Colitis, UlcerativeNCT02357537
Decentralized Dietary UC Pilot Trial
A study testing Combined Anti-inflammatory Diet (CAID) in people with Colitis, Ulcerative, run by Transparency Life Sciences at 1 site in United States.
Trial summary
This study is designed to assess differences in remote and on-site patient study participation in the State of Massachusetts, as well as the significance of dietary interventions and their impact on UC. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Combined Anti-inflammatory Diet (CAID)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females between the ages of 18 and 80, inclusive, who reside in the state of Massachusetts.
- Ability and willingness to provide documented informed consent and to comply with the study procedures, including in-person visits for Arm 1 and video visits for Arm 2.
- Documented history of moderate to severe active UC
- Disease duration of ≥12 weeks at the time of screening (diagnosed according to American College of Gastroenterology practice guidelines)
- Screening fecal calprotectin>350 mg/g
- Diagnosis of moderately to severely active UC, including historical endoscopy sub score ≥2; a rectal bleeding sub score ≥1 and disease activity a minimum of 25 cm from the anal verge.
- Documented (via video or report) endoscopy performed within 2 years prior to randomization.
- Access to a computer or mobile device with internet connection and an active email address.
Who cannot join
- Prior extensive colonic resection, subtotal or total colectomy or planned surgery for UC
- Past or present ileostomy or colostomy
- Short bowel syndrome
- Diagnosis of indeterminate colitis, fulminant colitis, toxic megacolon
- Past or present fistula or abdominal abscess
- History or current evidence of colonic mucosal dysplasia
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- Use of tube feeding, defined formula diets or parenteral alimentation/nutrition which has not been discontinued ≥3 weeks prior to study enrollment
- Use of anticoagulants, herbal supplements and omega-3/fish oil supplements during the study
- Crohn's Disease
- Significant uncontrolled co-morbidity, such as neurological, cardiac (e.g., moderate to severe heart failure NYHA class III/IV), pulmonary, renal, hepatic, endocrine or gastrointestinal disorders
- History of alcohol, drug or chemical abuse within 6 months prior to screening
- Pregnant females, those intending to become pregnant, and those who are lactating
- Current participation in any other clinical trial
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Crohn's and Colitis Center at Brigham and Women's Hospital
Brookline, Massachusetts, 02467
Justine States, 617-732-9110, dietaryUCTrial@partners.org
Joshua Korzenik, MD
About this study
Official title: A Pilot Study Investigating a Decentralized Approach to Studying Dietary Intervention in Patients With Ulcerative Colitis
This study is designed to assess differences in remote and on-site patient study participation in the State of Massachusetts, as well as the significance of dietary interventions and their impact on UC. The study will activate one site with a Principal Investigator who will utilize each subject's local care system (local Gastroenterologist) to collect study data, along with telemonitoring and video visits, to make key study assessments and decisions regarding subjects' progression in the study.
- Conditions
- Colitis, Ulcerative
- Being tested
- Combined Anti-inflammatory Diet (CAID)
- Keywords
- Telemedicine
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Anti-inflammatory Diet (CAID)Behavioural
The CAID requires participants to modify their diet to include certain types of foods that may have anti-inflammatory properties. Participants on the CAID will be required to abstain from red meat and alcoholic beverages.
| Study group | Role | What they receive |
|---|---|---|
| Traditional | Active comparator | Subjects in Study Arm 1 will undergo a screening process, and if randomized, will follow a traditional, site-based clinical trial model and undergo a baseline visit and 3 more in-person visits with the Principal Investigator (total of 4 visits).
Subjects in each Study Arm will be randomized (2:1) to follow one of two dietary regimens during the study: the Combined Anti-Inflammatory Diet (CAID) or Control (standard nutritional advice). Receives: Behavioral: Combined Anti-inflammatory Diet (CAID) |
| Remote | Active comparator | Subjects in Study Arm 2 will undergo a screening process, and if randomized, will undergo one Baseline visit at the local Gastroenterologist's office and 4 video visits with the Principal Investigator. A mobile nurse will visit subjects at a distant location (such as their home) to obtain blood samples at visits 1 and 4.
Subjects in each Study Arm will be randomized (2:1) to follow one of two dietary regimens during the study: the Combined Anti-Inflammatory Diet (CAID) or Control (standard nutritional advice). Receives: Behavioral: Combined Anti-inflammatory Diet (CAID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score)
Comparison of the proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score between Study Arms 1 and 2.
Measured: Week 1
Compliance (proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study)
Comparison of the proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study between Study Arms 1 and 2.
Measured: Week 7
Combined Anti-inflammatory Diet (Change from baseline in fecal calprotectin/microbiome levels)
Change from baseline in fecal calprotectin/microbiome levels between Control (standard nutritional advice) and CAID (dietary intervention) arms.
Measured: Weeks 0, 5 and 7
Secondary outcomes (6)
Mayo Score and Patient Simple Clinical Colitis Activity Index Difference (Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index)
Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index between Control and CAID (dietary intervention).
