Crohn's Disease and Colitis Trial, Recruiting NCT06906445 Sponsor: All India Institute of Medical Sciences Condition: Crohn's Disease and Colitis
Back to Crohns Disease And Colitis

Crohn's Disease and Colitis Trial, Recruiting

NCT06906445
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:

  • Adults between 18 and 75 years old
  • People who have been diagnosed with active ulcerative colitis (UC), confirmed by both a camera examination of the bowel and tissue samples, with results showing a certain level of disease activity (confirm with trial site for specific score thresholds)
  • People whose UC affects any part of the large bowel — though those with disease limited only to the rectum will be capped at 25% of the total number of participants
  • People whose UC has not responded well to, stopped responding to, or who could not tolerate standard treatments — such as anti-inflammatory bowel medications, steroids, immune-suppressing drugs, or newer targeted therapies — with the last dose of any such treatment taken far enough in advance of joining the trial (confirm with trial site for exact timing)
  • People whose infectious causes of bowel symptoms have been ruled out, with bowel scope findings confirming ongoing UC activity
  • People who are willing and able to follow the treatment plan, keep a daily bowel movement diary, attend required appointments, and complete other study procedures
  • People who are willing to give written consent to receive a fecal microbiota transplant (FMT), a procedure involving donated stool material
  • People who agree to follow a specific diet schedule outlined by the trial

Who may not be able to join:

  • People who have been hospitalised for a severe flare of UC requiring intravenous (drip) steroids
  • People who have already been taking certain targeted therapies — specifically biologic medications (such as anti-TNF drugs) or a small molecule drug called tofacitinib — for two weeks or more
  • People showing signs of a very severe, dangerous form of colitis, including a serious complication called toxic megacolon
  • People who test positive at screening for bowel infections caused by bacteria, parasites, a germ called Clostridioides difficile, or a virus called CMV (though people who are treated successfully and retest negative may still be considered)
  • People with an active or inadequately treated infection, including tuberculosis
  • People whose bowel condition is classified as something other than UC — such as an unclassified inflammatory bowel disease, microscopic colitis, bowel inflammation caused by reduced blood flow, infectious colitis, or findings that suggest Crohn's disease
  • People living with HIV
  • People with a current or past history of cancer
  • People with serious, progressive, or poorly controlled conditions affecting the kidneys, liver, blood, digestive system, metabolism, hormones, lungs, heart, or nervous system
  • People who are pregnant

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 26 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

Principal Investigator: Prof Vineet Ahuja, DM Gastroenterology, Department of Gastroenterology, AIIMS, New Delhi

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 Achieving Clinical Remission and Endoscopic Response at 10 weeks; Proportion of patients having clinical remission and endoscopic remission 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: 26 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