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Tailored Anti-Inflammatory American Diet for Patients With Crohn's Disease

22. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

122

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

  • Navn: Eytan I Stern, MS, RD, LD/N, CNSC
  • Telefonnummer: 305-243-6405
  • E-mail: eis43@miami.edu

Studiesteder

  • Forenede Stater
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami
        • Kontakt:
          • Eytan I Stern, MS, RD, LD/N, CNSC
          • Telefonnummer: 305-243-6405
          • E-mail: eis43@miami.edu

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: Catered Anti-Inflammatory Diet
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.
Adfærdsmæssigt: Diet Guidance for Usual Diet
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.
Eksperimentel: 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.
Adfærdsmæssigt: Catered Anti-Inflammatory Diet
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.
Adfærdsmæssigt: Diet Guidance for Usual Diet
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Remission
Tidsramme: 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

Samarbejdspartnere og efterforskere

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

Sponsor

University of Miami

Samarbejdspartnere

United States Department of Defense

Efterforskere

  • Ledende efterforsker: Oriana M Damas, MD, MSCTI, University of Miami

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 (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2030

Studieafslutning (Anslået)

1. august 2030

Datoer for studieregistrering

Først indsendt

22. juni 2026

Først indsendt, der opfyldte QC-kriterier

22. juni 2026

Først opslået (Faktiske)

26. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20260433
  • CDMRP-PR251962 (Andet bevillings-/finansieringsnummer: Defense Health Agency)

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Crohns sygdom, aktiv

Kliniske forsøg med Catered Anti-Inflammatory Diet

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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