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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT02108821

NCT02108821
Completed Phase 1

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with Inflammatory Bowel Disease (IBD) — either Ulcerative Colitis (UC) or Crohn's Disease (CD)
  • If you have Ulcerative Colitis, your current treatment is not working well enough and your doctor needs to perform a scope of your stomach and colon to reassess and adjust your treatment
  • If you have Crohn's Disease affecting the large intestine or the area where the small and large intestines meet, your doctor needs to perform a scope of your stomach and colon because your disease is flaring or poorly controlled
  • You are healthy enough to safely undergo a colonoscopy procedure
  • Your Ulcerative Colitis activity score (PUCAI) is below 65, meaning your symptoms are not at the most severe level (confirm with trial site)
  • Your Crohn's Disease activity score (PCDAI) is below 40, meaning your symptoms are not at the most severe level (confirm with trial site)

Who may not be able to join:

  • You have Crohn's Disease with serious complications such as an abscess, blockage, perforation, abnormal connections between organs, or an active infection causing your flare-up
  • You are taking a high level of immune-suppressing medications — specifically, a biologic medication combined with steroid doses above 30mg per day
  • You have a central line (a tube inserted into a large vein for medical treatment)
  • You require machines to support your blood pressure or breathing
  • You are currently taking antibiotics
  • You are not willing to give consent or follow the study guidelines for the full duration of the trial
  • Your lab results, or those of the stool donor, show that the stool transplant procedure would not be safe or appropriate
  • Your doctor decides participation is not appropriate for you
  • You decide you no longer wish to take part

Regarding stool donors — donors cannot participate if they:

  • Have taken antibiotics in the last 3 months before donating
  • Have a personal history of any gut or digestive diseases
  • Have a history of autoimmune conditions, severe allergies, or take medications that affect the immune system
  • Have a history of chronic pain, neurological conditions, or developmental disorders
  • Have metabolic syndrome, are malnourished, or are obese
  • Have been exposed to infectious diseases
  • Have had diarrhea or signs of a gut infection within two weeks before, or on the day of, donation
  • Have a history of cancer or are currently receiving cancer treatment
  • Weigh less than 15 kg (approximately 33 pounds)

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.

Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 1
Sponsor
Children's Mercy Hospital Kansas City
Registry
clinicaltrials_gov
Start date
1 March 2014
Est. completion
30 September 2016

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of Occurrences of Adverse Events at 6 Months According to Adverse Event Term

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov