Non-nutritive Sweeteners in Inflammatory Bowel Disease

NCT07769437 | Recruiting DMC

• 1 other identifier: STUDY20221141
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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 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).

Conditions

Inflamatory Bowel Disease; Crohn Disease (CD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in fecal microbiome measured by metagenome analysis

  Quantify the change in the fecal microbiome using metagenome analysis

  Baseline, three weeks pre-intervention, and three weeks after intervention

Secondary Outcomes (4)

• Change in Fecal Myeloperoxidase activity (MPO)

  Baseline, three weeks pre-intervention, three weeks post-intervention

• Change in Fecal Calprotectin

  Baseline, three weeks pre-intervention, three weeks post-intervention

• Change in Crohn's Disease Activity Index (CDAI)

  Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)

• Change in C-reactive protein (CRP)

  Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)

Study Arms (2)

Crohn's participants

EXPERIMENTAL

Crohn's participants will consume artificial sweetener: sucralose

Other: Sucralose (non-nutritive sweetener)

Healthy Controls

EXPERIMENTAL

Healthy control participants will consume artificial sweetener: sucralose

Other: Sucralose (non-nutritive sweetener)

Interventions

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.

Crohn's participants; Healthy Controls

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Crohn's and Colitis Foundation: collaborator

Study Sites (3)

UH Minoff Health Center

Chagrin Falls, Ohio, 44122, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

UH Westlake Health Center

Westlake, Ohio, 44145, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

trichlorosucrose

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Fabio Cominelli, MD PhD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Abigail Raffner, RD PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Raffner, RD PhD

CONTACT

216-327-6003; Abigail.Raffner@uhhospitals.org

Sargun Singh, M.B.B.S.

CONTACT

216-333-6085; sargun.singh@uhhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two groups; Crohn's and Healthy participants who undergo the same intervention

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 18, 2026
• Study Start: February 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)