ND-12 Combined With H-6 for Adult Chronic Inflammatory Diarrhea

August 11, 2026 updated by: Faming Zhang, The Second Hospital of Nanjing Medical University

A Randomised, Controlled, Double-blind Exploratory Study of ND-12 Combined With H-6 in the Treatment of Adult Chronic Inflammatory Diarrhea

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesalazine
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
Take 4 melesalazine capsules each time, 3 times a day. Continue for 14 days.
Experimental: ND-12
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
Take 1 ND-12 capsule and 3 blank capsules each time, 3 times a day. Continue for 14 days
Experimental: ND-12/H-6
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 1 ND-12 capsule and 3 H-6 capsules each time, 3 times a day. Continue for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal calprotectin of patients 14 days after treatment compared to the baseline level
Time Frame: 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
baseline, 14 days post-drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of subjects who achieved a clinical response on the 14th day
Time Frame: 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)
14 days post-drug administration
The proportion of subjects achieving deep remission on the 14th day
Time Frame: 14 days post-drug administration
The proportion of subjects achieving deep remission on the 14th day (Fecal calprotectin < 100 μg/g)
14 days post-drug administration
Serum inflammatory factors after treatment
Time Frame: 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
baseline, 14 days post-drug administration
The frequency of defecation after treatment
Time Frame: 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;
baseline, 7 days post-drug administration, 14 days post-drug administration, and 28 days post-drug administration
The fecal consistency scores after treatment
Time Frame: 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;
baseline, 7 days post-drug administration, 14 days post-drug administration, and 28 days post-drug administration
The gastrointestinal symptom grading scores after treatment
Time Frame: 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
baseline, 7 days post-drug administration, 14 days post-drug administration, and 28 days post-drug administration
The changes of gut microbiome and metabolome
Time Frame: baseline, 7 days post-drug administration
Changes in the gut microbiome and metabolome of subjects on the 7th day compared with baseline
baseline, 7 days post-drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Hospital of Nanjing Medical University

Collaborators

Neurodawn Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2026

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

August 11, 2026

First Submitted That Met QC Criteria

August 11, 2026

First Posted (Actual)

August 17, 2026

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT-2026CMTS-ND12H6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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