Ulcerative ColitisPREDUCTOMENCT05579483
Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures
A study testing Prebiotics in people with Ulcerative Colitis, run by Wageningen University at 1 site in Netherlands.
Trial summary
A double-blind randomized placebo-controlled parallel trial with two intervention arms and two placebo arms and a period of eight intervention weeks to validate the prediction that prebiotics could induce a higher response in mild UC patients with certain fecal microbiome signatures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Prebiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2023to Oct 2025
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18 to 65 years
- Body Mass Index (BMI) between 18 and 30 kg/m2 (self-reported)
- Ulcerative Colitis confirmed via previous endoscopy and histology
- Mild active UC as defined by P-SCCAI score of 3 to 5 (range 0 to 19)
- Frequent relapse (at least one exacerbation in the last two years)
- No known allergy to any components of the study product (self-reported)
Show all 10Show fewer
- Signed informed consent
- Stable UC medication defined as no switch to other medication or no dose change
- Mobile phone on which apps (used for questionnaires) can be downloaded (iOS version 9 and newer, Android version 4.4 and newer. Phones manufactured after 2013 are usually suitable)
- Stable dietary pattern during the study
Who cannot join
- Any other underlying disease of the GI-tract or previous bowel surgery, except cholecystectomy and appendectomy
- Pregnancy or intending to become pregnant during the study
- Use of medication that can interfere with the study outcomes, as judged by the medical supervisor
- The need for antibiotic use during the intervention period
- Systemic antibiotics and proton pump inhibitors (except for omeprazole and pantoprazole with dosage <20 mg), prebiotic supplements, probiotic supplements four weeks prior to study start
- Currently participating in another intervention study
- Acquaintances of anyone in the research team
Trial locations and contacts
1 site in 1 country.
About this study
A double-blind randomized placebo-controlled parallel trial with two intervention arms and two placebo arms and a period of eight intervention weeks to validate the prediction that prebiotics could induce a higher response in mild UC patients with certain fecal microbiome signatures.
Read the detailed description
Rationale: Ulcerative colitis (UC) patients respond differently to treatments/interventions (e.g. diet/fecal microbiota transplantation), but the reason for this individual specificity remains unknown. The investigators hypothesize that the baseline fecal microbiota composition determines the efficacy of a treatment/intervention, and potential responders, i.e. patients showing symptoms improvement after treatment, can be predicted based on fecal microbiota composition.
Objective: The primary objective is to validate the prediction that prebiotics intervention boosts butyrate production and thereby induces a higher response (lower mean Patient Simple Clinical Colitis Activity Index (P-SCCAI) score) in mild UC patients with a more healthy like microbiota composition (predicted responders), but not in those with more aberrant microbiota composition (predicted non-responders) at T = 8 weeks. The secondary objectives are to study the effects of prebiotics intervention on disease activity over time (T = 0, 4, 8, 12 and 60 weeks), mucosal inflammation, gastro-intestinal (GI) complaints, stool consistency, stool frequency, fecal microbiota composition, fecal short-chain fatty acids concentrations, quality of life, number of participants with increased or decreased medication use, and incidence of adverse events in mild UC patients.
Study design: This study is a four-arm double-blind randomized placebo-controlled parallel trial. It consists of a screening stage in which mild UC patients will be assigned to be predicted responders or predicted non-responders based on microbiota composition. Afterwards the predicted responders and non-responders will be assigned to either the prebiotics group (arm 1 and 3) or placebo group (arm 2 and 4).
Study population: Adult subjects aged 18-65 years and body mass index 18-30 kg/m2 with mild UC defined by P-SCCAI (3-5 points in a 19-point scale), with at least one relapse in the last two years.
Intervention: An 8-week intervention period with four parallel arms: 1) predicted responders with prebiotics treatment (acacia gum, partially hydrolyzed guar gum, and resistant starch), 2) predicted responders with placebo (maltodextrin and corn starch), 3) predicted non-responders with prebiotics treatment, 4) predicted non-responders with placebo, during which the study participants consume the respective supplement (3 grams, twice daily).
Main study parameters/endpoints: The main parameter is the response (mean P-SCCAI score) between arms at T = 8 weeks. The secondary parameters are the disease activity over time at T = 0, 4, 8, 12, and 60 weeks, mucosal inflammation (fecal calprotectin), gastro-intestinal (GI) complaints, stool consistency, stool frequency, fecal microbiota composition, fecal short-chain fatty acids concentrations, health-related quality of life, number of participants with increased or decreased medication use, and incidence of adverse events.
