Diarrhea Chronic, UC - Ulcerative Colitis
Conditions
Keywords
Chronic inflammatory diarrhea, Ulcerative colitis, Fecal calprotectin
Brief summary
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
Detailed description
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.
Interventions
DRUGmesalazine
Take 4 melesalazine capsules each time, 3 times a day. Continue for 14 days.
DRUGND-12
Take 1 ND-12 capsule and 3 blank capsules each time, 3 times a day. Continue for 14 days
DRUGND-12/H-6
Take 1 ND-12 capsule and 3 H-6 capsules each time, 3 times a day. Continue for 14 days
Sponsors
The Second Hospital of Nanjing Medical University
Neurodawn Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects aged 18-75 years (inclusive), of any gender. 2. Meet any one of the following conditions: 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 informed consent 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal calprotectin of patients 14 days after treatment compared to the baseline level | baseline, 14 days post-drug administration | The rate of change in fecal calprotectin levels of the subjects at 14 days compared to the baseline level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The changes of gut microbiome and metabolome | baseline, 7 days post-drug administration | Changes in the gut microbiome and metabolome of subjects on the 7th day compared with baseline |
| The proportion of subjects who achieved a clinical response on the 14th day | 14 days post-drug administration | 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) |
| The proportion of subjects achieving deep remission on the 14th day | 14 days post-drug administration | The proportion of subjects achieving deep remission on the 14th day (Fecal calprotectin \< 100 μg/g) |
| Serum inflammatory factors after treatment | baseline, 14 days post-drug administration | 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 |
| The frequency of defecation after treatment | baseline, 7 days post-drug administration, 14 days post-drug administration, and 28 days post-drug administration | The situation of the subjects' defecation frequency on the 7th, 14th, and 28th days compared to the baseline; |
| The gastrointestinal symptom grading scores after treatment | baseline, 7 days post-drug administration, 14 days post-drug administration, and 28 days post-drug administration | The gastrointestinal symptom grading scores (using the GSRS scoring scale) of subjects on the 7th, 14th, and 28th days compared with the baseline values |
| The fecal consistency scores after treatment | baseline, 7 days post-drug administration, 14 days post-drug administration, and 28 days post-drug administration | 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; |
Countries
China
Contacts
CONTACTFaming Zhang, PhD
Outcome results
None listed