Crohn Disease · Ulcerative Colitis
Prebiotic Supplement Timing in Adults With Active Ulcerative Colitis
This study is examining how eight weeks of daily prebiotic supplementation affects gut microbes, intestinal inflammation, and symptoms in adults with active, biopsy-confirmed ulcerative colitis.
Registry title: Impact of Prebiotics in Ulcerative Colitis
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–85 Years
- Treatment
- Prebiotic
- Design
- Randomized · Double
- Sponsor
- University of California, Los Angeles
Research question
How does the timing of an eight-week course of daily prebiotic supplementation relate to changes in gut microbial composition, intestinal inflammation, and ulcerative colitis symptoms over 16 weeks?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 85.
- The study is looking for people with a history of biopsy-proven ulcerative colitis.
- The study is looking for people with active symptoms, defined as a Simple Colitis Clinical Activity Index score above 2.
- The listed recruiting site is UCLA in Los Angeles, California.
Participation overview
What participation may involve
Participation is described over 16 weeks. Participants take a daily prebiotic supplement for eight weeks beginning at week 0 or week 8, have diet assessed, and provide stool samples for inflammation and microbial analyses. What participation may involve: - Take a daily dose of the prebiotic supplement for eight weeks. - Have dietary composition assessed at baseline and during the 16-week study period. - Provide stool samples at weeks 0 and 8. - Have ulcerative colitis symptoms assessed using the Simple Colitis Clinical Activity Index. - Have stool evaluated for fecal calprotectin, a measure of intestinal inflammation, and for microbial composition. The registry describes dietary assessment and study outcomes over 16 weeks, including an eight-week course of prebiotic supplementation.
Study interventions
What participants may receive or do
- Prebiotic: Participants are asked to take a daily dose of a prebiotic supplement for eight weeks, beginning either at week 0 or week 8 according to study assignment.
Study design
How the comparison works
This is a randomized, parallel-group study comparing two start times for the same eight-week prebiotic course: week 0 or week 8. The investigator and outcomes assessor are masked to assignments. Participants are randomly assigned to begin the prebiotic supplement at week 0 or week 8. The registry describes double masking: the investigator and outcomes assessor will not know participants' assignments. The comparison group receives the same prebiotic course starting at week 8 rather than week 0.
Reported activities
Procedures and tests
- Dietary composition assessment at baseline and during the 16-week study period.
- Stool sample collection at weeks 0 and 8.
- Simple Colitis Clinical Activity Index assessment, scored from 0 to 20 with higher scores indicating greater severity.
- Fecal calprotectin testing to measure intestinal inflammation.
- Stool microbial analysis measuring and characterizing the relative quantities of microbial genera and species.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 18 through 85 years old.
- Participants must have a history of ulcerative colitis confirmed by biopsy.
- Participants must have active symptoms, defined as a Simple Colitis Clinical Activity Index score above 2.
- Use of 5-aminosalicylates, immunomodulators, or corticosteroids is permitted, but these treatments must not have been started or dose-adjusted within 30 days before enrollment.
- Biologic therapy is permitted, but it must not have been started or dose-adjusted within 60 days before enrollment.
- Previous probiotic or other dietary supplement use is permitted, but participants will be asked to stop these products during the trial.
Possible reasons someone may not be able to join
- People who have previously had a colectomy are excluded.
- People who are hospitalized are excluded.
- People with an urgent need for abdominal surgery are excluded.
- People with an unstable major medical condition are excluded.
- People with an active malignancy that is under treatment are excluded.
- People with active alcohol or non-cannabinoid substance abuse are excluded.
- People who are pregnant or lactating are excluded.
- The study excludes people when the study team has concerns about their ability to follow study requirements.
Important unknowns
What the record does not make clear
- The registry reports assessment and stool-sampling time points but does not state the number, format, or length of study visits.
- Several ulcerative colitis treatments are permitted if stable before enrollment, but the registry does not say whether they must remain unchanged throughout the study.
- The registry says prior probiotics and other dietary supplements must be discontinued during the trial but does not state when they must be stopped.
- The registry does not describe treatment options if ulcerative colitis symptoms worsen during the study.
- The registry requires a history of biopsy-proven ulcerative colitis but does not report whether endoscopy or another biopsy is required for this study.
- The registry does not explain which study-related or routine-care costs are covered or billed to insurance.
- The registry does not state whether participants receive compensation.