- Conditions
- Ulcerative Colitis
- Being tested
- Prebiotics, Placebo
- Keywords
- prebiotics, ulcerative colitis, gut microbiome signature, fiber intake, prediction
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrebioticsDietary supplement
The prebiotics consists of three non-digestible carbohydrates (40% acacia gum, 20% partially hydrolyzed guar gum, and 40% resistant starch). During the 8-week intervention, two sachets (3 g per sachet) will be consumed per day, one in the morning and one in the evening.
PlaceboDietary supplement
The placebo consists of two digestible carbohydrates (20% maltodextrin and 80% corn starch). During the 8-week intervention, two sachets (3 g per sachet) will be consumed per day, one in the morning and one in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Predicted responders with prebiotics | Experimental | Predicted responders, which are defined as UC patients having a healthy like microbiome will receive 6 grams of prebiotics per day. Receives: Dietary Supplement: Prebiotics |
| Predicted responders with placebo | Placebo comparator | Predicted responders, which are defined as UC patients having a healthy like microbiome will receive 6 grams of placebo per day. Receives: Dietary Supplement: Placebo |
| Predicted non-responders with prebiotics | Experimental | Predicted non-responders, which are defined as UC patients having an aberrant microbiome will receive 6 grams of prebiotics per day. Receives: Dietary Supplement: Prebiotics |
| Predicted non-responders with placebo | Placebo comparator | Predicted non-responders, which are defined as UC patients having an aberrant microbiome, will receive 6 grams of placebo per day. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response between arms at T = 8 weeks
Within each arm, response will be determined by the mean Patient Simple Clinical Colitis Activity Index (P-SCAAI) score on a nineteen-point scale (from "0: no symptoms" to "19: severest symptom"). It refers to disease activity during the previous week, with higher scores representing worse disease symptoms.
Measured: Response at the end the intervention (T= 8 weeks)
Secondary outcomes (10)
Disease activity over time (T= 0, 4, 8, 12, and 60 weeks)
Disease activity will be determined by the Patient Simple Clinical Colitis Activity Index (P-SCAAI) score on a nineteen-point scale (from "0: no symptoms" to "19: severest symptom"). With P-SCCAI score <= 2 being regarded as clinical remission, and a decrease in the P-SCCAI score by more than two points from baseline being regarded as clinical response. Comparisons will be made between groups as well as within subjects over time.
Measured: Disease activity during and after the intervention (at T= 0, 4, 8, 12, and 60 weeks)
Mucosal inflammation
Mucosal inflammation will be determined by the fecal calprotectin level, which is a biomarker of inflammation and disease activity.
Measured: Change during and after the intervention (at T= 0, 8, 12, and 60 weeks)
GI complaints
The GI complaints will be assessed by the (gastrointestinal symptom rating scale) GSRS questionnaire, which has a seven-point graded scale where 1 represents the absence of troublesome symptoms and 7 represents very troublesome symptoms.
Measured: Change during the intervention (at T= 0, 4, and 8 weeks)
Stool consistency
Stool consistency will be measured using the Bristol Stool Form Scale (7-point scale from 1=hard to 7=diarrhea) on a daily basis for 7 days
Measured: Change during the intervention (at T= 0, 4, and 8 weeks)
Stool frequency
Stool frequency will be measured by counting number of defecation on a daily basis for 7 days.
Measured: Change during the intervention (at T= 0, 4, and 8 weeks)]
Fecal microbiota composition
Fecal microbiota composition will be determined by 16S rRNA gene sequencing.
Measured: Change during and after the intervention (at T= 0, 8, 12, and 60 weeks)
Fecal short-chain fatty acids concentrations
Fecal short-chain fatty acids concentrations will be determined by HPLC.
Measured: Change during and after the intervention (at T= 0, 8, 12, and 60 weeks)
Health-related quality of life
Health-related quality of life will be assessed by short inflammatory bowel disease questionnaire (SIBDQ) with a seven-point graded scale where 1 represents very troublesome symptoms and 7 represents the absence of troublesome symptoms.
Measured: Change during the intervention (at T= 0, 4, and 8 weeks)
Number of participants with increased or decreased medication use
It consists of the current medication use (e.g., aminosalicylates, corticosteroids, immunosuppressive agents, antimicrobial agents, and inhibitors of tumour necrosis factor-alpha (TNF- α)) with a downgrade meaning improvement and an upgrade meaning worsening of UC.
Measured: Change during and after the intervention (at T= 0, 4, 8, 12, and 60 weeks)
Incidence of adverse events
Incidence of adverse events will be monitored by patient record and diary, these include all relapse-relevant information, including the need for systemic steroids, hospitalization, and surgery.
