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Investigating the Effect of the Non-nutritive Sweetener Sucralose in Inflammatory Bowel Disease

Case Western Reserve University · with Crohn's and Colitis Foundation · NCT07852273

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
40
US sites recruiting
3
Study start
April 18, 2024
Record last updated
October 1, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Sucralose (non-nutritive sweetener)

Conditions: Inflamatory Bowel Disease; Crohn Disease (CD)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • UH Minoff Health Center

    Chagrin Falls, OH 44122

    Site contact: Abigail Basson, RD PhD · Abigail.Basson@uhhospitals.org

  • University Hospitals Cleveland Medical Center

    Cleveland, OH 44106

    Site contact: Abigail Basson, RD PhD · 1-888-844-8447 · Abigail.Basson@uhhospitals.org

  • UH Westlake Health Center

    Westlake, OH 44145

    Site contact: Abigail Basson, RD PhD · Abigail.Basson@uhhospitals.org

Study contacts (from the official record)

  • Sargun Singh, M.B.B.S. · 216-333-6085 · sks197@case.edu
  • Abigail Raffner, RD, PhD · 216-327-6003 · Abigail.Raffner@uhhospiatls.org
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Investigating the Effect of the Non-nutritive Sweetener Sucralose… (NCT07852273) | Bored Studies