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Decentralized Dietary UC Pilot Trial

5 novembre 2015 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

51

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Massachusetts
      • Brookline, Massachusetts, États-Unis, 02467
        • Recrutement
        • Crohn's and Colitis Center at Brigham and Women's Hospital
        • Chercheur principal:
          • Joshua Korzenik, MD
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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).
Comportemental: 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.
Comparateur actif: 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).
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score)
Délai: 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)
Délai: 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)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Mayo Score and Patient Simple Clinical Colitis Activity Index Difference (Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index)
Délai: 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
Délai: 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
Délai: Week 7
Comparison of patient non-compliance events with dietary regimen between arms 1 and 2.
Week 7
Participant Satisfaction Survey
Délai: Week 7
Difference in reported patient satisfaction with trial participation between arms 1 and 2.
Week 7
Mayo Score Discrepancy Frequency
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Transparency Life Sciences

Les enquêteurs

  • Directeur d'études: Tomasz Sablinski, MD, PhD, Transparency Life Sciences

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2015

Achèvement primaire (Anticipé)

1 décembre 2016

Dates d'inscription aux études

Première soumission

23 janvier 2015

Première soumission répondant aux critères de contrôle qualité

2 février 2015

Première publication (Estimation)

6 février 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

6 novembre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 novembre 2015

Dernière vérification

1 novembre 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • TLS-UC-003

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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