Ulcerative ColitisEarly Phase 1NCT03309865
Evaluating the Combined Effect of Vedolizumab and Semi-Vegetarian Diet on Ulcerative Colitis.
A Early Phase 1 study testing semi-vegetarian diet and Vedolizumab Injection in people with Ulcerative Colitis and Dietary Modification, run by Mayo Clinic at 1 site in United States.
Trial summary
Research of fecal microflora and dysbiosis status in ulcerative colitis (UC) has shown its influential role on the disease pathogenesis. Vedolizumab, a humanized monoclonal antibody blocking the migration of leukocytes into inflamed intestinal tissue, has been shown to achieve remission in about half of active UC… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Dietary Modification
- What is being tested?
- semi-vegetarian diet and Vedolizumab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Dec 2017to 31 Dec 2018
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- diagnosed with active UC (with a Mayo score ≥4, with an endoscopic Mayo Clinic score ≥1, and disease that extended 15 cm or more from the anal verge)
- failed with prior mesalamine therapy
- Patients who were previously exposed to mesalamine or steroids will have a 30-day washout period before being enrolled
- Patients who were previously exposed to tumor necrosis factor (TNF) antagonists will have a 60-day washout period before being enrolled
- For patients who were previously exposed to glucocorticoids, immunosuppressive medications (i.e., azathioprine, 6-mercaptopurine, or methotrexate), or TNF antagonists, a documentation of unsuccessful previous treatment (i.e., lack of response or unacceptable adverse events) is required
- A diagnosis of UC confirmed by biopsy obtained at the index colonoscopy or flexible sigmoidoscopy.
Who cannot join
- Patients who have been on semi-vegetarian diet before the trial will be excluded
- pregnancy or lactation
- an unstable or uncontrolled medical disorder
- an anticipated requirement for major surgery
- history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC, or planned bowel surgery
- unable to give informed consent
Show all 22Show fewer
- current diagnosis of fulminant colitis or toxic megacolon, abdominal abscess, symptomatic colonic stricture, stoma
- disease limited to the rectum (ulcerative proctitis)
- current total parenteral nutrition
- positive Clostridium difficile stool assay
- history of an infection requiring intravenous antimicrobial therapy within 1 month or oral antimicrobial therapy within 2 weeks
- history of listeria, histoplasmosis, chronic or active hepatitis B or C infection, human immunodeficiency virus, immunodeficiency syndrome, untreated tuberculosis
- history of central nervous system demyelinating disease
- history of malignancy other than a successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix, or evidence of dysplasia or malignancy on the screening colonoscopy/flexible sigmoidoscopy with biopsy
- Any of the following laboratory abnormalities during the screening period:
- Hemoglobin level <8 g/dL
- WBC count <3 × 109/L
- Lymphocyte count <0.5 × 109/L
- Platelet count <100k/L or >1200k/L
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal (ULN)
- Alkaline phosphatase >3 × ULN, g) Serum creatinine >2 × ULN
- Antibiotic use within past 14 days; Probiotics use within past 7 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Evaluating the Synergistic Effect of Vedolizumab in Conjunction With Structured Semi-Vegetarian Diet on the Treatment of Ulcerative Colitis.
Research of fecal microflora and dysbiosis status in ulcerative colitis (UC) has shown its influential role on the disease pathogenesis. Vedolizumab, a humanized monoclonal antibody blocking the migration of leukocytes into inflamed intestinal tissue, has been shown to achieve remission in about half of active UC patients. Dietary intervention in UC patients has not been adequately studied. There is a significant clinical gap to achieve a higher efficacy and better clinical outcomes on the treatment of active UC patients. This study proposes to assess the integrated effect of normalization of intestinal dysbiosis through a structured semi-vegetarian dietary intervention in active UC patients who will also be under the standard of care medical therapy (vedolizumab).
Significance of investigation for innovation: The pathogenesis of UC has been found to be multi-factorial, including host genetics and dysregulated inflammatory response, and recent research has shown the influential role of gut environmental factors - dysbiosis which has been found the key feature of UC. Vedolizumab has been shown effective (e.g. 47% clinical response rate vs. 25% in placebo group) and is part of the current standard of care treatment in UC. With the observation of drastic increase of IBD patients in Asia, in which has historically low incidence of IBD, it is generally accepted that the westernized diet and urbanization of life style play an important role in IBD pathogenesis. Enteral nutritional therapy has been demonstrated effective in pediatric Crohn's disease (CD) patients; however, the application to adult IBD patients has not been widely accepted partly because of the compliance issue. In addition, unlike CD, neither enteral nutrition nor non-enteral nutrition in patients with active UC has been adequately studied. Therefore, this study proposes a novel approach to assess the integrated effect of a structured dietary intervention in active UC patients who will also be under the current standard of care medical therapy (vedolizumab). After this study achieves the proposed primary or secondary outcome, it will further support the hypothesized synergistic interactive therapeutic effect between the normalization of dysbiosis in the intestine (through dietary intervention) and anti-inflammatory biologics (vedolizumab).
Read the detailed description
Specific Aims:
Hypothesis to be investigated: the integrated treatment effect of controlling inflammatory process through vedolizumab in active UC patients can be synergistically enhanced with a structured semi-vegetarian dietary intervention
Background and Significance:
Research of fecal microflora in UC has shown its influential role on the disease pathogenesis. In UC patients, the adaptive immune system is dysregulated and hyper-reactive to the commensal intestinal microflora in susceptible individuals and the diversity of intestinal flora decreases, called dysbiosis, by 30% to 50%. For the treatment of moderate to severe UC, tumor necrosis factor (TNF) antagonists, although efficacious but predispose patients to serious infection. Vedolizumab, a humanized monoclonal antibody that specifically recognizes the α4β7 heterodimer, selectively blocking the migration of leukocytes into inflamed intestinal tissue, has been shown to achieve clinical response and clinical remission in patients with moderate to severely active UC (clinical response 47% vs. 25% (placebo) at week 6 and clinical remission 42% vs. 16% (placebo) at week 52) in patients with moderate to severely active UC. In epidemiological study, western diet characterized with high in animal fat and low in fruits and vegetables has been found associated with an increased risk of IBD. In murine models, diets high saturated animal fats has been shown to be associated with dysbiosis, increased intestinal permeability, decreased mucus layer, and increased release of pro-inflammatory cytokines. Additive in processed food, such as emulsifiers, has been recently found with impact on the mouse gut microbiota promoting colitis and metabolic syndrome. Enteral nutritional therapy has been demonstrated effective in pediatric IBD patients; however, the application to adult IBD patients has not been widely accepted partly because of compliance and adherence to the diet. Recently, non-enteral dietary interventions, such as semi-vegetarian diet, specific carbohydrate diet, and IBD exclusion diet, have gained attention based on small non-randomized trials. In a small prospective clinical trial in CD patients, semi-vegetarian diet was well tolerated and 93% (16 out of 17) of patients remained in clinical remission, compared with 33% (2 out of 6 patients) in an omnivorous diet group, at 2 years. A well-designed randomized clinical trial using a structured dietary intervention, which integrates the merits of previously proposed diets, is warranted, especially in conjunction with the current standard of care (e.g. vedolizumab) and the novel normalization of dysbiosis through structured semi-vegetarian dietary intervention.
Research Design and Methods:
Study Design or Overview:
This study is a pilot study of evaluating the synergistic effect of vedolizumab in conjunction with structured semi-vegetarian dietary intervention on the treatment of active UC patients who will be under the treatment of Vedolizumab. Subjects will be screened at outpatient clinic visit appointments and interested, qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, baseline values will be established and subjects will begin treatment. A final visit for evaluation and collection of lab samples will be conducted at the end of the study at week 14.
Investigative Agent: vedolizumab in conjunction with semi-vegetarian dietary intervention:
Single interventional group: vedolizumab (300mg) IV infusions at week 0, 2, 6, 14 (as current standard of care) and concurrently on structured semi-vegetarian diet Duration of Therapy: 14 weeks; Duration of time on study: 14 weeks Structured semi-vegetarian dietary intervention (see supplementary material): Eligible study subjects will be counseled with a registered dietician and complete a Food Frequency Questionnaire to record and monitor the dietary pattern that the patient has at different time points, including prior to UC flare, current diet, diet during and after study.
The patient will be on a structured semi-vegetarian diet described below: (Specific recipes and food preparation will be provided during the counselling session with a dietician).
