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Non-nutritive Sweeteners 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 70 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 with no calories, changes microbes living in the gut. It compares adults with Crohn’s disease, a type of inflammatory bowel disease (IBD), with healthy adults. Participants take 2 packets of sucralose each day.

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).

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

Eligibility

Who can join

  • Age 18 to 70, male or female.
  • Have a confirmed Crohn’s disease diagnosis, with symptoms under control and a Harvey-Bradshaw symptom score below 6; not staying in a hospital.
  • Healthy comparison participants must have no IBD or irritable bowel syndrome (IBS).
  • Able to understand and agree to join the study.
  • Able to complete daily surveys and record what you eat.
  • Able to take food or nutrition by mouth.

Who can't join

  • Short bowel syndrome, bowel narrowing that causes symptoms, or an ostomy (a surgery-made opening for waste to leave the body).
  • A known parasite infection in the gut, or confirmed C. difficile infection causing swelling in the colon within 4 weeks of screening.
  • Staying in a hospital; unable to understand and agree to join; a prisoner; or serious concerns about following study instructions.
  • Known drug abuse or active cancer.
  • Antibiotics in the past 14 days, or a change in IBD medicine in the past 4 weeks.
  • Pregnant or breastfeeding.
  • Fewer than 1 natural bowel movement over 3 days in a row, or no access to technology needed for daily study tasks.
  • Body mass index (BMI, a measure of weight compared with height) below 18 or 35 or higher; past weight-loss surgery; or phenylketonuria (a condition that prevents the body from breaking 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 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

Study sites (3)

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