Diarrhea ChronicEarly Phase 1NCT07767370
ND-12 Combined With H-6 for Adult Chronic Inflammatory Diarrhea
A Early Phase 1 study testing mesalazine, ND-12 and ND-12/H-6 in people with Diarrhea Chronic and UC - Ulcerative Colitis, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diarrhea Chronic, UC - Ulcerative Colitis
- What is being tested?
- mesalazine, ND-12 and ND-12/H-6
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2026to 31 Aug 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18-75 years (inclusive), of any gender.
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- Drug-related exclusion criteria
- 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.
- Other gastrointestinal exclusion criteria
- History of gastrectomy or vagotomy.
- Known malabsorptive disorders include coeliac disease.
- Known lactose intolerance.
- Any suspected condition requiring abdominal surgery. Other exclusion criteria
- Confirmed human immunodeficiency virus (HIV) positive status, known or suspected immunosuppression.
- Known severe hepatic or renal insufficiency.
- Past or current history of alcohol abuse and/or known substance abuse (cocaine, heroin, cannabis, etc.).
- 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.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Faming Zhang, PhD, 086-025-58509883, fzhang@njmu.edu.cn
About this study
Official title: 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
Read the 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.
- Conditions
- Diarrhea Chronic, UC - Ulcerative Colitis
- Being tested
- mesalazine, ND-12, ND-12/H-6
- Keywords
- Chronic inflammatory diarrhea, Ulcerative colitis, Fecal calprotectin
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mesalazineDrug
Take 4 melesalazine capsules each time, 3 times a day. Continue for 14 days.
ND-12Drug
Take 1 ND-12 capsule and 3 blank capsules each time, 3 times a day. Continue for 14 days
ND-12/H-6Drug
Take 1 ND-12 capsule and 3 H-6 capsules each time, 3 times a day. Continue for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: ND-12/H-6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 14 days post-drug administration
Secondary outcomes (7)
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)
Measured: 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)
Measured: 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
Measured: 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;
Measured: 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;
Measured: 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
Measured: 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
Measured: baseline, 7 days post-drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start20 Jul 2026
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diarrhea ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Neurodawn Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767370
- Sponsor's protocol ID
- IIT-2026CMTS-ND12H6
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32801008Ben-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.
PubMed 37302449Elmore 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.
PubMed 12851164Wang 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.
PubMed 40461153GBD 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.
PubMed 39708822Sultana 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.
PubMed 34115764GBD 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.
PubMed 38582094GBD 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.
PubMed 30243583Schiller 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.
PubMed 27496381
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Double-blind Exploratory Study of ND-12 Combined With H-6 in the Treatment of Adult Chronic Inflammatory Diarrhea
- ClinicalTrials.gov ID
- NCT07767370
- Acronym / sponsor ID
- IIT-2026CMTS-ND12H6
- Conditions
- Diarrhea Chronic, UC - Ulcerative Colitis
- Keywords
- Chronic inflammatory diarrhea, Ulcerative colitis, Fecal calprotectin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Neurodawn Pharmaceutical Co., Ltd.
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mesalazine | Experimental | Drug: mesalazineEligible 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 |
| ND-12 | Experimental | Drug: ND-12Eligible 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 |
| ND-12/H-6 | Experimental | Drug: ND-12/H-6Eligible 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged 18-75 years (inclusive), of any gender.
- 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.
Key exclusion criteria (21 listed)
- Presence of any of the following symptoms:
- 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.
- Drug-related exclusion criteria
- Suspected drug-induced diarrhoea (e.g., long-term use of laxatives, antibiotics, chemotherapeutic agents, etc.) where discontinuation of the offending drug is not feasible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mesalazineTake 4 melesalazine capsules each time, 3 times a day. Continue for 14 days. | Drug | Mesalazine |
| ND-12Take 1 ND-12 capsule and 3 blank capsules each time, 3 times a day. Continue for 14 days | Drug | ND-12 |
| ND-12/H-6Take 1 ND-12 capsule and 3 H-6 capsules each time, 3 times a day. Continue for 14 days | Drug | ND-12/H-6 |
Primary outcome
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
7 secondary outcomes
The proportion of subjects who achieved a clinical response on the 14th day
Time frame: 14 days post-drug administration
The proportion of subjects achieving deep remission on the 14th day
Time frame: 14 days post-drug administration
Serum inflammatory factors after treatment
Time frame: 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 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 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 changes of gut microbiome and metabolome
Time frame: baseline, 7 days post-drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Results publication: PubMed 32801008Stevens 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.
- Results publication: PubMed 37302449Ben-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.
- Results publication: PubMed 12851164Elmore 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.
- Results publication: PubMed 40461153Wang 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.
- Results publication: PubMed 39708822GBD 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.
- Results publication: PubMed 34115764Sultana 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.
- Results publication: PubMed 38582094GBD 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.
- Results publication: PubMed 30243583GBD 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.
- Results publication: PubMed 27496381Schiller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing mesalazine, ND-12 and ND-12/H-6 in people with Diarrhea Chronic and UC - Ulcerative Colitis, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Faming Zhang, PhD (086-025-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal calprotectin of patients 14 days after treatment compared to the baseline level (time frame: baseline, 14 days post-drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07767370, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.