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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit, 2 visits
  • Procedures mentioned: Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how sucralose, a sweetener, changes the mix of microbes in the gut. Participants take 2 packets a day. It compares adults with Crohn’s disease, a type of inflammatory bowel disease (IBD), with healthy adults without IBD.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 75 years old.
  • You have a confirmed diagnosis of Crohn’s disease that is in remission, meaning symptoms are quiet. Your Harvey-Bradshaw symptom score must be below 6, and you must not be staying in a hospital.
  • Or, you are a healthy comparison participant with no IBD or irritable bowel syndrome (IBS).
  • You can understand the study and agree to take part.
  • You can complete daily surveys and record what you eat.
  • You can take food or nutrition by mouth.

Who can't join

  • You have short bowel syndrome, narrowing of the intestines that causes symptoms, or an ostomy (a surgically made opening for waste).
  • You are in the hospital, cannot give informed consent, are a prisoner, have known drug abuse, or there is strong reason to doubt you can follow study tasks.
  • You have a known parasite infection in your digestive system, active cancer, or C. difficile infection of the colon documented within 4 weeks before screening.
  • You took antibiotics in the past 14 days or changed your IBD medicine in the past 4 weeks.
  • You are pregnant or breastfeeding.
  • You have a history of fewer than 1 natural bowel movement over 3 days in a row, or cannot access technology needed for daily study tasks.
  • Your body mass index (BMI), a measure based on height and weight, is below 16 or at least 40.
  • You have had weight-loss surgery or have phenylketonuria (a condition that affects how the body breaks down part of protein).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (3)

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