Effects of Bromelain on Ulcerative Colitis
The Effects of Low FODMAP Diets Accompanied With and Without Bromelain Supplement on Quality of Life, Disease Activity Index and Inflammation in Patients With Ulcerative Colitis With and Without Primary Sclerosis Cholangitis
This study tests whether taking bromelain can help people with mild to moderate ulcerative colitis feel better while they follow a low FODMAP diet.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | National Nutrition and Food Technology Institute Academic / other |
| Locations | 1 site (Tehran, Middle East) |
| Trial ID | NCT06351696 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of bromelain supplementation in patients with active mild to moderate ulcerative colitis, with or without primary sclerosing cholangitis. Participants will be randomly assigned to receive either bromelain or a placebo, alongside a low FODMAP diet, for a duration of 8 weeks. The study aims to measure various clinical outcomes, including inflammatory markers and disease activity scores, before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with active mild to moderate ulcerative colitis without other chronic disorders.
Not a fit: Patients with recent changes in medication or those who have experienced severe relapses requiring hospitalization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary supplement option for managing symptoms of ulcerative colitis.
How similar studies have performed: While the specific use of bromelain in ulcerative colitis is novel, other studies have explored dietary interventions for similar conditions with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tehran, Middle East
- Azita Hekmatdoost — Tehran, Middle East, Iran, Islamic Republic of (Recruiting)
Study contacts
- Principal investigator: Azita Hekmatdoost, MD, PhD — Shahid Beheshti University of Medical Sciences
- Study coordinator: Azita Hekmatdoost, MD, PhD
- Email: a_hekmat2000@yahoo.com
- Phone: +989123065084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.