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NCT Number: NCT07769437

Non-nutritive 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. We 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).

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Key information

Conditions

Inflamatory Bowel Disease Crohn Disease Crohn Disease (CD) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Minoff Health Center, Chagrin Falls, Ohio, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sucralose (non-nutritive sweetener)

Other

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 outcomes

  1. Change in fecal microbiome measured by metagenome analysis

    Time frame: Baseline, three weeks pre-intervention, and three weeks after intervention

    Quantify the change in the fecal microbiome using metagenome analysis

Secondary outcomes

  1. Change in Fecal Myeloperoxidase activity (MPO)

    Time frame: Baseline, three weeks pre-intervention, three weeks post-intervention

    Quantify the change in fecal MPO

  2. Change in Fecal Calprotectin

    Time frame: Baseline, three weeks pre-intervention, three weeks post-intervention

    Quantify the change in fecal calprotectin

  3. Change in Crohn's Disease Activity Index (CDAI)

    Time frame: 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.

  4. Change in C-reactive protein (CRP)

    Time frame: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_

    Quantify change in CRP

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail Raffner, RD PhD

CONTACT

[email protected]

216-327-6003

Sargun Singh, M.B.B.S.

CONTACT

[email protected]

216-333-6085

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Crohn's and Colitis Foundation

Registry information

Official study title

The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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