The Role of Secondary Bile Acids in Intestinal Inflammation (NCT03724175) | Clinical Trial Compass
TerminatedPhase 2/3
The Role of Secondary Bile Acids in Intestinal Inflammation
Stopped: Lack of recruitment and funding.
United States2 participantsStarted 2019-08-26
Plain-language summary
The cause of Inflammatory bowel disease (IBD) is unknown, but intestinal bacteria-involved in the production of molecules that impact health-are widely accepted to play a key role. A significant proportion of IBD patients with pouches (surgically created rectums after the diseased colon is removed) continue to have inflammation similar to their previous disease.
Only a few microbes are known to have the capability to modify primary bile acids (PBAs) made by the liver to secondary bile acids (SBAs). SBAs are some of the most common metabolites in the colon and play key roles in several diseases.
In this study the investigators will investigate if ursodeoxycholic acid (UDCA) may reduce inflammatory markers and improve quality of life (as assessed by validate survey) in those subjects with active antibiotic refractory or antibiotic dependent pouchitis.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Written informed consent;
✓. Male or female subjects, ≥18 years of age who have undergone an ileal pouch-anal anastomosis (IPAA) for UC.
✓. History of pouchitis
✓. Endoscopic score \>=2 on the endoscopic component of a modified Mayo endoscopic score (where friability is scored as \>2) Note: the area within 1 cm of the pouch staple, or pouch suture line, is not considered evaluable
✓. Symptomatic disease (stool frequency):
✓. Histology: evidence of disease.
✓. Modified PDAI (mPDAI) score \>= 5. The mPDAI consists of the symptom (range: 0-6) and endoscopy (range: 0-6) subscores.
✓. Must have chronic antibiotic refractory or antibiotic dependent pouchitis.
Exclusion criteria
✕. Lack of effective contraception Women of childbearing potential may not participate unless they are surgically sterile or are using adequate contraception.
What they're measuring
1
Proportion of subjects who achieve clinical response at week 10.
Timeframe: change from screening to end of treatment (10 weeks)
✕. Changes in dose to strong analgesia, such as opioid containing compounds within 4 weeks of the Screening Visit.
✕. History of regular nonsteroidal anti-inflammatory drugs (NSAID) use.
✕. Oral 5-aminosalicylate (5-ASA) compounds; exclude subjects who have discontinued or changed doses of oral 5-ASA within 4 weeks of the Screening Visit.
✕. Oral budesonide \> 6.0 mg/day is not permitted; exclude subjects who have received budesonide for \< 6 weeks, or who have changed doses of budesonide within 4 weeks of the Screening Visit.
✕. Oral steroids other than budesonide: exclude subjects who exceed a daily dose of 15 mg prednisolone or equivalent, who have received oral steroids for \< 6 weeks, or who have changed dose within 4 weeks of the Screening Visit.