI or PPI)
-Severe comorbidity (cardiovascular, renal, endocrine, neurologic, pulmonal or psychiatric) or history of cancer during the last 5 years
-Abnormal liver biochemistry (ALAT or ALP > 2,5 x upper limit), cirrhosis or portal hypertension
-Pregnancy or lactation (assured by negative P-hCG at inclusion)
-History of significant intestinal resection
-Treatment with 5-ASA, Salazopyrin, immunomudulators (Azathioprine, 6-mercaptopurine or Methotrexate), biologic drugs (TNF-alfa-inhibitors), systemic or rectal administered glucocorticoids (except for Budesonide) within the last three month
-Allergy or intolerance to Rifaximin (or similar antibiotics such as Rifampicin or Rifabutin)
-Expectation of lack of cooperation or insufficient comprehension
-Concomitant participation in an other clinical trial or participation within the last 30 days
-Patients receiving Warfarin or Marcoumar (interaction with risk of uncontrolled INR-levels)

Study & Design

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