Crohn's Disease and Colitis Trial, Recruiting NCT06895252 Sponsor: All India Institute of Medical Sciences Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT06895252
Recruiting Not Applicable

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:

  • People who have been diagnosed with ulcerative colitis (a type of bowel inflammation) and have not yet received treatment for it, regardless of how much of the bowel is affected (though people whose condition is limited to the lower end of the bowel — called proctitis — will make up no more than 25% of participants)
  • People whose disease is considered mild to moderate based on camera examination of the bowel (confirmed by specific scoring systems used by doctors)
  • People aged between 18 and 75 years
  • People who give their consent to receive a procedure called FMT (Faecal Microbiota Transplant, which involves transferring stool from a healthy donor)
  • People who agree to follow a specific diet plan during the trial
  • People who have been taking oral or topical aminosalicylate (ASA) medication for fewer than 4 weeks
  • People who have been taking oral or topical steroid medication for fewer than 1 week
  • People for whom infectious causes of bowel inflammation have been ruled out through biopsy results or two bowel examinations at least 7 days apart

Who may not be able to join:

  • People whose disease is classified as severe based on bowel examination scoring
  • People showing signs of very serious bowel conditions such as fulminant colitis or toxic megacolon (life-threatening forms of bowel inflammation)
  • People diagnosed with related but different bowel conditions, such as IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or Crohn's Disease
  • People who have already been on certain medications — such as biologics or immunosuppressants (including azathioprine, 6-mercaptopurine, or methotrexate) — for more than 2 weeks
  • People who need to be admitted to hospital
  • People who are pregnant or breastfeeding
  • People with serious, ongoing, or worsening conditions affecting the kidneys, liver, blood, gut, metabolism, hormones, lungs, heart, or nervous system
  • People whose stool tests come back positive for certain infections (such as parasites, bacteria, or a germ called Clostridioides difficile) — note that people who test positive may be treated first and retested; if the retest is negative and bowel inflammation is still present, joining the trial may still be considered (confirm with trial site)
  • People who are HIV positive

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 27 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: +91-9810707170

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
Not Applicable
Sponsor
All India Institute of Medical Sciences
Registry
ClinicalTrials.gov
Start date
15 March 2025
Est. completion
15 March 2027

Where this trial is recruiting

🇮🇳 India

Primary endpoints

Proportion of patients having clinical remission and endoscopic response at week 10; Proportion of patients having clinical remission and endoscopic response at week 48

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: 27 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