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

NCT07767370 | Recruiting Early Phase 1 DMC

• 1 other identifier: IIT-2026CMTS-ND12H6
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Diarrhea Chronic; UC - Ulcerative Colitis

Keywords

Chronic inflammatory diarrhea; Ulcerative colitis; Fecal calprotectin

Outcome Measures

Primary Outcomes (1)

• 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

  baseline, 14 days post-drug administration

Secondary Outcomes (7)

• The proportion of subjects who achieved a clinical response on the 14th day

  14 days post-drug administration

• The proportion of subjects achieving deep remission on the 14th day

  14 days post-drug administration

• Serum inflammatory factors after treatment

  baseline, 14 days post-drug administration

• The frequency of defecation after treatment

  baseline, 7 days post-drug administration, 14 days post-drug administration, and 28 days post-drug administration

• The fecal consistency scores after treatment

  baseline, 7 days post-drug administration, 14 days post-drug administration, and 28 days post-drug administration

Study Arms (3)

Mesalazine

EXPERIMENTAL

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

ND-12

EXPERIMENTAL

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

ND-12/H-6

EXPERIMENTAL

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

Interventions

mesalazine DRUG

Take 4 melesalazine capsules each time, 3 times a day. Continue for 14 days.

Mesalazine

ND-12 DRUG

Take 1 ND-12 capsule and 3 blank capsules each time, 3 times a day. Continue for 14 days

ND-12

ND-12/H-6 DRUG

Take 1 ND-12 capsule and 3 H-6 capsules each time, 3 times a day. Continue for 14 days

ND-12/H-6

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 18-75 years (inclusive), of any gender.
• Meet any one of the following conditions:
• ） 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).
• \. 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.

You may not qualify if:

• Presence of any of the following symptoms:
• Fever ≥37.5°C;
• Moderate-to-severe dehydration requiring intravenous fluid replacement;
• Recurrent vomiting.
• Diarrhoea caused by enteric pathogens (e.g., Clostridioides difficile, Salmonella typhi, etc.).
• 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.
• Suspected drug-induced diarrhoea (e.g., long-term use of laxatives, antibiotics, chemotherapeutic agents, etc.) where discontinuation of the offending drug is not feasible.
• History of allergy to any component of mesalazine capsules, ND-12 capsules or H-6 capsules.
• Anticipated need for prohibited medications during the study (e.g. antibiotics, antidiarrhoeals, antiemetics, antispasmodics, etc.).
• Use of any investigational drug within 30 days prior to enrolment into this study.
• History of gastrectomy or vagotomy.
• Known malabsorptive disorders include coeliac disease.
• Known lactose intolerance.
• Confirmed human immunodeficiency virus (HIV) positive status, known or suspected immunosuppression.
• Known severe hepatic or renal insufficiency.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead
• Neurodawn Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (9)

• Stevens TW, Gecse K, Turner JR, de Hertogh G, Rubin DT, D'Haens GR. Diagnostic Accuracy of Fecal Calprotectin Concentration in Evaluating Therapeutic Outcomes of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2333-2342. doi: 10.1016/j.cgh.2020.08.019. Epub 2020 Aug 13.

  PMID: 32801008 RESULT

• Ben-Horin S, Salomon N, Karampekos G, Viazis N, Lahat A, Ungar B, Eliakim R, Kuperstein R, Kriger-Sharabi O, Reiss-Mintz H, Yanai H, Dotan I, Zittan E, Maharshak N, Hirsch A, Weitman M, Mantzaris GJ, Kopylov U. Curcumin-QingDai Combination for Patients With Active Ulcerative Colitis: A Randomized, Double-Blinded, Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2024 Feb;22(2):347-356.e6. doi: 10.1016/j.cgh.2023.05.023. Epub 2023 Jun 9.

  PMID: 37302449 RESULT

• Elmore AR; Cosmetic Ingredient Review Expert Panel. Final report on the safety assessment of aluminum silicate, calcium silicate, magnesium aluminum silicate, magnesium silicate, magnesium trisilicate, sodium magnesium silicate, zirconium silicate, attapulgite, bentonite, Fuller's earth, hectorite, kaolin, lithium magnesium silicate, lithium magnesium sodium silicate, montmorillonite, pyrophyllite, and zeolite. Int J Toxicol. 2003;22 Suppl 1:37-102.

  PMID: 12851164 RESULT

• Wang N, Zhang M, Yang M, Liu W, Liu W, Ou Y, Zhou M, Wang X, Sun Z, Pan Y, Wang Y, Wang Y. Efficacy and safety of Y-3 intracalvariosseous injection versus intravenous injection in the treatment of acute large hemispheric infarction (SOLUTION-2): rationale and design of a multicentre, prospective, randomised, open-label, blind endpoint (PROBE) trial. Stroke Vasc Neurol. 2026 Mar 4;11(1):130-135. doi: 10.1136/svn-2024-004011.

  PMID: 40461153 RESULT

• GBD 2021 Diarrhoeal Diseases Collaborators. Global, regional, and national age-sex-specific burden of diarrhoeal diseases, their risk factors, and aetiologies, 1990-2021, for 204 countries and territories: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Infect Dis. 2025 May;25(5):519-536. doi: 10.1016/S1473-3099(24)00691-1. Epub 2024 Dec 18.

  PMID: 39708822 RESULT

• Sultana R, Luby SP, Gurley ES, Rimi NA, Swarna ST, Khan JAM, Nahar N, Ghosh PK, Howlader SR, Kabir H, Khan S, Jensen PKM. Cost of illness for severe and non-severe diarrhea borne by households in a low-income urban community of Bangladesh: A cross-sectional study. PLoS Negl Trop Dis. 2021 Jun 11;15(6):e0009439. doi: 10.1371/journal.pntd.0009439. eCollection 2021 Jun.

  PMID: 34115764 RESULT

• GBD 2021 Causes of Death Collaborators. Global burden of 288 causes of death and life expectancy decomposition in 204 countries and territories and 811 subnational locations, 1990-2021: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2024 May 18;403(10440):2100-2132. doi: 10.1016/S0140-6736(24)00367-2. Epub 2024 Apr 3.

  PMID: 38582094 RESULT

• GBD 2016 Diarrhoeal Disease Collaborators. Estimates of the global, regional, and national morbidity, mortality, and aetiologies of diarrhoea in 195 countries: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Infect Dis. 2018 Nov;18(11):1211-1228. doi: 10.1016/S1473-3099(18)30362-1. Epub 2018 Sep 19.

  PMID: 30243583 RESULT

• Schiller LR, Pardi DS, Sellin JH. Chronic Diarrhea: Diagnosis and Management. Clin Gastroenterol Hepatol. 2017 Feb;15(2):182-193.e3. doi: 10.1016/j.cgh.2016.07.028. Epub 2016 Aug 2.

  PMID: 27496381 RESULT

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Mesalamine

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

meta-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Aminosalicylic Acids; Salicylates; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Central Study Contacts

Faming Zhang, PhD

CONTACT

086-025-58509883; fzhang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 17, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)