Tailored Anti-Inflammatory American Diet for Patients With Crohn's Disease
22. Juni 2026 aktualisiert von: Oriana Mazorra Damas, University of Miami
Targeting Gut Inflammation Through Diet: a Tailored American Diet for Patients With Crohn's Disease
The purpose of this study is to test the effect of an anti-inflammatory diet tailored for patients living in the United States with Crohn's Disease (CD) on clinical symptoms and disease inflammation and to identify biomarkers of response to dietary therapy.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
122
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Eytan I Stern, MS, RD, LD/N, CNSC
- Telefonnummer: 305-243-6405
- E-Mail: eis43@miami.edu
Studienorte
-
-
Florida
-
Miami, Florida, Vereinigte Staaten, 33136
- University of Miami
-
Kontakt:
- Eytan I Stern, MS, RD, LD/N, CNSC
- Telefonnummer: 305-243-6405
- E-Mail: eis43@miami.edu
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Inclusion Criteria:
- Documented diagnosis with Crohn's Disease from medical records.
- Ages 16-75
- Mild to moderately active CD disease, defined by one of the following criteria:
Crohn's disease activity index (CDAI) 150-250 (mild-to-moderate only active disease) AND presence of active inflammation either by: fecal calprotectin >150mg/dl. or radiologic findings of active ileal and/or colonic disease, or endoscopic findings showing active ileal and/or colonic disease within 4 weeks of baseline
-On stable medications for their disease as or 3 months if medication is not listed
Exclusion Criteria:
- Diagnosis of Ulcerative Colitis (UC).
- Prior J pouch or diversion
- Recent inflammatory bowel disease (IBD) related hospitalizations in the last 4 weeks
- Clostridium difficile or enteric infections in the last 4 weeks
- Use of probiotics in the last 4 weeks
- Patients following the specific carbohydrate diet or Mediterranean diet or anti-inflammatory diet
- Active cancer or conditions limiting their ability to follow a diet (heart failure, end stage renal disease)
- Pregnancy, breastfeeding or planning to become pregnant during study period
- Use of Total Parenteral Nutrition at the time of screening and during the study period
- Other significant or life-threatening co-morbidities
- The need for antibiotic use during the study period
- Adults unable to consent
- Ages < 16 and > 75 years old
- Prisoners
- Crohn's specific complicated disease including active Stenotic (stricturing, B2) disease within the past 12 months, or Internal penetrating (B3) disease, or Draining perianal fistula, or Prior bowel resection
- Patients with concomitant Celiac disease
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Sequence A→B: Catered Anti-Inflammatory Diet Followed by Diet Guidance Group
Participants in this group will first receive an 8-week catered anti-inflammatory diet intervention, followed by a 2-week washout period, then an 8-week diet guidance period in which they consume their usual diet with weekly counseling focused on safe food preparation.
|
Participants will receive a fully catered anti-inflammatory diet for 8 weeks, with meals delivered twice weekly.
The diet is designed to provide >25 g fiber/day, a <3:1 n-6:n-3 fatty acid ratio, and <30% of total calories from fat, and excludes red meat, processed meats, fried foods, emulsifiers, artificial sweeteners, food colorings, and other ultra-processed ingredients.
Participants will also receive weekly remote sessions with a registered dietitian focused on dietary adherence, meal customization, grocery shopping, food affordability, and basic cooking skills.
Participants will continue consuming their self-selected usual diet for 8 weeks.
During this period, participants will receive weekly remote sessions with a registered dietitian focused on safe food handling, food preparation and cooking practices, and general nutrition education.
Participants will also receive grocery gift cards to support food purchasing and to maintain equivalent contact time and participant engagement across study periods.
No specific dietary pattern, food restrictions, or nutrient intake targets will be prescribed during this phase.
|
|
Experimental: Sequence B→A: Diet Guidance Followed by Catered Anti-Inflammatory Diet Group
Participants in this group will first receive an 8-week diet guidance period with weekly counseling while consuming their usual diet, followed by a 2-week washout period, then an 8-week catered anti-inflammatory diet intervention.
|
Participants will receive a fully catered anti-inflammatory diet for 8 weeks, with meals delivered twice weekly.
The diet is designed to provide >25 g fiber/day, a <3:1 n-6:n-3 fatty acid ratio, and <30% of total calories from fat, and excludes red meat, processed meats, fried foods, emulsifiers, artificial sweeteners, food colorings, and other ultra-processed ingredients.
Participants will also receive weekly remote sessions with a registered dietitian focused on dietary adherence, meal customization, grocery shopping, food affordability, and basic cooking skills.
Participants will continue consuming their self-selected usual diet for 8 weeks.
During this period, participants will receive weekly remote sessions with a registered dietitian focused on safe food handling, food preparation and cooking practices, and general nutrition education.
Participants will also receive grocery gift cards to support food purchasing and to maintain equivalent contact time and participant engagement across study periods.
No specific dietary pattern, food restrictions, or nutrient intake targets will be prescribed during this phase.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response
Zeitfenster: Baseline, Week 8, Week 10, Week 18
|
Clinical response is defined as a ≥70-point reduction from baseline in the Crohn's Disease Activity Index (CDAI).
The outcome is the percentage of participants who achieve this response following the dietary intervention.
|
Baseline, Week 8, Week 10, Week 18
|
|
Participants Achieving Fecal Calprotectin (FC) Reduction
Zeitfenster: Baseline, Week 8, Week 10, Week 18
|
Reduction is defined as a >50% decrease from baseline in fecal calprotectin (FC).
The outcome is the percentage of participants who achieve this reduction.
|
Baseline, Week 8, Week 10, Week 18
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission
Zeitfenster: Baseline, Week 8, Week 10, Week 18
|
Clinical Remission is defined as achieving a Crohn's Disease Activity Index (CDAI) score of <150.
The outcome is the percentage of participants who achieve this score.
|
Baseline, Week 8, Week 10, Week 18
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Oriana M Damas, MD, MSCTI, University of Miami
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. August 2026
Primärer Abschluss (Geschätzt)
1. August 2030
Studienabschluss (Geschätzt)
1. August 2030
Studienanmeldedaten
Zuerst eingereicht
22. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. Juni 2026
Zuerst gepostet (Tatsächlich)
26. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
26. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 20260433
- CDMRP-PR251962 (Andere Zuschuss-/Finanzierungsnummer: Defense Health Agency)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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