The Effects of Bromelain Supplement in Patients With Ulcerative Colitis

April 6, 2024 updated by: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo (1500 mg/day)
Active Comparator: Intervention
Bromleine
Dietary supplement: Bromlein
1500 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCCAIQ
Time Frame: At the 1st day and 8th week
Simple clinical colitis activity index questionnaire (0-19, higher scores means higher symptoms)
At the 1st day and 8th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum TAC
Time Frame: At the 1st day and 8th week
serum level of total anti-oxidant capacity
At the 1st day and 8th week
Serum hsCRP
Time Frame: At the 1st day and 8th week
serum level of high sensitive C-reactive protein
At the 1st day and 8th week
Serum TNF-a
Time Frame: At the 1st day and 8th week
serum level of tumor necrosis factor-a
At the 1st day and 8th week
IBDQ
Time Frame: At the 1st day and 8th week
IBD quality of life questionnaire (9-63, higher scores mean higher quality of life)
At the 1st day and 8th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Investigators

  • Principal Investigator: Azita Hekmatdoost, MD, PhD, Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2024

Primary Completion (Estimated)

July 20, 2024

Study Completion (Estimated)

August 10, 2024

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 6, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43008563

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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