Trial results
AI generated results 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
According to the results reported on ClinicalTrials.gov, this trial (NCT00325078) enrolled 40 people across three groups: 8 in a Treatment Group, 7 in an Observation Group, and 25 healthy Control Volunteers. The trial was measuring two main things: the number of infections that occurred over one year, and changes in Crohn's disease activity (using a scoring tool called the Crohn's Disease Activity Index, or CDAI — a number-based scale where a higher score means more severe disease, a score below 150 is considered remission, and a drop of more than 70 points is considered a meaningful response). Not everyone finished the study — only 3 of the 8 treatment participants, 2 of the 7 observation participants, and 23 of the 25 control volunteers completed it. The reported data shows that over the course of the study, the Treatment Group recorded 5 infections, the Observation Group recorded 4 infections, and the Control Volunteers recorded 13 infections. For the CDAI scores, the reported data shows a series of measurements taken at different time points for the Treatment and Observation groups. The Treatment Group's scores across these time points were reported as approximately 114, 191, 330, 505, 516, and 96. The Observation Group's corresponding scores were approximately 18, 23, 53, 159, 267, and the final figure was not reported. No measurements were reported for the gut immune cell analysis outcome. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 12440767) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Crohn's Disease and Colitis Trial, Terminated
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
Group One (observation/sample collection):
- You have a confirmed diagnosis of Chronic Granulomatous Disease (CGD), a specific immune system condition.
- You have inflammatory bowel disease (IBD), confirmed by your medical history or by a camera examination of your gut.
- You are not pregnant or breastfeeding.
- You have your own doctor at home who manages your care.
- You are willing to provide samples (such as blood or tissue) to be stored for research.
Group Two (treatment with a medication):
- You have a confirmed diagnosis of CGD and IBD (as above), and you are currently experiencing symptoms.
- Your stool (poo) has been tested and shows no signs of certain infections or parasites.
- You are not pregnant or breastfeeding, and if you could become pregnant, you agree to use contraception throughout the study.
- You have had a chest scan (CT) within the last 3 months showing no signs of tuberculosis (TB).
- You have your own doctor at home and are willing to provide samples for storage.
Group Three (endoscopy research):
- You are aged 18 or older and weigh at least 15 kg (about 33 lbs).
- You are willing to have a camera examination of your upper and lower digestive tract, including small tissue samples taken for research.
- You are not pregnant.
- You are willing to provide samples for storage.
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.
Group One:
- You have any condition that the study doctor believes puts you at undue risk by taking part.
Group Two:
- You have any condition that the study doctor believes puts you at undue risk by taking part.
- You have a positive diagnosis for tuberculosis (TB).
- You have a history of TB, serious heart problems (such as heart failure or a heart attack in the last 12 months), unstable chest pain, a low platelet count, or uncontrolled high blood pressure.
- You currently have an active serious infection in your body or gut.
- You have Hepatitis B or C infection.
- You have signs of liver damage (confirm with trial site).
- You are pregnant or breastfeeding.
- You have had cancer within the last 10 years.
- You have certain immune system conditions such as HIV, or are receiving chemotherapy, which the study doctor feels could interfere with the research.
- You have a specific type of inflammatory disease related to a different part of the immune system (confirm with trial site).
- You currently have a blocked bowel, a hole in your bowel, or serious bleeding in your digestive tract.
- You have received a live vaccine within 4 weeks before starting the study, or may need one during the study.
- You are unwilling to complete the tests or procedures required by the study.
Group Three:
- You currently have an active infection in your body or gut that requires antibiotic treatment.
- You have any condition that the study doctor believes puts you at undue risk by taking part.
- You have certain immune system conditions such as HIV or are receiving chemotherapy, which the study doctor feels could interfere with the research.
- You are unwilling to complete the tests or procedures required by the study.
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.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial was run
These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.
Primary endpoints
Safety of Study Drug; Efficacy of Treatment With Study Drug
Other options
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.