ND-12 and H-6 combo for adults with chronic inflammatory diarrhea and ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase, randomized trial compares three treatment arms: mesalazine, ND-12, and ND-12 combined with H-6 in adults with active ulcerative colitis and chronic inflammatory diarrhea. Researchers will collect demographics, symptoms, medication use, and clinical outcomes, followed by a safety and efficacy follow-up period. The study aims to see if the ND-12/H-6 combination provides better symptom control and safety than standard therapy or ND-12 alone. Enrollment targets at least 36 participants who fit the inclusion criteria and meet no exclusion criteria. Outcomes will inform future development of this treatment approach.

Why it matters

Who can join: the full rules

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.

Exclusion Criteria:

Exclusion criteria related to chronic diarrhoea

1. Presence of any of the following symptoms:

   1. Fever ≥37.5°C;
   2. Moderate-to-severe dehydration requiring intravenous fluid replacement;
   3. Recurrent vomiting.
2. Diarrhoea caused by enteric pathogens (e.g., Clostridioides difficile, Salmonella typhi, etc.).
3. Underlying diseases that may trigger diarrhoea, including hyperthyroidism, gastrointestinal autonomic nervous dysfunction, gastrointestinal malignancy, 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
4. Suspected drug-induced diarrhoea (e.g., long-term use of laxatives, antibiotics, chemotherapeutic agents, etc.) where discontinuation of the offending drug is not feasible.
5. History of allergy to any component of mesalazine capsules, ND-12 capsules or H-6 capsules.
6. Anticipated need for prohibited medications during the study (e.g. antibiotics, antidiarrhoeals, antiemetics, antispasmodics, etc.).
7. Use of any investigational drug within 30 days prior to enrolment into this study.

   Other gastrointestinal exclusion criteria
8. History of gastrectomy or vagotomy.
9. Known malabsorptive disorders include coeliac disease.
10. Known lactose intolerance.
11. Any suspected condition requiring abdominal surgery. Other exclusion criteria
12. Confirmed human immunodeficiency virus (HIV) positive status, known or suspected immunosuppression.
13. Known severe hepatic or renal insufficiency.
14. Past or current history of alcohol abuse and/or known substance abuse (cocaine, heroin, cannabis, etc.).
15. Any psychiatric condition impairing the subject's ability to understand the nature, scope and potential consequences of the study, and/or documented evidence of non-cooperation.
16. Pregnant or lactating women.

Where it's running

• The Second Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Faming Zhang, PhD
• Email: fzhang@njmu.edu.cn
• Phone: 086-025-58509883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.