Measured: Change during the intervention (at T= 0, 4, and 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study startDec 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, placebo-controlled, parallel, double-blind trial with two intervention arms and two control (placebo) arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- Winclove Probiotics B.V., China Scholarship Council
- Responsible party
- Principal investigator, Erwin Zoetendal, Wageningen University
- Investigators
- Erwin G Zoetendal, PhD, Principal investigator, Laboratory of Microbiology, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579483
- Sponsor's protocol ID
- NL79442.091.22
- Other IDs
- NL79442.091.22
- Acronym
- PREDUCTOME
- Status last verified
- Aug 2026
- First submitted
- 4 Oct 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As the data contains sensitive personal information researchers interested in the data can contact the principal investigator.
Publications
Liu Z, de Vries B, Gerritsen J, Smidt H, Zoetendal EG. Microbiome-based stratification to guide dietary interventions to improve human health. Nutr Res. 2020 Oct;82:1-10. doi: 10.1016/j.nutres.2020.07.004. Epub 2020 Jul 21.
PubMed 32889252
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome Signatures
- ClinicalTrials.gov ID
- NCT05579483
- Acronym / sponsor ID
- PREDUCTOME / NL79442.091.22
- Conditions
- Ulcerative Colitis
- Keywords
- prebiotics, ulcerative colitis, gut microbiome signature, fiber intake, prediction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- Winclove Probiotics B.V., China Scholarship Council
- Study start
- Dec 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 13 Oct 2022 (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.
A double-blind randomized placebo-controlled parallel trial with two intervention arms and two placebo arms and a period of eight intervention weeks to validate the prediction that prebiotics could induce a higher response in mild UC patients with certain fecal microbiome signatures.
Detailed description
Rationale: Ulcerative colitis (UC) patients respond differently to treatments/interventions (e.g. diet/fecal microbiota transplantation), but the reason for this individual specificity remains unknown. The investigators hypothesize that the baseline fecal microbiota composition determines the efficacy of a treatment/intervention, and potential responders, i.e. patients showing symptoms improvement after treatment, can be predicted based on fecal microbiota composition.
Objective: The primary objective is to validate the prediction that prebiotics intervention boosts butyrate production and thereby induces a higher response (lower mean Patient Simple Clinical Colitis Activity Index (P-SCCAI) score) in mild UC patients with a more healthy like microbiota composition (predicted responders), but not in those with more aberrant microbiota composition (predicted non-responders) at T = 8 weeks. The secondary objectives are to study the effects of prebiotics intervention on disease activity over time (T = 0, 4, 8, 12 and 60 weeks), mucosal inflammation, gastro-intestinal (GI) complaints, stool consistency, stool frequency, fecal microbiota composition, fecal short-chain fatty acids concentrations, quality of life, number of participants with increased or decreased medication use, and incidence of adverse events in mild UC patients.
Study design: This study is a four-arm double-blind randomized placebo-controlled parallel trial. It consists of a screening stage in which mild UC patients will be assigned to be predicted responders or predicted non-responders based on microbiota composition. Afterwards the predicted responders and non-responders will be assigned to either the prebiotics group (arm 1 and 3) or placebo group (arm 2 and 4).
Study population: Adult subjects aged 18-65 years and body mass index 18-30 kg/m2 with mild UC defined by P-SCCAI (3-5 points in a 19-point scale), with at least one relapse in the last two years.
Intervention: An 8-week intervention period with four parallel arms: 1) predicted responders with prebiotics treatment (acacia gum, partially hydrolyzed guar gum, and resistant starch), 2) predicted responders with placebo (maltodextrin and corn starch), 3) predicted non-responders with prebiotics treatment, 4) predicted non-responders with placebo, during which the study participants consume the respective supplement (3 grams, twice daily).
Main study parameters/endpoints: The main parameter is the response (mean P-SCCAI score) between arms at T = 8 weeks. The secondary parameters are the disease activity over time at T = 0, 4, 8, 12, and 60 weeks, mucosal inflammation (fecal calprotectin), gastro-intestinal (GI) complaints, stool consistency, stool frequency, fecal microbiota composition, fecal short-chain fatty acids concentrations, health-related quality of life, number of participants with increased or decreased medication use, and incidence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A randomized, placebo-controlled, parallel, double-blind trial with two intervention arms and two control (placebo) arms.
