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CMTS0929 for Inflammatory Bowel Disease

ConditionInflammatory Bowel Disease (IBD)
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Second Hospital of Nanjing Medical University

About this trial

This is a prospective, open-label, single-arm study to explore the safety and the efficacy of China Microbiota Transplantation System 0929 (CMTS0929) for patients with inflammatory bowel disease (IBD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with inflammatory bowel disease (IBD) based on typical clinical symptoms, endoscopic findings, and histological criteria.

Aged between 18 and 75 years old, regardless of gender.

No history of using antibiotics, prebiotics, or probiotics within at least the past month.

Patients who can fully understand the content of the informed consent form for this trial and voluntarily sign the written informed consent.

Disqualifiers

Women who are pregnant or plan to become pregnant during the trial.

Patients who have any doubts about this technology or have a history of other risks.

Patients in the terminal stage of the disease or who may die during the study.

Patients with a history of antibiotic use within three months before transplantation or who have participated in other clinical trials.

Trial design

Design model

Single group

Treatments tested in this trial

  • CMTS0929

    Biological/Vaccine

    China Microbiota Transplantation System 0929 (CMTS0929) is defined as suspension from washed microbiota.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The efficacy of China Microbiota Transplantation System 0929 (CMTS0929)

Partial Mayo scale for Ulcerative Colitis (UC), the minimum score is 0, the score ≤2 and no single sub-score was \>1 is clinical remission, 3-5 as mild activity, 6-10 as moderate activity, 11-12 as severe activity.

Time frame
Four-week
2

The efficacy of China Microbiota Transplantation System 0929 (CMTS0929)

Crohn disease activity index (CDAI) for Crohn's disease (CD), the minimum value is 0, ≤ 4 is remission，5-7 is mild，8-16 is moderate, \> 16 is severe, higher scores mean a worse outcome.

Time frame
Four-week

Secondary outcomes

1

The changes in endoscopic score

Time frame
Three-month, Six-month
2

The change in hematochezia compared with baseline

Hematochezia can be evaluated by Fecal occult blood test (FOBT) and the record of gross blood stool. The frenquence of hematochezia should be recorded.

Time frame
One-week, Four-week, Twelve-week, Six-month
3

The change in frequency of defecation compared with baseline

The frequency of defecation per day should be recorded.

Time frame
One-week, Four-week, Twelve-week, Six-month
4

The change in abdominal pain compared with baseline

The abdominal pain should be recorded, such as 0 for none, 1 for mild, 2 for moderate, 3 for severe, 4 for very severe.

Time frame
One-week, Four-week, Twelve-week, Six-month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Second Hospital of Nanjing Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: