An Early Phase 1 interventional study of mesalazine and ND-12 in Diarrhea Chronic and UC - Ulcerative Colitis, sponsored by The Second Hospital of Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by The Second Hospital of Nanjing Medical University · Early Phase 1, Interventional, and Treatment
This is a randomized controlled trial to explore the efficacy and safety of ND-12 combined with H-6 for patients with chronic inflammatory diarrhea
At least 36 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. They will be randomly assigned to the mesalazine group , ND-12, and the ND-12/H-6 group. Data of demographic characteristics, intestinal symptoms, medicine treatment usage and clinical outcomes will be collected. After treatment, they will enter the follow-up period for efficacy and safety evaluation.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 36 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →The Second Hospital of Nanjing Medical University is the lead sponsor of 70 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
1） Previously diagnosed ulcerative colitis, currently in the active phase; 2） Diagnosis of chronic diarrhoea: stool frequency ≥3 times per day or markedly higher than the subject's usual baseline; disease duration >4 weeks; recurrent diarrhoea with an interval of 2-4 weeks between episodes; loose stools (Bristol Stool Form Scale type 5, 6, or 7).
3. Faecal calprotectin >150 μg/g. 4.The subject or their legal representative provides by voluntarily signing the informed consent form, fully understands the study objectives, maintains effective communication with investigators, and is capable of understanding and complying with all requirements specified in this study protocol.
Exclusion Criteria:
Exclusion criteria related to chronic diarrhoea
Presence of any of the following symptoms:
Underlying diseases that may trigger diarrhoea, including hyperthyroidism, gastrointestinal autonomic nervous dysfunction, gastrointestinal , Crohn's disease, history of colectomy (appendectomy, haemorrhoid surgery and fistula-in-ano surgery excluded), history of small-bowel resection (>20 cm of resected intestinal segment), etc.
Drug-related exclusion criteria
Use of any drug within 30 days prior to enrolment into this study.
Other gastrointestinal exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible subjects meeting all inclusion criteria and none of the exclusion criteria randomized to this sequence will receive Mesalazine interventions at three separate time points over one day
Drug: mesalazine
Eligible subjects meeting all inclusion criteria and none of the exclusion criteria randomized to this sequence will receive ND-12 interventions at three separate time points over one day
Drug: ND-12
Eligible subjects meeting all inclusion criteria and none of the exclusion criteria randomized to this sequence will receive ND-12 and H-6 interventions at three separate time points over one day
Drug: ND-12/H-6
Take 4 melesalazine capsules each time, 3 times a day. Continue for 14 days.
Take 1 ND-12 capsule and 3 blank capsules each time, 3 times a day. Continue for 14 days
Take 1 ND-12 capsule and 3 H-6 capsules each time, 3 times a day. Continue for 14 days
Fecal calprotectin of patients 14 days after treatment compared to the baseline level
The rate of change in fecal calprotectin levels of the subjects at 14 days compared to the baseline level
Time frame: baseline, 14 days post-drug administration
The proportion of subjects who achieved a clinical response on the 14th day
The proportion of subjects who achieved a clinical response on the 14th day(Fecal calprotectin decreased by ≥50% compared to the baseline or returned to normal \<150 μg/g)
Time frame: 14 days post-drug administration
The proportion of subjects achieving deep remission on the 14th day
The proportion of subjects achieving deep remission on the 14th day (Fecal calprotectin \< 100 μg/g)
Time frame: 14 days post-drug administration
Serum inflammatory factors after treatment
The changes in inflammatory factors (IL-1β, IL-10, TNF-α) in the blood of the subjects at 14 days compared to the baseline level
Time frame: baseline, 14 days post-drug administration
The frequency of defecation after treatment
The situation of the subjects' defecation frequency on the 7th, 14th, and 28th days compared to the baseline;
Time frame: baseline, 7 days post-drug administration, 14 days post-drug administration, and 28 days post-drug administration
The fecal consistency scores after treatment
The changes in the fecal consistency scores (measured using the Bristol Fecal Form Scale) of subjects on the 7th, 14th, and 28th days compared to the baseline;
Time frame: baseline, 7 days post-drug administration, 14 days post-drug administration, and 28 days post-drug administration
The gastrointestinal symptom grading scores after treatment
The gastrointestinal symptom grading scores (using the GSRS scoring scale) of subjects on the 7th, 14th, and 28th days compared with the baseline values
Time frame: baseline, 7 days post-drug administration, 14 days post-drug administration, and 28 days post-drug administration
The changes of gut microbiome and metabolome
Changes in the gut microbiome and metabolome of subjects on the 7th day compared with baseline
Time frame: baseline, 7 days post-drug administration
Plan to share: No
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Studies of the drug tested here: Mesalamine
The Second Hospital of Nanjing Medical University