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).
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
Tar emot friska volontärer
Kön som är behöriga för studier
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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