- The registry does not state whether transportation, parking, lodging, or other travel support is available.
- The registry does not say whether any assessments can be completed remotely or whether stool samples can be collected at home and shipped.
- The conditions module lists both Crohn disease and ulcerative colitis, while the eligibility criteria specifically require biopsy-proven ulcerative colitis.
Before contacting the site
Questions for the study team
- How many study visits are required, which must be in person, and how long does each usually take?
- What is in the prebiotic supplement, what daily dose is used, and how is it taken?
- Which ulcerative colitis medicines may continue, and must they stay at the same dose throughout the study?
- Which probiotics or dietary supplements must be stopped, and when must they be discontinued?
- What happens if symptoms worsen, and what rescue treatment is allowed?
- Are endoscopy or a new biopsy required for screening or participation?
- Is enrollment limited to ulcerative colitis, or is there also a Crohn disease cohort?
- Which costs are covered, is compensation offered, and is travel or parking support available?
Before changing care
Questions for your gastroenterologist
- Would my ulcerative colitis be considered stable enough to discuss this study with the research team?
- How could the study's medication-stability rules affect my current treatment plan?
- What approved treatment alternatives should I consider while learning more about this study?
- Are there clinical concerns for me with taking a prebiotic supplement or stopping my current probiotics and dietary supplements?
- How should my gastroenterology care be coordinated with the research team if my symptoms or inflammation worsen?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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 and administration
- Organization
- University of California, Los Angeles
- Organization class
- Other
- Organization study ID
- 24-000256
- Lead sponsor
- University of California, Los Angeles
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Other
- Masking
- Double
- Who is masked
- Investigator, Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study arms
Experimental
Prebiotic at Week 0
Interventions: Dietary Supplement: Prebiotic
Active Comparator
Prebiotic at Week 8
Interventions: Dietary Supplement: Prebiotic
Interventions
Dietary Supplement
Prebiotic
Participants will be asked to take a daily dose of prebiotic supplement for 8 weeks.
Eligibility
18 Years–85 Years
All
Not accepted
Inclusion criteria (6)
- Ages 18 to 85 years oldRegistry-derived · unreviewed
- History of biopsy-proven ulcerative colitis (UC)Registry-derived · unreviewed
- Active symptoms (SCCAI \>2)Registry-derived · unreviewed
- 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.Registry-derived · unreviewed
- Concomitant use of biologic therapy will be permitted, although initiation or dose adjustment must not have occurred within 60 days prior to enrollment.Registry-derived · unreviewed
- Prior probiotics or other dietary supplements use is permitted but will be asked to be discontinued during the course of the trialRegistry-derived · unreviewed
Exclusion criteria (8)
- Prior colectomyRegistry-derived · unreviewed
- HospitalizationRegistry-derived · unreviewed
- Urgent need for abdominal surgeryRegistry-derived · unreviewed
- Unstable major medical conditionRegistry-derived · unreviewed
- Active malignancy under treatmentRegistry-derived · unreviewed
- Active alcohol or non-cannabinoid substance abuseRegistry-derived · unreviewed
- Pregnancy or lactationRegistry-derived · unreviewed
- Concerns for non-complianceRegistry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
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).
Primary outcome
Change in fecal calprotectin
Time frame: Week 8
Fecal calprotectin is a stool test that measures intestinal inflammation
Primary outcome
Microbial composition
Time frame: Week 8
Microbial composition includes a measurement and characterization of the relative quantity of genera and species.
Secondary outcome
Clinical response
Time frame: Week 8
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).
Secondary outcome
Clinical remission
Time frame: Week 16
Clinical remission will be defined as a Simple Colitis Clinical Activity Index (SCCAI) \< 4. Range of SCCAI is 0-20 (higher is more severe).
Secondary outcome
Clinical response
Time frame: Week 16
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).
Secondary outcome
Change in fecal calprotectin
Time frame: Week 16
Fecal calprotectin is a stool test that measures intestinal inflammation
Secondary outcome
Microbial composition
Time frame: Week 16
Microbial composition includes a measurement and characterization of the relative quantity of genera and species.
Recruiting locations in the United States
UCLA
RecruitingLos Angeles, California, 90095, United States
Berkeley Limketkai, MD, PhD8554238252berkeley.limketkai@gmail.com
Registry dates
- First posted
- Jul 11, 2024
- Primary completion
- Dec 31, 2026
- Overall completion
- Dec 31, 2027
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.