Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT03847467 Sponsor: Children's Hospital Medical Center, Cincinnati Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT03847467
Recruiting Phase 2

Who may 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 might be able to join this trial:

  • You are willing and able to sign a consent form agreeing to take part in the study.
  • You are willing to follow all study procedures and can participate for the full length of the study.
  • You are male or female, between 11 and 25 years old.
  • You have been diagnosed with Crohn's Disease or Ulcerative Colitis.
  • Your condition is currently in remission (not actively flaring), as measured by specific scoring tools based on your age and diagnosis (confirm with trial site).
  • You are not currently taking corticosteroid medications (such as prednisone).
  • You have been on a stable dose of adalimumab, infliximab, or infliximab-dyyb for at least 12 weeks before joining the study.
  • If you take mesalamine, mercaptopurine, azathioprine, or methotrexate, your dose has been stable for at least 12 weeks before joining.
  • You agree not to make major changes to your diet during the study, such as switching to a vegan, Specific Carbohydrate Diet, or exclusive liquid nutrition diet.
  • If you have Crohn's Disease and had one bowel resection surgery involving only a limited part of the colon, and it was at least six months ago, you may still be eligible (confirm with trial site).

Who may not be able to join:

  • You have had an active flare-up of your IBD in the past six months.
  • You have used antibiotics, probiotics, or prebiotics in the past month.
  • You have been diagnosed with celiac disease, diabetes, or another condition that the study doctor determines makes participation unsafe.
  • You have taken part in another clinical trial or received an experimental treatment in the past 4 weeks.
  • You have received another biologic medication for IBD in the past 12 weeks.
  • You have difficulty digesting lactose (lactose intolerance).
  • You are currently pregnant or breastfeeding.
  • You have had more than one IBD-related surgery, or a surgery removing most of your colon (if you have Crohn's Disease), or any colonic surgery (if you have Ulcerative Colitis).
  • You are currently using anti-diarrheal medications.

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 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 1-(513)-636-1412

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
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
20 September 2019
Est. completion
30 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Mean Gastrointestinal Symptom Rating Scale (GSRS) in participants who receive 2'-fucosyllactose (2'FL) or dextrose placebo

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: 28 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