ClinicalTrials.gg
Sign In
CompletedNCT06351696Updated Oct 27, 2026

The Effects of Bromelain Supplement in Patients With Ulcerative Colitis

A Phase 2/3 interventional study of Bromlein and Placebo in Ulcerative Colitis and Primary Sclerosing Cholangitis, sponsored by National Nutrition and Food Technology Institute. Completed at 1 site in Iran. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by National Nutrition and Food Technology Institute · Phase 2/3, Interventional, and Treatment

Updated Oct 27, 2026Now CompletedPrimary completion moved+3 moreGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ulcerative Colitis
  • Primary Sclerosing Cholangitis
03

In context

Colitis, Ulcerative

1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.

This study's enrollment of 52 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

National Nutrition and Food Technology Institute is the lead sponsor of 63 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • active mild to moderate UC
  • no other chronic disorders

Exclusion criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
52 participants (actual)

Study arms

  • Active comparator
    Intervention

    Bromleine

    Dietary Supplement: Bromlein

  • Placebo comparator
    Placebo

    Placebo

    Other: Placebo

Interventions

  • Dietary supplementBromlein

    1500 mg/day

  • OtherPlacebo

    Placebo (1500 mg/day)

06

What researchers measure

Primary outcomes

  1. SCCAIQ

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

    Time frame: At the 1st day and 8th week

Secondary outcomes

  1. IBDQ

    IBD quality of life questionnaire (9-63, higher scores mean higher quality of life)

    Time frame: At the 1st day and 8th week

  2. Serum TAC

    serum level of total anti-oxidant capacity

    Time frame: At the 1st day and 8th week

  3. Serum hsCRP

    serum level of high sensitive C-reactive protein

    Time frame: At the 1st day and 8th week

  4. Serum TNF-a

    serum level of tumor necrosis factor-a

    Time frame: At the 1st day and 8th week

07

Study locations

1 site
  • Azita Hekmatdoost
    Tehran, Middle East 19835, Iran
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Apr 2024 to primary completion in May 2025, 12 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 27, 2026: primary completion Jul 2024 → May 2025 and completion Aug 2024 → May 2025.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2024
First posted
Apr 8, 2024
StartActual
Apr 20, 2024
Primary completionActual
May 10, 2025was Jul 2024
CompletionActual
May 10, 2025was Aug 2024
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 27, 2026
Primary completion
Jul 20, 2024→May 10, 2025 (actual)
Oct 27, 2026
Study completion
Aug 10, 2024→May 10, 2025 (actual)
Oct 27, 2026
Enrollment
84 (estimated)→52 (actual)
Oct 27, 2026
Design
Added Phase 2·Phase 3; removed Not applicable
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Recruiting→Completed
    Primary completion Jul 20, 2024→May 10, 2025 (now actual)
    Study completion Aug 10, 2024→May 10, 2025 (now actual)
    Enrollment 84 (estimated)→52 (actual)
    Design Added Phase 2·Phase 3; removed Not applicable
    + 4 other changes: verification date, contact details, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06351696
Lead sponsor
National Nutrition and Food Technology Institute
Responsible party
Dr Azita Hekmatdoost (Principle Investigator, National Nutrition and Food Technology Institute) — Principal investigator
First posted
Apr 8, 2024
Start date
Apr 20, 2024
Primary completion
May 10, 2025
Completion
May 10, 2025
Last update
Oct 27, 2026

Study contacts

Azita Hekmatdoost, MD, PhD
principal investigator · Shahid Beheshti University of Medical Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Colitis, Ulcerative →

Other studies from this sponsor

National Nutrition and Food Technology Institute

Start the discussion