Non-nutritive Sweeteners in Inflammatory Bowel Disease
The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Participation in this study will last for a minimum of 35 days (Phase I: 14-days; baseline with removal of all NNS (eg saccharin, sucralose, steviosides, aspartame, acesulfame-k, erythritol) from the diet, Phase II: 21-days; sucralose intervention, and will involve one virtual visit (study visit 1) and two in-person study visits (study visit 2 and study visit 3).
Fecal & urine samples will be collected before/after each phase. Blood will also be collected.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Abigail Raffner, RD PhD
- Telefonnummer: 216-327-6003
- E-Mail: Abigail.Raffner@uhhospitals.org
Studieren Sie die Kontaktsicherung
- Name: Sargun Singh, M.B.B.S.
- Telefonnummer: 216-333-6085
- E-Mail: sargun.singh@uhhospitals.org
Studienorte
-
-
Ohio
-
Chagrin Falls, Ohio, Vereinigte Staaten, 44122
- Rekrutierung
- UH Minoff Health Center
-
Unterermittler:
- Jeffry Katz, MD
-
Kontakt:
- Abigail Basson, RD PhD
- E-Mail: Abigail.Basson@uhhospitals.org
-
Cleveland, Ohio, Vereinigte Staaten, 44106
- Rekrutierung
- University Hospitals Cleveland Medical Center
-
Unterermittler:
- Jeffry Katz, MD
-
Kontakt:
- Abigail Basson, RD PhD
- E-Mail: Abigail.Basson@uhhospitals.org
-
Unterermittler:
- Vu Nguyen, MD
-
Westlake, Ohio, Vereinigte Staaten, 44145
- Rekrutierung
- UH Westlake Health Center
-
Kontakt:
- Abigail Basson, RD PhD
- E-Mail: Abigail.Basson@uhhospitals.org
-
Unterermittler:
- Vu Nguyen, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
Age range from: 18 to 70 years. Male or female. Documented diagnosis of Crohns disease. CD outpatients in remission; Harvey Bradshaw- index in remission (<6 score).
Capable of providing consent to participate. Able to complete daily surveys and take oral nutrition. Able to record meal intake. Healthy controls with no diagnosis of IBD or Irritable Bowel Syndrome (IBS).
Exclusion Criteria:
Short bowel syndrome. Hospitalized patients. Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
Known drug abuse. Known parasitic disease of the digestive system. Symptomatic intestinal stricture/narrowing. Presence of an ostomy. Known active malignancy. Antibiotic use within last 14 days. Well-founded doubt about the patients cooperation. Existing pregnancy or lactation. History of <1 natural bowel movements per 3 consecutive days. Unable to access to technology that permits the daily completion of study related activities.
Change in IBD medication within past 4 weeks. Body mass Index <18 kg/m or ≥35 kg/m. Documented C.difficile colitis within four weeks of screening. Bariatric surgery Phenylketonuria
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Crohn's participants
Crohn's participants will consume artificial sweetener: sucralose
|
Participants will consume 2 sachets/day during the exposure period resulting in the following daily dose: sucralose 2.5mg/kg.
This dose is below the acceptable daily intakes (ADI) of 5mg/kg.
|
|
Experimental: Healthy Controls
Healthy control participants will consume artificial sweetener: sucralose
|
Participants will consume 2 sachets/day during the exposure period resulting in the following daily dose: sucralose 2.5mg/kg.
This dose is below the acceptable daily intakes (ADI) of 5mg/kg.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in fecal microbiome measured by metagenome analysis
Zeitfenster: Baseline, three weeks pre-intervention, and three weeks after intervention
|
Quantify the change in the fecal microbiome using metagenome analysis
|
Baseline, three weeks pre-intervention, and three weeks after intervention
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Fecal Myeloperoxidase activity (MPO)
Zeitfenster: Baseline, three weeks pre-intervention, three weeks post-intervention
|
Quantify the change in fecal MPO
|
Baseline, three weeks pre-intervention, three weeks post-intervention
|
|
Change in Fecal Calprotectin
Zeitfenster: Baseline, three weeks pre-intervention, three weeks post-intervention
|
Quantify the change in fecal calprotectin
|
Baseline, three weeks pre-intervention, three weeks post-intervention
|
|
Change in Crohn's Disease Activity Index (CDAI)
Zeitfenster: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
|
Quantify the change in Crohn's Disease Activity Index.
The Crohn's Disease Activity Index (CDAI) is a validated clinical instrument used to quantify Crohn's disease activity.
It evaluates 8 components over a 7-day period: number of liquid or very soft stools, severity of abdominal pain, general well-being, extraintestinal complications, use of antidiarrheal medications, presence of an abdominal mass, hematocrit levels, and body weight deviation.
Each component is multiplied by a specific weighting factor and summed to calculate a total score.
Total scores range from 0 to approximately 600 points, where lower scores indicate lower disease activity.
A score of <150 indicates clinical remission, while a score of >450 indicates severe disease.
A negative change from baseline indicates clinical improvement.
|
Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
|
|
Change in C-reactive protein (CRP)
Zeitfenster: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_
|
Quantify change in CRP
|
Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Fabio Cominelli, MD PhD, University Hospitals Cleveland Medical Center
- Hauptermittler: Abigail Raffner, RD PhD, Case Western Reserve University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STUDY20221141
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .