The Effects of Bromelain Supplement in Patients With Ulce... | NCT06351696

Studies
The Effects of Bromelain Supplement in Patients With Ulcerative Colitis

NCT06351696

Sponsor

National Nutrition and Food Technology Institute

Status

Unknown status

Last Update Posted

Apr 9, 2024Actual

Enrollment

84Estimated

Phase

Not Applicable

Conditions

Ulcerative Colitis
Primary Sclerosing Cholangitis

Interventions

Bromlein
Placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 20, 2024Estimated

Primary Completion Date

Jul 20, 2024Estimated

Completion Date

Aug 10, 2024Estimated

First Submitted Date

Apr 2, 2024

First Submission Date that Met QC Criteria

Apr 5, 2024

First Posted Date

Apr 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2024

Last Update Posted Date

Apr 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Azita Hekmatdoost, Principle Investigator, National Nutrition and Food Technology InstitutePrincipal Investigator

Lead Sponsor

National Nutrition and Food Technology InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Active Comparator	Bromleine	Dietary Supplement: Bromlein
Placebo	Placebo Comparator	Placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bromlein	Dietary Supplement	1500 mg/day	Intervention
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
IBDQ	IBD quality of life questionnaire (9-63, higher scores mean higher quality of life)	At the 1st day and 8th week
Serum TAC	serum level of total anti-oxidant capacity

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Azita Hekmatdoost, MD, PhD	Contact	+989123065084		a_hekmat2000@yahoo.com
Reihaneh Samieeian, MSc	Contact	+989120037539		reyhane.samieyan@gmail.com

Overall Officials

Name	Affiliation	Role
Azita Hekmatdoost, MD, PhD	Shahid Beheshti University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azita Hekmatdoost	Recruiting	Tehran	Middle East	19835	Iran

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative
D015209	Cholangitis, Sclerosing

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided