Ulcerative ColitisNCT04933162
UC Cohort - The Influence of Diet on Gut Microbiotas
A study testing High Protein and Low Fiber Diet and Low Protein and High Fiber Diet in people with Ulcerative Colitis, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this research is to determine if different diets have different effects on the inflammation in the colon. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- High Protein and Low Fiber Diet and Low Protein and High Fiber Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2021to 17 Feb 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years old
- Ability to give informed consent
- Diagnosis of ulcerative colitis
- Moderate UC disease activity defined by a Mayo Score of >6 with endoscopic score of 2
- On a baseline diet characterized by:
- Fiber intake of < 15g/day
- > 18% of daily calories from protein
Who cannot join
- Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
- Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
- Use of NSAIDs or aspirin and unable or unwilling to stop taking two weeks prior to permeability test and for the duration of the study
- Use of osmotic laxatives and unable or unwilling to stop taking one week prior to permeability test and for the duration of the study
- Use of oral corticosteroids and unable or unwilling to stop use of oral corticosteroids within the previous 2 weeks and for the duration of the study
- Multiple dietary restrictions or unable/unwilling to alter dietary protein or dietary fiber.
Show all 16Show fewer
- Unwilling to stop ingestion of alcohol and artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages
- Unwilling to stop stenuous exercise (running >5 miles or equivalent) one week prior to the permeability tests
- Bowel preparation for colonoscopy less than one week prior to completion of the first stool kit and permeability test and flexible sigmoidoscopy and upper endoscopy
- Pregnancy or plan to become pregnant during the study time frame
- Vulnerable adult
- Known bleeding disorders or takes medications that increase risk of bleeding from mucosal biopsies
- Use of oral antibiotic(s) within the past 4 weeks (can be enrolled after 4-week washout period)
- Use of commercial probiotic formulations and unwilling to stop for the duration of the study
- Diagnosis of diabetes
- Any other disease(s), condition(s) or habits(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: UC Cohort - The Influence of Diet on Host Physiology and Disease Across Diverse Human Gut Microbiotas
The purpose of this research is to determine if different diets have different effects on the inflammation in the colon.
- Conditions
- Ulcerative Colitis
- Being tested
- High Protein and Low Fiber Diet, Low Protein and High Fiber Diet
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein and Low Fiber DietDietary supplement
Protein intake will be increased to be >40% calories from protein, and the fiber intake will remain <15gm/day.
Low Protein and High Fiber DietDietary supplement
Increase fiber intake up to 40gms of fiber with a requirement to increase at least 15gms above baseline fiber, with 50-75% of total fiber intake from psyllium husk. Subjects will be allowed to slowly increase fiber every two days to reach goal by end of week 1. The total protein will be reduced to <10% total calories from protein.
| Study group | Role | What they receive |
|---|---|---|
| High Protein and Low Fiber Group | Experimental | Subjects will consume a high protein and low fiber diet for 8 weeks Receives: Dietary Supplement: High Protein and Low Fiber Diet |
| Low Protein and High Fiber Group | Experimental | Subjects will consume a low protein and high fiber diet for 8 weeks Receives: Dietary Supplement: Low Protein and High Fiber Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in endoscopic Mayo score for ulcerative colitis inflammation
Measured from unprepped, non-sedated flexible sigmoidoscopy by decrease in Mayo score with a decrease of at least 1 point on the endoscopic subscore or absolute endoscopic subscore of 0-1).
Measured: 8 weeks
Clinical remission derived from patient reported outcomes
Defined as a Mayo score ≤2 and no sub-scores with a value greater than 1 is a secondary endpoint. This what the patient reports for stool frequency and reporting of any blood in the stool
Measured: 8 weeks
Secondary outcomes (2)
Intestinal inflammation determined from blood and stool samples
Measures C-reactive protein from blood samples and fecal calprotectin from stool samples
Measured: 8 weeks
Urinary excretion of lactulose and 13C-Mannitol
Small Bowel and Colonic Permeability by Urinary Excretion of Lactulose and 13C-Mannitol after Oral Ingestion of lactulose and 13C mannitol (5:1 ratio by mass). The 0-2h urine most closely reflects small intestinal permeability and 8-24h urine reflects colonic permeability. HPLC-tandem mass spectrometry will be used for detection of the sugars. The results will be expressed as the ratio of percentage excretion of the ingested dose of lactulose and mannitol in urine.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start3 Aug 2021
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura E. Raffals, M.D, Mayo Clinic
- Investigators
- Laura Raffals, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933162
- Sponsor's protocol ID
- 20-012389
- Status last verified
- Jul 2023
- First submitted
- 15 Jun 2021
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UC Cohort - The Influence of Diet on Host Physiology and Disease Across Diverse Human Gut Microbiotas
- ClinicalTrials.gov ID
- NCT04933162
- Acronym / sponsor ID
- 20-012389
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Aug 2021 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 21 Jun 2021 (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 purpose of this research is to determine if different diets have different effects on the inflammation in the colon.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Protein and Low Fiber Group | Experimental | Dietary Supplement: High Protein and Low Fiber DietSubjects will consume a high protein and low fiber diet for 8 weeks |
| Low Protein and High Fiber Group | Experimental | Dietary Supplement: Low Protein and High Fiber DietSubjects will consume a low protein and high fiber diet for 8 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)
- Adults ≥ 18 years old
- Ability to give informed consent
- Diagnosis of ulcerative colitis
- Moderate UC disease activity defined by a Mayo Score of >6 with endoscopic score of 2
- On a baseline diet characterized by:
Key exclusion criteria (16 listed)
- Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
- Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
- Use of NSAIDs or aspirin and unable or unwilling to stop taking two weeks prior to permeability test and for the duration of the study
- Use of osmotic laxatives and unable or unwilling to stop taking one week prior to permeability test and for the duration of the study
- Use of oral corticosteroids and unable or unwilling to stop use of oral corticosteroids within the previous 2 weeks and for the duration of the study
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 |
|---|---|---|
| High Protein and Low Fiber DietProtein intake will be increased to be >40% calories from protein, and the fiber intake will remain <15gm/day. | Dietary supplement | High Protein and Low Fiber Group |
| Low Protein and High Fiber DietIncrease fiber intake up to 40gms of fiber with a requirement to increase at least 15gms above baseline fiber, with 50-75% of total fiber intake from psyllium husk. Subjects will be allowed to slowly increase fiber every two days to reach goal by end of week 1. The total protein will be reduced to <10% total calories from protein. | Dietary supplement | Low Protein and High Fiber Group |
Primary outcome
Decrease in endoscopic Mayo score for ulcerative colitis inflammation
Time frame: 8 weeks
Measured from unprepped, non-sedated flexible sigmoidoscopy by decrease in Mayo score with a decrease of at least 1 point on the endoscopic subscore or absolute endoscopic subscore of 0-1).
Clinical remission derived from patient reported outcomes
Time frame: 8 weeks
Defined as a Mayo score ≤2 and no sub-scores with a value greater than 1 is a secondary endpoint. This what the patient reports for stool frequency and reporting of any blood in the stool
2 secondary outcomes
Intestinal inflammation determined from blood and stool samples
Time frame: 8 weeks
Urinary excretion of lactulose and 13C-Mannitol
Time frame: 8 weeks
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 25 Jul 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Laura Raffals, MD 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 study testing High Protein and Low Fiber Diet and Low Protein and High Fiber Diet in people with Ulcerative Colitis, 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 16 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 25 Jul 2023. 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?
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?
Decrease in endoscopic Mayo score for ulcerative colitis inflammation (time frame: 8 weeks). The study lists 2 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 25 Jul 2023.