Non-nutritive Sweeteners in Inflammatory Bowel Disease
The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease
This study will focus on the commonly used non-nutritive sweetener (NNS) sucralose (2 sachets/day resulting in daily dose: sucralose 2.5mg/kg) and its role in changing the gut microbiota in humans with IBD, compared to healthy non-IBD individuals. The investigators will focus on studying IBD patients affected with CD as a proof of principle that could be tested later in other IBD subtype (ulcerative colitis or others specific surgical conditions).
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
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Unterermittler:
- Jeffry Katz, MD
-
Kontakt:
- Abigail Basson, RD PhD
- E-Mail: Abigail.Basson@uhhospitals.org
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Cleveland, Ohio, Vereinigte Staaten, 44106
- Rekrutierung
- University Hospitals Cleveland Medical Center
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Unterermittler:
- Jeffry Katz, MD
-
Kontakt:
- Abigail Basson, RD PhD
- E-Mail: Abigail.Basson@uhhospitals.org
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Unterermittler:
- Vu Nguyen, MD
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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
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
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
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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