Ulcerative ColitisPhase 2/3NCT06351696
The Effects of Bromelain Supplement in Patients With Ulcerative Colitis
A Phase 2/3 study testing Bromlein in people with Ulcerative Colitis and Primary Sclerosing Cholangitis, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis, Primary Sclerosing Cholangitis
- What is being tested?
- Bromlein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteIran
- Study dates
- 20 Apr 2024to 10 May 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- active mild to moderate UC
- no other chronic disorders
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Ulcerative Colitis, Primary Sclerosing Cholangitis
- Being tested
- Bromlein, Placebo
- Medical subject headings
- Colitis, Ulcerative, Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BromleinDietary supplement
1500 mg/day
PlaceboOther
Placebo (1500 mg/day)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Bromleine Receives: Dietary Supplement: Bromlein |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCCAIQ
Simple clinical colitis activity index questionnaire (0-19, higher scores means higher symptoms)
Measured: At the 1st day and 8th week
Secondary outcomes (4)
IBDQ
IBD quality of life questionnaire (9-63, higher scores mean higher quality of life)
Measured: At the 1st day and 8th week
Serum TAC
serum level of total anti-oxidant capacity
Measured: At the 1st day and 8th week
Serum hsCRP
serum level of high sensitive C-reactive protein
Measured: At the 1st day and 8th week
Serum TNF-a
serum level of tumor necrosis factor-a
Measured: At the 1st day and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start20 Apr 2024
- Primary completion10 May 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
- Investigators
- Azita Hekmatdoost, MD, PhD, Principal investigator, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351696
- Sponsor's protocol ID
- 43008563
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06351696
- Acronym / sponsor ID
- 43008563
- Conditions
- Ulcerative Colitis, Primary Sclerosing Cholangitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Dietary Supplement: BromleinBromleine |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- active mild to moderate UC
- no other chronic disorders
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bromlein1500 mg/day | Dietary supplement | Intervention |
| PlaceboPlacebo (1500 mg/day) | Other | Placebo |
Primary outcome
SCCAIQ
Time frame: At the 1st day and 8th week
Simple clinical colitis activity index questionnaire (0-19, higher scores means higher symptoms)
4 secondary outcomes
IBDQ
Time frame: At the 1st day and 8th week
Serum TAC
Time frame: At the 1st day and 8th week
Serum hsCRP
Time frame: At the 1st day and 8th week
Serum TNF-a
Time frame: At the 1st day and 8th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Azita Hekmatdoost, MD, PhD principal investigator
Shahid Beheshti University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bromlein in people with Ulcerative Colitis and Primary Sclerosing Cholangitis, run by National Nutrition and Food Technology Institute at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCCAIQ (time frame: At the 1st day and 8th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.