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Decentralized Dietary UC Pilot Trial

5. november 2015 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

51

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Brookline, Massachusetts, Forenede Stater, 02467
        • Rekruttering
        • Crohn's and Colitis Center at Brigham and Women's Hospital
        • Ledende efterforsker:
          • Joshua Korzenik, MD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Males and females between the ages of 18 and 80, inclusive, who reside in the state of Massachusetts.
  2. 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.
  3. Documented history of moderate to severe active UC
  4. Disease duration of ≥12 weeks at the time of screening (diagnosed according to American College of Gastroenterology practice guidelines)
  5. Screening fecal calprotectin>350 mg/g
  6. 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.
  7. Documented (via video or report) endoscopy performed within 2 years prior to randomization.
  8. Access to a computer or mobile device with internet connection and an active email address.

Exclusion Criteria:

  1. Prior extensive colonic resection, subtotal or total colectomy or planned surgery for UC
  2. Past or present ileostomy or colostomy
  3. Short bowel syndrome
  4. Diagnosis of indeterminate colitis, fulminant colitis, toxic megacolon
  5. Past or present fistula or abdominal abscess
  6. History or current evidence of colonic mucosal dysplasia
  7. Use of tube feeding, defined formula diets or parenteral alimentation/nutrition which has not been discontinued ≥3 weeks prior to study enrollment
  8. Use of anticoagulants, herbal supplements and omega-3/fish oil supplements during the study
  9. Crohn's Disease
  10. 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
  11. History of alcohol, drug or chemical abuse within 6 months prior to screening
  12. Pregnant females, those intending to become pregnant, and those who are lactating
  13. Current participation in any other clinical trial

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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).
Adfærdsmæssigt: 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.
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).
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Transparency Life Sciences

Efterforskere

  • Studieleder: Tomasz Sablinski, MD, PhD, Transparency Life Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2015

Primær færdiggørelse (Forventet)

1. december 2016

Datoer for studieregistrering

Først indsendt

23. januar 2015

Først indsendt, der opfyldte QC-kriterier

2. februar 2015

Først opslået (Skøn)

6. februar 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2015

Sidst verificeret

1. november 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TLS-UC-003

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Colitis, Ulcerativ

Kliniske forsøg med Combined Anti-inflammatory Diet (CAID)

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Armenia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner