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

NCT07852273 | Recruiting DMC

• 1 other identifier: 20221141
• 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 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)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in fecal microbiome

  Quantify the change in the fecal microbiome as measured by metagenome analysis

  Baseline, 14 days post-baseline, and 21 days post-intervention

Secondary Outcomes (5)

• Change in Fecal Myleoperoxidase activity (MPO)

  Baseline, 14 days post-baseline, and 21 days post-intervention

• Change in Fecal Calprotectin

  Baseline, 14 days post-baseline, and 21 days post-intervention

• Change in Short Crohn's Disease Activity Index (sCDAI)

  Baseline, 14 days post-baseline, and 21 days post-intervention

• Change in Crohns Disease Activity Index (CDAI)

  Baseline, 14 days post-baseline, and 21 days post-intervention

• Change in C-reactive protein (CRP)

  14 days post-baseline and 21 days post-intervention

Study Arms (2)

Crohn's participants

EXPERIMENTAL

Crohn's participants will consume the artificial sweetener sucralose

Other: Sucralose (non-nutritive sweetener)

Healthy Controls

EXPERIMENTAL

Healthy control participants will consume the 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 - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

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 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

Sponsors & Collaborators

• Crohn's and Colitis Foundation: collaborator
• Case Western Reserve University: lead

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

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Abigal Raffner, PhD, RD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sargun Singh, M.B.B.S.

CONTACT

216-333-6085; sks197@case.edu

Abigail Raffner, RD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start: April 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)