Effect of CAlcium on intestinal PErmeability and Diarrhea in Ulcerative Colitis

Phase 2

Conditions: chronic intestinal inflammation
inflammatory bowel disease
10017969

Registration Number: NL-OMON32623

Lead Sponsor: Top Institute Food and Nutrition

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

•Patients between 18 and 70 years (inclusive) of age
•A diagnosis of UC, confirmed by conventional endoscopic and histological criteria
•Relapse documented by a SCCAI score boven 2.5
•Exacerbation can be first manifestation of disease or an exacerbation of known disease
•Patients must have tested negative for stool cultures including Clostridium difficile
•Patients who are capable of understanding the purpose and risks of the study and who provided a signed and dated written informed consent

Exclusion Criteria

-UC requiring immediate surgical, or radiological interventions, including massive hemorrhage, perforation and sepsis, suppurative complications (intra-abdominal or peri-anal abscesses) or toxic colon
-investigator judgment that the subject is likely to require a colectomy within 12 weeks of baseline
-history of large bowel surgery or presence of a stoma
-presence or history of a fistula
-patients with serious infections
-significant organ dysfunction (serum creatinine >140 µmol/l, ALT/AST exceeding 3 times the ULN, platelets <100, white blood cells <2.5*109 cell/l)
-some concomitant medication (see protocol)
-pregnant women or nursing mothers
-patients with kidney stones or other illness possibly leading to hypercalceamia or hypercalciuria
-calcium supplement use and unwillingness to stop supplement intake 3 days prior to screening and during the intervention period
-unwillingness to partly restrict dairy intake during the intervention

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>-intestinal permeability<br /><br>-diarrhea</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-percentage patients with a clinical response and clinical remission at 2-4-6-9<br /><br>and 12 weeks<br /><br>-percentage patients needing oral steroids<br /><br>-inflammatory activity as measured by inflammation markers in blood and feces<br /><br>(fecal blood, calprotectin, mucins, and pancreatitis associated protein (PAP))</p><br>