The Effects of Bromelain Supplement in Patients With Ulcerative Colitis
Not Applicable
Recruiting
- Conditions
- Primary Sclerosing CholangitisUlcerative Colitis
- Interventions
- Dietary Supplement: BromleinOther: Placebo
- Registration Number
- NCT06351696
- Lead Sponsor
- National Nutrition and Food Technology Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Bromlein Bromleine Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method SCCAIQ At the 1st day and 8th week Simple clinical colitis activity index questionnaire (0-19, higher scores means higher symptoms)
- Secondary Outcome Measures
Name Time Method Serum TNF-a At the 1st day and 8th week serum level of tumor necrosis factor-a
IBDQ At the 1st day and 8th week IBD quality of life questionnaire (9-63, higher scores mean higher quality of life)
Serum hsCRP At the 1st day and 8th week serum level of high sensitive C-reactive protein
Serum TAC At the 1st day and 8th week serum level of total anti-oxidant capacity
Trial Locations
- Locations (1)
Azita Hekmatdoost
🇮🇷Tehran, Middle East, Iran, Islamic Republic of