The Effects of Bromelain Supplement in Patients With Ulcerative Colitis

NCT ID: NCT06351696

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-20

Study Completion Date

2024-08-10

Brief Summary

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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

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Conditions

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Ulcerative Colitis Primary Sclerosing Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

Bromleine

Group Type ACTIVE_COMPARATOR

Bromlein

Intervention Type DIETARY_SUPPLEMENT

1500 mg/day

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo (1500 mg/day)

Interventions

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Bromlein

1500 mg/day

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (1500 mg/day)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Dr Azita Hekmatdoost

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Azita Hekmatdoost, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shahid Beheshti University of Medical Sciences

Locations

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Azita Hekmatdoost

Tehran, Middle East, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Azita Hekmatdoost, MD, PhD

Role: CONTACT

+989123065084

Reihaneh Samieeian, MSc

Role: CONTACT

+989120037539

Facility Contacts

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Azita Hekmatdoost, MD, PhD

Role: primary

+989123065084

Other Identifiers

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43008563

Identifier Type: -

Identifier Source: org_study_id

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