Measured: Weeks 1 and 7
Adverse Events
Difference in incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) between Study Arms 1 and 2 and between Control and CAID (dietary intervention) arms.
Measured: Weekly through week 11
Dietary Compliance Comparison
Comparison of patient non-compliance events with dietary regimen between arms 1 and 2.
Measured: Week 7
Participant Satisfaction Survey
Difference in reported patient satisfaction with trial participation between arms 1 and 2.
Measured: Week 7
Mayo Score Discrepancy Frequency
Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Endoscopy Sub-Scores for Arm 2 patients at baseline.
Measured: Week 7
Physician's Global Assessment Discrepancy Frequency
Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Physician's Global Assessment Sub-Score for Arm 2 patients at baseline.
Measured: Week 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transparency Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomasz Sablinski, MD, PhD, Study director, Transparency Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357537
- Sponsor's protocol ID
- TLS-UC-003
- Status last verified
- Nov 2015
- First submitted
- 23 Jan 2015
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating a Decentralized Approach to Studying Dietary Intervention in Patients With Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02357537
- Acronym / sponsor ID
- TLS-UC-003
- Conditions
- Colitis, Ulcerative
- Keywords
- Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Transparency Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Dec 2016 (estimated)
- First posted
- 6 Feb 2015 (estimated)
- 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.
This study is designed to assess differences in remote and on-site patient study participation in the State of Massachusetts, as well as the significance of dietary interventions and their impact on UC. The study will activate one site with a Principal Investigator who will utilize each subject's local care system (local Gastroenterologist) to collect study data, along with telemonitoring and video visits, to make key study assessments and decisions regarding subjects' progression in the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional | Active comparator | Behavioral: Combined Anti-inflammatory Diet (CAID)Subjects in Study Arm 1 will undergo a screening process, and if randomized, will follow a traditional, site-based clinical trial model and undergo a baseline visit and 3 more in-person visits with the Principal Investigator (total of 4 visits). Subjects in each Study Arm will be randomized (2:1) to follow one of two dietary regimens during the study: the Combined Anti-Inflammatory Diet (CAID) or Control (standard nutritional advice). |
| Remote | Active comparator | Behavioral: Combined Anti-inflammatory Diet (CAID)Subjects in Study Arm 2 will undergo a screening process, and if randomized, will undergo one Baseline visit at the local Gastroenterologist's office and 4 video visits with the Principal Investigator. A mobile nurse will visit subjects at a distant location (such as their home) to obtain blood samples at visits 1 and 4. Subjects in each Study Arm will be randomized (2:1) to follow one of two dietary regimens during the study: the Combined Anti-Inflammatory Diet (CAID) or Control (standard nutritional advice). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females between the ages of 18 and 80, inclusive, who reside in the state of Massachusetts.
- Ability and willingness to provide documented informed consent and to comply with the study procedures, including in-person visits for Arm 1 and video visits for Arm 2.
- Documented history of moderate to severe active UC
- Disease duration of ≥12 weeks at the time of screening (diagnosed according to American College of Gastroenterology practice guidelines)
- Screening fecal calprotectin>350 mg/g
Key exclusion criteria (13 listed)
- Prior extensive colonic resection, subtotal or total colectomy or planned surgery for UC
- Past or present ileostomy or colostomy
- Short bowel syndrome
- Diagnosis of indeterminate colitis, fulminant colitis, toxic megacolon
- Past or present fistula or abdominal abscess
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 |
|---|---|---|
| Combined Anti-inflammatory Diet (CAID)The CAID requires participants to modify their diet to include certain types of foods that may have anti-inflammatory properties. Participants on the CAID will be required to abstain from red meat and alcoholic beverages. | Behavioural | Remote, Traditional |
Primary outcome
Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score)
Time frame: Week 1
Comparison of the proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score between Study Arms 1 and 2.
Compliance (proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study)
Time frame: Week 7
Comparison of the proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study between Study Arms 1 and 2.
Combined Anti-inflammatory Diet (Change from baseline in fecal calprotectin/microbiome levels)
Time frame: Weeks 0, 5 and 7
Change from baseline in fecal calprotectin/microbiome levels between Control (standard nutritional advice) and CAID (dietary intervention) arms.
6 secondary outcomes
Mayo Score and Patient Simple Clinical Colitis Activity Index Difference (Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index)
Time frame: Weeks 1 and 7
Adverse Events
Time frame: Weekly through week 11
Dietary Compliance Comparison
Time frame: Week 7
Participant Satisfaction Survey
Time frame: Week 7
Mayo Score Discrepancy Frequency
Time frame: Week 7
Physician's Global Assessment Discrepancy Frequency
Time frame: Week 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
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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.
Tomasz Sablinski, MD, PhD study director
Transparency Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Anti-inflammatory Diet (CAID) in people with Colitis, Ulcerative, run by Transparency Life Sciences 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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 6 Nov 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Justine States ((617) 732-9110, dietaryUCTrial@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score) (time frame: Week 1). 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 6 Nov 2015; AzTrials last refreshed its copy on 29 Oct 2026.