- Gradually increase calories, up to 25-30 kcals/kg/day
- Gradually add fiber (ex. white rice 2-5 days, then mixed rice 70% white to 30% brown rice) in an instructed regimen
- Daily vegetables, fruits, legumes, potatoes, probiotic food (miso, pickled vegetables), plain yogurt
- Encourage no smoking, regular physical exercise, moderate to no use of alcohol, regularity of meals, no snacking
- Foods to strictly limit/avoid: bread, cheese, margarine, fast foods, carbonated beverages, highly processed foods
- Diet excludes completely: Animal fat and Trans saturated fats, red meat and processed meat, sugar, emulsifiers (CMC, PS-80)
Sample Size:
Since this is a pilot study, no formal study power and sample size calculation is needed. The investigators plan to recruit 10 study subjects for the single interventional group.
Data Collection:
Clinical Assessments:
The primary outcome: Clinical response at week 6 (which is defined as ≥3 improvement in Mayo score (see page 4 for reference table), and a decrease of at least 30% from the baseline score).
The secondary outcome: Clinical response at week 14(which is defined as ≥3 improvement in Mayo score (see page 4 for reference table), and a decrease of at least 30% from the baseline score).
The investigators will also collect stool samples before (week -1) and after (week 14) the dietary interventions for microbiome study.
Data Analysis:
Univariate descriptive statistics and frequency distributions will be calculated, as appropriate for all variables including the primary and secondary outcomes. Baseline values for demographic, clinical, and outcome variables (primary and secondary) will be tabulated for the single interventional group. Primary outcome (clinical response rate at week 6) of this pilot study result will be non-analytically compared to the previously reported 47.1% from the previous clinical trial of vedolizumab alone in moderately to severe UC patients
Feasibility and Time Frame:
This is a pilot study and 10 study subjects will be enrolled by the end of 2017. Based on the current volume of eligible patients at the institution, it will be expected to complete the recruitment in 3 to 4 months. The completion of this study is estimated to be within 4 months.
- Conditions
- Ulcerative Colitis, Dietary Modification
- Being tested
- semi-vegetarian diet, Vedolizumab Injection
- Keywords
- semi-vegetarian diet, vedolizumab, ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-vegetarian dietDietary supplement
semi-vegetarian dietary intervention: Duration of Therapy: 14 weeks;
Vedolizumab InjectionDrug
Also called vedolizumab
vedolizumab (300mg) IV infusions at week 0, 2, 6, 14; Duration of Therapy: 14 weeks
| Study group | Role | What they receive |
|---|---|---|
| Combined diet and vedolizumab | Experimental | Intervention: vedolizumab injection (300mg, IV infusions at week 0, 2, 6, 14) and concurrently on structured semi-vegetarian diet; Duration of Therapy: 14 weeks Receives: Dietary Supplement: semi-vegetarian diet; Drug: Vedolizumab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response at week 6
Clinical response at week 6 (which is defined as ≥3 improvement in Mayo score, and a decrease of at least 30% from the baseline score).
Measured: 6 weeks
Secondary outcomes (1)
Clinical response at week 14
Clinical response at week 14(which is defined as ≥3 improvement in Mayo score, and a decrease of at least 30% from the baseline score).
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start25 Dec 2017
- Primary completion31 Aug 2018
- Study completion31 Dec 2018 (estimated)
Why it stopped: Not enough patients to enroll.
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.
- More trials run by Mayo ClinicThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-Hsi Wang, Mayo Clinic
- Investigators
- Ming-Hsi Wang, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309865
- Sponsor's protocol ID
- IRB 17-005613
- Status last verified
- Sep 2018
- First submitted
- 7 Oct 2017
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Synergistic Effect of Vedolizumab in Conjunction With Structured Semi-Vegetarian Diet on the Treatment of Ulcerative Colitis.
- ClinicalTrials.gov ID
- NCT03309865
- Acronym / sponsor ID
- IRB 17-005613
- Conditions
- Ulcerative Colitis, Dietary Modification
- Keywords
- semi-vegetarian diet, vedolizumab, ulcerative colitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough patients to enroll.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Dec 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 16 Oct 2017 (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.
Research of fecal microflora and dysbiosis status in ulcerative colitis (UC) has shown its influential role on the disease pathogenesis. Vedolizumab, a humanized monoclonal antibody blocking the migration of leukocytes into inflamed intestinal tissue, has been shown to achieve remission in about half of active UC patients. Dietary intervention in UC patients has not been adequately studied. There is a significant clinical gap to achieve a higher efficacy and better clinical outcomes on the treatment of active UC patients. This study proposes to assess the integrated effect of normalization of intestinal dysbiosis through a structured semi-vegetarian dietary intervention in active UC patients who will also be under the standard of care medical therapy (vedolizumab).
