NCT06351696

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

April 20, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

April 2, 2024

Last Update Submit

April 6, 2024

Conditions

Ulcerative ColitisPrimary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (1)

  • SCCAIQ

    Simple clinical colitis activity index questionnaire (0-19, higher scores means higher symptoms)

    At the 1st day and 8th week

Secondary Outcomes (4)

  • IBDQ

    At the 1st day and 8th week

  • Serum TAC

    At the 1st day and 8th week

  • Serum hsCRP

    At the 1st day and 8th week

  • Serum TNF-a

    At the 1st day and 8th week

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Bromleine

Dietary Supplement: Bromlein

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

BromleinDIETARY_SUPPLEMENT

1500 mg/day

Intervention
PlaceboOTHER

Placebo (1500 mg/day)

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • active mild to moderate UC
  • no other chronic disorders

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azita Hekmatdoost

Tehran, Middle East, 19835, Iran

RECRUITING

MeSH Terms

Conditions

Colitis, UlcerativeCholangitis, Sclerosing

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal DiseasesCholangitisBile Duct DiseasesBiliary Tract Diseases

Study Officials

  • Azita Hekmatdoost, MD, PhD

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Azita Hekmatdoost, MD, PhD

CONTACT

+989123065084a_hekmat2000@yahoo.com

Reihaneh Samieeian, MSc

CONTACT

+989120037539reyhane.samieyan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 2, 2024

First Posted

April 8, 2024

Study Start

April 20, 2024

Primary Completion

July 20, 2024

Study Completion

August 10, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Locations

IR(1)