| Arm | Type | Receives |
|---|---|---|
| Predicted responders with prebiotics | Experimental | Dietary Supplement: PrebioticsPredicted responders, which are defined as UC patients having a healthy like microbiome will receive 6 grams of prebiotics per day. |
| Predicted responders with placebo | Placebo comparator | Dietary Supplement: PlaceboPredicted responders, which are defined as UC patients having a healthy like microbiome will receive 6 grams of placebo per day. |
| Predicted non-responders with prebiotics | Experimental | Dietary Supplement: PrebioticsPredicted non-responders, which are defined as UC patients having an aberrant microbiome will receive 6 grams of prebiotics per day. |
| Predicted non-responders with placebo | Placebo comparator | Dietary Supplement: PlaceboPredicted non-responders, which are defined as UC patients having an aberrant microbiome, will receive 6 grams of placebo per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male and female subjects aged 18 to 65 years
- Body Mass Index (BMI) between 18 and 30 kg/m2 (self-reported)
- Ulcerative Colitis confirmed via previous endoscopy and histology
- Mild active UC as defined by P-SCCAI score of 3 to 5 (range 0 to 19)
- Frequent relapse (at least one exacerbation in the last two years)
Key exclusion criteria (7 listed)
- Any other underlying disease of the GI-tract or previous bowel surgery, except cholecystectomy and appendectomy
- Pregnancy or intending to become pregnant during the study
- Use of medication that can interfere with the study outcomes, as judged by the medical supervisor
- The need for antibiotic use during the intervention period
- Systemic antibiotics and proton pump inhibitors (except for omeprazole and pantoprazole with dosage <20 mg), prebiotic supplements, probiotic supplements four weeks prior to study start
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 |
|---|---|---|
| PrebioticsThe prebiotics consists of three non-digestible carbohydrates (40% acacia gum, 20% partially hydrolyzed guar gum, and 40% resistant starch). During the 8-week intervention, two sachets (3 g per sachet) will be consumed per day, one in the morning and one in the evening. | Dietary supplement | Predicted non-responders with prebiotics, Predicted responders with prebiotics |
| PlaceboThe placebo consists of two digestible carbohydrates (20% maltodextrin and 80% corn starch). During the 8-week intervention, two sachets (3 g per sachet) will be consumed per day, one in the morning and one in the evening. | Dietary supplement | Predicted non-responders with placebo, Predicted responders with placebo |
Primary outcome
Response between arms at T = 8 weeks
Time frame: Response at the end the intervention (T= 8 weeks)
Within each arm, response will be determined by the mean Patient Simple Clinical Colitis Activity Index (P-SCAAI) score on a nineteen-point scale (from "0: no symptoms" to "19: severest symptom"). It refers to disease activity during the previous week, with higher scores representing worse disease symptoms.
10 secondary outcomes
Disease activity over time (T= 0, 4, 8, 12, and 60 weeks)
Time frame: Disease activity during and after the intervention (at T= 0, 4, 8, 12, and 60 weeks)
Mucosal inflammation
Time frame: Change during and after the intervention (at T= 0, 8, 12, and 60 weeks)
GI complaints
Time frame: Change during the intervention (at T= 0, 4, and 8 weeks)
Stool consistency
Time frame: Change during the intervention (at T= 0, 4, and 8 weeks)
Stool frequency
Time frame: Change during the intervention (at T= 0, 4, and 8 weeks)]
Fecal microbiota composition
Time frame: Change during and after the intervention (at T= 0, 8, 12, and 60 weeks)
Fecal short-chain fatty acids concentrations
Time frame: Change during and after the intervention (at T= 0, 8, 12, and 60 weeks)
Health-related quality of life
Time frame: Change during the intervention (at T= 0, 4, and 8 weeks)
Number of participants with increased or decreased medication use
Time frame: Change during and after the intervention (at T= 0, 4, 8, 12, and 60 weeks)
Incidence of adverse events
Time frame: Change during the intervention (at T= 0, 4, and 8 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 32889252Liu Z, de Vries B, Gerritsen J, Smidt H, Zoetendal EG. Microbiome-based stratification to guide dietary interventions to improve human health. Nutr Res. 2020 Oct;82:1-10. doi: 10.1016/j.nutres.2020.07.004. Epub 2020 Jul 21.
- Individual participant dataSharing planned: No. As the data contains sensitive personal information researchers interested in the data can contact the principal investigator.
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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.
Erwin G Zoetendal, PhD principal investigator
Laboratory of Microbiology, Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotics in people with Ulcerative Colitis, run by Wageningen University at 1 site in Netherlands.
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 10 inclusion and 7 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: withdrawn, as of the sponsor's last update on 20 Aug 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 Netherlands. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Response between arms at T = 8 weeks (time frame: Response at the end the intervention (T= 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05579483, which also lists 1 linked publication.
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 20 Aug 2026.