Crohn's Disease and Colitis Trial, Not Yet Recruiting NCT07017959 Sponsor: University of South Florida Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Not Yet Recruiting

NCT07017959
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • Adults aged 18 years or older.
  • People who have a confirmed diagnosis of Inflammatory Bowel Disease (IBD) — a condition causing ongoing inflammation in the digestive tract.
  • People who have had IBD for more than 3 months.
  • People who have had a colonoscopy (a camera examination of the bowel) within the last 2 years before joining the study.
  • People who currently have mild to moderate IBD symptoms.
  • People who are able and willing to sign a consent form agreeing to take part.
  • People with a Body Mass Index (BMI) — a measure of body weight relative to height — between 18 and 40.
  • People who speak English.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have had major surgery on their digestive system (stomach, intestines, bowel) in the past.
  • People who have used antibiotics, or who have had diarrhoea or vomiting, in the past 30 days.
  • People who have used steroid medication given through a drip or injection (intravenous corticosteroids) within 2 weeks before or during the screening period, or at any point during the study.
  • People who have been diagnosed with cancer, or who have had chemotherapy or radiation treatment, within the past 2 years.
  • People whose weight has changed by more than 20 pounds (about 9 kilograms) in the past 2 weeks.
  • People who are currently using medications or treatments that are known to affect gut bacteria (the microbiome).
  • People who are currently taking part in another clinical trial.
  • People who are currently taking probiotic, prebiotic, synbiotic, or postbiotic supplements — though the trial site may allow participation if these products have been stopped for at least 30 days beforehand. (Note: probiotic use in this context means consuming 100 million or more live bacterial units per day, through tablets, capsules, lozenges, powders, or dairy products where probiotics are a main ingredient — confirm details with trial site.)
  • People who regularly eat more than 2 servings per day of yogurt, kefir, kombucha, or other fermented foods that may affect gut bacteria.
  • People who have heart disease, kidney disease, an active infection, a bleeding disorder affecting the gums, severe diabetes, a BMI over 40, a weakened immune system, or a thyroid disorder.
  • People who have a history of a severe allergic reaction (anaphylaxis) or known allergies to probiotics or postbiotics.
  • People whose behaviour or health conditions may make it difficult for them to follow the study procedures reliably.
  • People who belong to certain protected groups, including pregnant women, newborn babies, prisoners, and children.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 29 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: 813-974-6281

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
University of South Florida
Registry
ClinicalTrials.gov
Start date
15 June 2025
Est. completion
15 December 2025

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Levels of post-intervention fecal mucin (marker of gut barriers) between LpD3.5 and placebo groups

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 29 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov