Crohn DiseaseNCT06495658
Impact of Prebiotics in Ulcerative Colitis
A study testing Prebiotic in people with Crohn Disease and Ulcerative Colitis, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The cause of inflammatory bowel disease (IBD) is currently unknown, although partly attributed to interactions among genetic risk polymorphisms, environmental factors, gut microbiome, and host immunity. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis
- What is being tested?
- Prebiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 to 85 years old
- History of biopsy-proven ulcerative colitis (UC)
- Active symptoms (SCCAI >2)
- Concomitant use of 5-aminosalicylates, immunomodulators, and corticosteroids will be permitted, although initiation or dose adjustment must not have occurred within 30 days prior to enrollment.
- Concomitant use of biologic therapy will be permitted, although initiation or dose adjustment must not have occurred within 60 days prior to enrollment.
- Prior probiotics or other dietary supplements use is permitted but will be asked to be discontinued during the course of the trial
Who cannot join
- Prior colectomy
- Hospitalization
- Urgent need for abdominal surgery
- Unstable major medical condition
- Active malignancy under treatment
- Active alcohol or non-cannabinoid substance abuse
- Pregnancy or lactation
- Concerns for non-compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCLA
Los Angeles, California, 90095
Berkeley Limketkai, MD, PhD, 8554238252, berkeley.limketkai@gmail.com
About this study
Official title: The Clinical and Microbial Impact of Prebiotics in Ulcerative Colitis
The cause of inflammatory bowel disease (IBD) is currently unknown, although partly attributed to interactions among genetic risk polymorphisms, environmental factors, gut microbiome, and host immunity. Diet, particularly those with plant-based products, have been shown in prior research to improve gut microbial composition, which has been linked to different IBD-related outcomes. This study is interested in evaluating the impact of prebiotics on gut microbiome composition and gut health in patients with IBD.
Dietary composition will be assessed at baseline and over the course of 16 weeks. Participants will be randomized to either consume an 8-week course of prebiotic supplementation beginning at week 0 or week 8. Stool samples will be collected at weeks 0 and 8. The stool will be analyzed for cross-sectional and longitudinal fecal microbial changes associated with different prebiotic and diet consumption patterns in the context of heterogeneous disease characteristics.
- Conditions
- Crohn Disease, Ulcerative Colitis
- Being tested
- Prebiotic
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticDietary supplement
Participants will be asked to take a daily dose of prebiotic supplement for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic at Week 0 | Experimental | Not described Receives: Dietary Supplement: Prebiotic |
| Prebiotic at Week 8 | Active comparator | Not described Receives: Dietary Supplement: Prebiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission
Clinical remission will be defined as a Simple Colitis Clinical Activity Index (SCCAI) < 4. Range of SCCAI is 0-20 (higher is more severe).
Measured: Week 8
Change in fecal calprotectin
Fecal calprotectin is a stool test that measures intestinal inflammation
Measured: Week 8
Microbial composition
Microbial composition includes a measurement and characterization of the relative quantity of genera and species.
Measured: Week 8
Secondary outcomes (5)
Clinical response
Clinical response will be defined as a reduction of Simple Colitis Clinical Activity Index (SCCAI). Range of SCCAI is 0-20 (higher is more severe).
Measured: Week 8
Clinical remission
Clinical remission will be defined as a Simple Colitis Clinical Activity Index (SCCAI) < 4. Range of SCCAI is 0-20 (higher is more severe).
Measured: Week 16
Clinical response
Clinical response will be defined as a reduction of Simple Colitis Clinical Activity Index (SCCAI). Range of SCCAI is 0-20 (higher is more severe).
Measured: Week 16
Change in fecal calprotectin
Fecal calprotectin is a stool test that measures intestinal inflammation
Measured: Week 16
Microbial composition
Microbial composition includes a measurement and characterization of the relative quantity of genera and species.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start9 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berkeley Limketkai, MD, PhD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495658
- Sponsor's protocol ID
- 24-000256
- Status last verified
- Dec 2025
- First submitted
- 3 Apr 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Microbial Impact of Prebiotics in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06495658
- Acronym / sponsor ID
- 24-000256
- Conditions
- Crohn Disease, Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Jul 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.
The cause of inflammatory bowel disease (IBD) is currently unknown, although partly attributed to interactions among genetic risk polymorphisms, environmental factors, gut microbiome, and host immunity. Diet, particularly those with plant-based products, have been shown in prior research to improve gut microbial composition, which has been linked to different IBD-related outcomes. This study is interested in evaluating the impact of prebiotics on gut microbiome composition and gut health in patients with IBD.
Dietary composition will be assessed at baseline and over the course of 16 weeks. Participants will be randomized to either consume an 8-week course of prebiotic supplementation beginning at week 0 or week 8. Stool samples will be collected at weeks 0 and 8. The stool will be analyzed for cross-sectional and longitudinal fecal microbial changes associated with different prebiotic and diet consumption patterns in the context of heterogeneous disease characteristics.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic at Week 0 | Experimental | Dietary Supplement: Prebiotic |
| Prebiotic at Week 8 | Active comparator | Dietary Supplement: Prebiotic |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 18 to 85 years old
- History of biopsy-proven ulcerative colitis (UC)
- Active symptoms (SCCAI >2)
- Concomitant use of 5-aminosalicylates, immunomodulators, and corticosteroids will be permitted, although initiation or dose adjustment must not have occurred within 30 days prior to enrollment.
- Concomitant use of biologic therapy will be permitted, although initiation or dose adjustment must not have occurred within 60 days prior to enrollment.
Key exclusion criteria (8 listed)
- Prior colectomy
- Hospitalization
- Urgent need for abdominal surgery
- Unstable major medical condition
- Active malignancy under treatment
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 |
|---|---|---|
| PrebioticParticipants will be asked to take a daily dose of prebiotic supplement for 8 weeks. | Dietary supplement | Prebiotic at Week 0, Prebiotic at Week 8 |
Primary outcome
Clinical remission
Time frame: Week 8
Clinical remission will be defined as a Simple Colitis Clinical Activity Index (SCCAI) < 4. Range of SCCAI is 0-20 (higher is more severe).
Change in fecal calprotectin
Time frame: Week 8
Fecal calprotectin is a stool test that measures intestinal inflammation
Microbial composition
Time frame: Week 8
Microbial composition includes a measurement and characterization of the relative quantity of genera and species.
5 secondary outcomes
Clinical response
Time frame: Week 8
Clinical remission
Time frame: Week 16
Clinical response
Time frame: Week 16
Change in fecal calprotectin
Time frame: Week 16
Microbial composition
Time frame: Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic in people with Crohn Disease and Ulcerative Colitis, run by University of California, Los Angeles at 1 site in United States.
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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Feb 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission (time frame: Week 8). The study lists 3 primary outcomes in all. 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 Feb 2026.