Significance of investigation for innovation: The pathogenesis of UC has been found to be multi-factorial, including host genetics and dysregulated inflammatory response, and recent research has shown the influential role of gut environmental factors - dysbiosis which has been found the key feature of UC. Vedolizumab has been shown effective (e.g. 47% clinical response rate vs. 25% in placebo group) and is part of the current standard of care treatment in UC. With the observation of drastic increase of IBD patients in Asia, in which has historically low incidence of IBD, it is generally accepted that the westernized diet and urbanization of life style play an important role in IBD pathogenesis. Enteral nutritional therapy has been demonstrated effective in pediatric Crohn's disease (CD) patients; however, the application to adult IBD patients has not been widely accepted partly because of the compliance issue. In addition, unlike CD, neither enteral nutrition nor non-enteral nutrition in patients with active UC has been adequately studied. Therefore, this study proposes a novel approach to assess the integrated effect of a structured dietary intervention in active UC patients who will also be under the current standard of care medical therapy (vedolizumab). After this study achieves the proposed primary or secondary outcome, it will further support the hypothesized synergistic interactive therapeutic effect between the normalization of dysbiosis in the intestine (through dietary intervention) and anti-inflammatory biologics (vedolizumab).
Detailed description
Specific Aims:
Hypothesis to be investigated: the integrated treatment effect of controlling inflammatory process through vedolizumab in active UC patients can be synergistically enhanced with a structured semi-vegetarian dietary intervention
Background and Significance:
Research of fecal microflora in UC has shown its influential role on the disease pathogenesis. In UC patients, the adaptive immune system is dysregulated and hyper-reactive to the commensal intestinal microflora in susceptible individuals and the diversity of intestinal flora decreases, called dysbiosis, by 30% to 50%. For the treatment of moderate to severe UC, tumor necrosis factor (TNF) antagonists, although efficacious but predispose patients to serious infection. Vedolizumab, a humanized monoclonal antibody that specifically recognizes the α4β7 heterodimer, selectively blocking the migration of leukocytes into inflamed intestinal tissue, has been shown to achieve clinical response and clinical remission in patients with moderate to severely active UC (clinical response 47% vs. 25% (placebo) at week 6 and clinical remission 42% vs. 16% (placebo) at week 52) in patients with moderate to severely active UC. In epidemiological study, western diet characterized with high in animal fat and low in fruits and vegetables has been found associated with an increased risk of IBD. In murine models, diets high saturated animal fats has been shown to be associated with dysbiosis, increased intestinal permeability, decreased mucus layer, and increased release of pro-inflammatory cytokines. Additive in processed food, such as emulsifiers, has been recently found with impact on the mouse gut microbiota promoting colitis and metabolic syndrome. Enteral nutritional therapy has been demonstrated effective in pediatric IBD patients; however, the application to adult IBD patients has not been widely accepted partly because of compliance and adherence to the diet. Recently, non-enteral dietary interventions, such as semi-vegetarian diet, specific carbohydrate diet, and IBD exclusion diet, have gained attention based on small non-randomized trials. In a small prospective clinical trial in CD patients, semi-vegetarian diet was well tolerated and 93% (16 out of 17) of patients remained in clinical remission, compared with 33% (2 out of 6 patients) in an omnivorous diet group, at 2 years. A well-designed randomized clinical trial using a structured dietary intervention, which integrates the merits of previously proposed diets, is warranted, especially in conjunction with the current standard of care (e.g. vedolizumab) and the novel normalization of dysbiosis through structured semi-vegetarian dietary intervention.
Research Design and Methods:
Study Design or Overview:
This study is a pilot study of evaluating the synergistic effect of vedolizumab in conjunction with structured semi-vegetarian dietary intervention on the treatment of active UC patients who will be under the treatment of Vedolizumab. Subjects will be screened at outpatient clinic visit appointments and interested, qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, baseline values will be established and subjects will begin treatment. A final visit for evaluation and collection of lab samples will be conducted at the end of the study at week 14.
Investigative Agent: vedolizumab in conjunction with semi-vegetarian dietary intervention:
Single interventional group: vedolizumab (300mg) IV infusions at week 0, 2, 6, 14 (as current standard of care) and concurrently on structured semi-vegetarian diet Duration of Therapy: 14 weeks; Duration of time on study: 14 weeks Structured semi-vegetarian dietary intervention (see supplementary material): Eligible study subjects will be counseled with a registered dietician and complete a Food Frequency Questionnaire to record and monitor the dietary pattern that the patient has at different time points, including prior to UC flare, current diet, diet during and after study.
