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Non-nutritive Sweeteners in Inflammatory Bowel Disease

University Hospitals Cleveland Medical Center · with Crohn's and Colitis Foundation · NCT07769437

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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 18–70 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
40
US sites recruiting
3
Study start
February 3, 2025
Record last updated
September 25, 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 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).

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 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

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 · 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)

  • Abigail Raffner, RD PhD · 216-327-6003 · Abigail.Raffner@uhhospitals.org
  • Sargun Singh, M.B.B.S. · 216-333-6085 · sargun.singh@uhhospitals.org
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Non-nutritive Sweeteners in Inflammatory Bowel Disease (NCT07769437) | Bored Studies