Non-nutritive Sweeteners in Inflammatory Bowel Disease
The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Abigail Raffner, RD PhD
- Telefonnummer: 216-327-6003
- E-post: Abigail.Raffner@uhhospitals.org
Studera Kontakt Backup
- Namn: Sargun Singh, M.B.B.S.
- Telefonnummer: 216-333-6085
- E-post: sargun.singh@uhhospitals.org
Studieorter
-
-
Ohio
-
Chagrin Falls, Ohio, Förenta staterna, 44122
- Rekrytering
- UH Minoff Health Center
-
Underutredare:
- Jeffry Katz, MD
-
Kontakt:
- Abigail Basson, RD PhD
- E-post: Abigail.Basson@uhhospitals.org
-
Cleveland, Ohio, Förenta staterna, 44106
- Rekrytering
- University Hospitals Cleveland Medical Center
-
Underutredare:
- Jeffry Katz, MD
-
Kontakt:
- Abigail Basson, RD PhD
- E-post: Abigail.Basson@uhhospitals.org
-
Underutredare:
- Vu Nguyen, MD
-
Westlake, Ohio, Förenta staterna, 44145
- Rekrytering
- UH Westlake Health Center
-
Kontakt:
- Abigail Basson, RD PhD
- E-post: Abigail.Basson@uhhospitals.org
-
Underutredare:
- Vu Nguyen, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in fecal microbiome measured by metagenome analysis
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Fecal Myeloperoxidase activity (MPO)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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_
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Fabio Cominelli, MD PhD, University Hospitals Cleveland Medical Center
- Huvudutredare: Abigail Raffner, RD PhD, Case Western Reserve University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY20221141
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