Decentralized Dietary UC Pilot Trial
5. november 2015 oppdatert av: Transparency Life Sciences
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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
51
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Massachusetts
-
Brookline, Massachusetts, Forente stater, 02467
- Rekruttering
- Crohn's and Colitis Center at Brigham and Women's Hospital
-
Hovedetterforsker:
- Joshua Korzenik, MD
-
Ta kontakt med:
- Justine States
- Telefonnummer: 617-732-9110
- E-post: dietaryUCTrial@partners.org
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Traditional
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). |
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.
|
|
Aktiv komparator: Remote
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). |
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score)
Tidsramme: 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.
|
Week 1
|
|
Compliance (proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study)
Tidsramme: 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.
|
Week 7
|
|
Combined Anti-inflammatory Diet (Change from baseline in fecal calprotectin/microbiome levels)
Tidsramme: Weeks 0, 5 and 7
|
Change from baseline in fecal calprotectin/microbiome levels between Control (standard nutritional advice) and CAID (dietary intervention) arms.
|
Weeks 0, 5 and 7
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mayo Score and Patient Simple Clinical Colitis Activity Index Difference (Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index)
Tidsramme: Weeks 1 and 7
|
Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index between Control and CAID (dietary intervention).
|
Weeks 1 and 7
|
|
Adverse Events
Tidsramme: Weekly through week 11
|
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.
|
Weekly through week 11
|
|
Dietary Compliance Comparison
Tidsramme: Week 7
|
Comparison of patient non-compliance events with dietary regimen between arms 1 and 2.
|
Week 7
|
|
Participant Satisfaction Survey
Tidsramme: Week 7
|
Difference in reported patient satisfaction with trial participation between arms 1 and 2.
|
Week 7
|
|
Mayo Score Discrepancy Frequency
Tidsramme: Week 7
|
Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Endoscopy Sub-Scores for Arm 2 patients at baseline.
|
Week 7
|
|
Physician's Global Assessment Discrepancy Frequency
Tidsramme: Week 7
|
Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Physician's Global Assessment Sub-Score for Arm 2 patients at baseline.
|
Week 7
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Tomasz Sablinski, MD, PhD, Transparency Life Sciences
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2015
Primær fullføring (Forventet)
1. desember 2016
Datoer for studieregistrering
Først innsendt
23. januar 2015
Først innsendt som oppfylte QC-kriteriene
2. februar 2015
Først lagt ut (Anslag)
6. februar 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. november 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. november 2015
Sist bekreftet
1. november 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- TLS-UC-003
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .