- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02357537
Decentralized Dietary UC Pilot Trial
A Pilot Study Investigating a Decentralized Approach to Studying Dietary Intervention in Patients With Ulcerative Colitis
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Brookline, Massachusetts, Stati Uniti, 02467
- Reclutamento
- Crohn's and Colitis Center at Brigham and Women's Hospital
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Investigatore principale:
- Joshua Korzenik, MD
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Contatto:
- Justine States
- Numero di telefono: 617-732-9110
- Email: dietaryUCTrial@partners.org
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore attivo: 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.
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Comparatore attivo: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score)
Lasso di tempo: Week 1
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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.
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Week 1
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Compliance (proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study)
Lasso di tempo: Week 7
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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.
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Week 7
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Combined Anti-inflammatory Diet (Change from baseline in fecal calprotectin/microbiome levels)
Lasso di tempo: Weeks 0, 5 and 7
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Change from baseline in fecal calprotectin/microbiome levels between Control (standard nutritional advice) and CAID (dietary intervention) arms.
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Weeks 0, 5 and 7
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Mayo Score and Patient Simple Clinical Colitis Activity Index Difference (Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index)
Lasso di tempo: Weeks 1 and 7
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Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index between Control and CAID (dietary intervention).
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Weeks 1 and 7
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Adverse Events
Lasso di tempo: Weekly through week 11
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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.
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Weekly through week 11
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Dietary Compliance Comparison
Lasso di tempo: Week 7
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Comparison of patient non-compliance events with dietary regimen between arms 1 and 2.
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Week 7
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Participant Satisfaction Survey
Lasso di tempo: Week 7
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Difference in reported patient satisfaction with trial participation between arms 1 and 2.
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Week 7
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Mayo Score Discrepancy Frequency
Lasso di tempo: Week 7
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Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Endoscopy Sub-Scores for Arm 2 patients at baseline.
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Week 7
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Physician's Global Assessment Discrepancy Frequency
Lasso di tempo: Week 7
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Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Physician's Global Assessment Sub-Score for Arm 2 patients at baseline.
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Week 7
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Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Tomasz Sablinski, MD, PhD, Transparency Life Sciences
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- TLS-UC-003
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Combined Anti-inflammatory Diet (CAID)
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Vegenat, S.A.SconosciutoMorbo di Parkinson | Il morbo di Alzheimer | Demenza senileSpagna