Primary Sclerosing Cholangitis, Ulcerative Colitis
Conditions
Brief summary
In this study, patients with active mild to moderate UC with or without PSC will be randomized to receive either bromlein or placebo along with low FODMAP diet for 8 weeks. IBDQ, SCCAIQ, CRP, TAC, TNF-a will be measured before and after the intervention.
Interventions
DIETARY_SUPPLEMENTBromlein
1500 mg/day
OTHERPlacebo
Placebo (1500 mg/day)
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* active mild to moderate UC * no other chronic disorders
Exclusion criteria
* changed the type and dosage of their medication in the last month * those who have relapses that required hospitalization and change the type and dosage of medications during the intervention * patients who do not want to continue the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SCCAIQ | At the 1st day and 8th week | Simple clinical colitis activity index questionnaire (0-19, higher scores means higher symptoms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IBDQ | At the 1st day and 8th week | IBD quality of life questionnaire (9-63, higher scores mean higher quality of life) |
| Serum TAC | At the 1st day and 8th week | serum level of total anti-oxidant capacity |
| Serum hsCRP | At the 1st day and 8th week | serum level of high sensitive C-reactive protein |
| Serum TNF-a | At the 1st day and 8th week | serum level of tumor necrosis factor-a |
Countries
Iran
Contacts
Primary ContactAzita Hekmatdoost, MD, PhD
Backup ContactReihaneh Samieeian, MSc
Outcome results
None listed