chronic intestinal inflammation inflammatory bowel disease
Conditions
Interventions
Subjects will receive tablets with or without 500 mg calcium twice daily for 12
weeks.
Sponsors
Top Institute Food and Nutrition
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -intestinal permeability -diarrhea | — |
Secondary
| Measure | Time frame |
|---|---|
| -percentage patients with a clinical response and clinical remission at 2-4-6-9 and 12 weeks -percentage patients needing oral steroids -inflammatory activity as measured by inflammation markers in blood and feces (fecal blood, calprotectin, mucins, and pancreatitis associated protein (PAP)) | — |
Countries
Netherlands
Outcome results
None listed