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NCT06351696 Clinical Trial

The Effects of Bromelain Supplement in Patients With Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06351696
Other study ID # 43008563
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 20, 2024
Est. completion date August 10, 2024

Study information
Verified date April 2024
Source National Nutrition and Food Technology Institute
Contact Azita Hekmatdoost, MD, PhD
Phone +989123065084
Email a_hekmat2000@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 84
Est. completion date August 10, 2024
Est. primary completion date July 20, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Bromlein
1500 mg/day
Other:
• Placebo
Placebo (1500 mg/day)

Locations
Country Name City State
Iran, Islamic Republic of Azita Hekmatdoost Tehran Middle East

Sponsors (1)
Lead Sponsor Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary SCCAIQ Simple clinical colitis activity index questionnaire (0-19, higher scores means higher symptoms) At the 1st day and 8th week
Secondary IBDQ IBD quality of life questionnaire (9-63, higher scores mean higher quality of life) At the 1st day and 8th week
Secondary Serum TAC serum level of total anti-oxidant capacity At the 1st day and 8th week
Secondary Serum hsCRP serum level of high sensitive C-reactive protein At the 1st day and 8th week
Secondary Serum TNF-a serum level of tumor necrosis factor-a At the 1st day and 8th week
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