Recruiting

Sucralose

Sponsor:

Case Western Reserve University

Code:

NCT07852273

Conditions

Inflamatory Bowel Disease

Crohn Disease (CD)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Sucralose (non-nutritive sweetener)

Study Details

Brief summary:

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 Inflammatory Bowel Disease (IBD), compared to healthy non-IBD individuals. We will focus on studying IBD patients affected with Crohn's Disease (CD) as a proof of principle that could be tested later in other IBD subtypes (ulcerative colitis or others specific surgical conditions).

Conditions

Inflamatory Bowel Disease

Crohn Disease (CD)

Study ID

NCT07852273

Start date

Apr 18, 2024

Status verified date

Sep, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age range from 18 to 75 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 Irritable Bowel Disease 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 patient's cooperation.
  • Existing pregnancy or lactation
  • History of <1 natural bowel movements per 3 consecutive days
  • Unable to access technology that permits the daily completion of study related activities
  • Change in IBD medication within past 4 weeks
  • Body mass Index <16 kg/m or ≥40 kg/m
  • Documented C.difficile colitis within four weeks of screening
  • Bariatric surgery
  • Phenylketonuria

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Crohn's participants

Crohn's participants will consume the artificial sweetener sucralose

experimental: Healthy Controls

Healthy control participants will consume the artificial sweetener sucralose

Interventions

Sucralose (non-nutritive sweetener)

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.

Primary outcome measure

  • Change in fecal microbiome [ Time Frame: Baseline, 14 days post-baseline, and 21 days post-intervention ]

Central Contacts and Locations

Central contacts

Sargun Singh, M.B.B.S.

216-333-6085sks197@case.edu

Abigail Raffner, RD, PhD

216-327-6003Abigail.Raffner@uhhospiatls.org

Locations

UH Minoff Health Center

Recruiting

Chagrin Falls, Ohio, United States, 44122

Contacts

Abigail Basson, RD PhD

Abigail.Basson@uhhospitals.org

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Abigail Basson, RD PhD

1-888-844-8447Abigail.Basson@uhhospitals.org

UH Westlake Health Center

Recruiting

Westlake, Ohio, United States, 44145

Contacts

Abigail Basson, RD PhD

Abigail.Basson@uhhospitals.org

More Information

Sponsor

Case Western Reserve University

Last update posted

Oct 1, 2026

Last verified

Sep, 2026

Keywords

  • sweeteners
  • sucralose
  • inflammatory bowel disease
  • crohn's disease
  • IBD
  • CD
  • artificial sweeteners

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-02. This information was provided to ClinicalTrials.gov by Case Western Reserve University on 2026-10-01. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.