The patient will be on a structured semi-vegetarian diet described below: (Specific recipes and food preparation will be provided during the counselling session with a dietician).
- Gradually increase calories, up to 25-30 kcals/kg/day
- Gradually add fiber (ex. white rice 2-5 days, then mixed rice 70% white to 30% brown rice) in an instructed regimen
- Daily vegetables, fruits, legumes, potatoes, probiotic food (miso, pickled vegetables), plain yogurt
- Encourage no smoking, regular physical exercise, moderate to no use of alcohol, regularity of meals, no snacking
- Foods to strictly limit/avoid: bread, cheese, margarine, fast foods, carbonated beverages, highly processed foods
- Diet excludes completely: Animal fat and Trans saturated fats, red meat and processed meat, sugar, emulsifiers (CMC, PS-80)
Sample Size:
Since this is a pilot study, no formal study power and sample size calculation is needed. The investigators plan to recruit 10 study subjects for the single interventional group.
Data Collection:
Clinical Assessments:
The primary outcome: Clinical response at week 6 (which is defined as ≥3 improvement in Mayo score (see page 4 for reference table), and a decrease of at least 30% from the baseline score).
The secondary outcome: Clinical response at week 14(which is defined as ≥3 improvement in Mayo score (see page 4 for reference table), and a decrease of at least 30% from the baseline score).
The investigators will also collect stool samples before (week -1) and after (week 14) the dietary interventions for microbiome study.
Data Analysis:
Univariate descriptive statistics and frequency distributions will be calculated, as appropriate for all variables including the primary and secondary outcomes. Baseline values for demographic, clinical, and outcome variables (primary and secondary) will be tabulated for the single interventional group. Primary outcome (clinical response rate at week 6) of this pilot study result will be non-analytically compared to the previously reported 47.1% from the previous clinical trial of vedolizumab alone in moderately to severe UC patients
Feasibility and Time Frame:
This is a pilot study and 10 study subjects will be enrolled by the end of 2017. Based on the current volume of eligible patients at the institution, it will be expected to complete the recruitment in 3 to 4 months. The completion of this study is estimated to be within 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined diet and vedolizumab | Experimental | Dietary Supplement: semi-vegetarian diet, Drug: Vedolizumab InjectionIntervention: vedolizumab injection (300mg, IV infusions at week 0, 2, 6, 14) and concurrently on structured semi-vegetarian diet; Duration of Therapy: 14 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- diagnosed with active UC (with a Mayo score ≥4, with an endoscopic Mayo Clinic score ≥1, and disease that extended 15 cm or more from the anal verge)
- failed with prior mesalamine therapy
- Patients who were previously exposed to mesalamine or steroids will have a 30-day washout period before being enrolled
- Patients who were previously exposed to tumor necrosis factor (TNF) antagonists will have a 60-day washout period before being enrolled
Key exclusion criteria (22 listed)
- Patients who have been on semi-vegetarian diet before the trial will be excluded
- pregnancy or lactation
- an unstable or uncontrolled medical disorder
- an anticipated requirement for major surgery
- history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC, or planned bowel surgery
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 |
|---|---|---|
| semi-vegetarian dietsemi-vegetarian dietary intervention: Duration of Therapy: 14 weeks; | Dietary supplement | Combined diet and vedolizumab |
| Vedolizumab InjectionAlso: vedolizumabvedolizumab (300mg) IV infusions at week 0, 2, 6, 14; Duration of Therapy: 14 weeks | Drug | Combined diet and vedolizumab |
Primary outcome
Clinical response at week 6
Time frame: 6 weeks
Clinical response at week 6 (which is defined as ≥3 improvement in Mayo score, and a decrease of at least 30% from the baseline score).
1 secondary outcome
Clinical response at week 14
Time frame: 14 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 26 Sep 2018.
- Individual participant dataSharing planned: No
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
Ming-Hsi Wang, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing semi-vegetarian diet and Vedolizumab Injection in people with Ulcerative Colitis and Dietary Modification, run by Mayo Clinic 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 7 inclusion and 22 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 26 Sep 2018. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 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?
Clinical response at week 6 (time frame: 6 weeks). 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 26 Sep 2018.