ConstipationPhase 1/2NCT06832137
CMTS4520 for Chronic Constipation in Adults
A Phase 1/2 study testing CMTS4520 (dietary fiber probiotics) in people with Constipation, 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 CMTS4520 (Dietary Fiber Probiotics) for patients with chronic constipation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Constipation
- What is being tested?
- CMTS4520 (dietary fiber probiotics)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to 1 Jun 2030
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- Meet all of the following inclusion criteria :
- Voluntary sign informed consent, age 18-70 years old (including the threshold), male and female.
- For subjects diagnosed with chronic constipation, the duration of the disease is at least 6 months, and meet the following criteria:
- Frequency of spontaneous defecation <3 times/week (spontaneous defecation refers to spontaneous defecation without the aid of remedial purgatives or manual assistance).
- Dry and hard stool: More than a quarter of the stool is type 1 or 2 on the Bristol Fecal Trait Scale.
- The subject or his/her legal representative has given informed consent, is fully aware of the purpose of the study, is able to communicate well with the investigator, and is able to understand and comply with the requirements of the study.
Who cannot join
- -
- All exclusion criteria below are not met:
- Participants with outlet obstruction constipation, such as rectal mucosal prolapse.
- Participants with a history of intestinal resection.
- Participants with intestinal stenosis caused by organic lesions of the digestive tract (e.g., tumor, inflammation, anal fissures, Crohn's disease, ulcerative colitis, radiation enteritis, intestinal adhesions, intestinal tuberculosis) as confirmed by colonoscopy within the past 24 months.
- Participants with constipation secondary to systemic diseases affecting the digestive tract, including:
Show all 34Show fewer
- Neurological diseases (e.g., Parkinson's disease, spinal cord injury, multiple sclerosis).
- Muscle diseases (e.g., amyloidosis, dermatomyositis).
- Psychiatric disorders or severe mood disorders (e.g., A Hospital Anxiety and Depression Scale score ≥15).
- Opioid-induced constipation.
- Poorly controlled metabolic diseases (e.g., thyroid dysfunction) or metabolic diseases with gastrointestinal complications (e.g., gastrointestinal autonomic dysfunction, diabetic gastroparesis).
- Have a history of major surgery or severe trauma within 3 months and have not fully recovered.
- Participants with any of the following cardiac abnormalities:
- New York Heart Association (NYHA) Class III or higher heart failure.
- Myocardial infarction or unstable angina within the past 6 months.
- Prolonged QTc interval on electrocardiogram (≥450ms for males, ≥470ms for females).
- Atrial arrhythmias that cannot be stably controlled by drugs and ventricular arrhythmias requiring pharmacological control (including grade 2 or higher atrioventricular block).
- Participants with poor lung function, as assessed by the investigator, that may impact study treatment, such as acute chronic obstructive pulmonary disease(COPD) or those requring long-term oral, intravenous corticosteroids (excluding inhalant/spray formulations).
- Uncontrolled immune diseases requring long-term systemic corticosteroid use (excluding topical use).
- Participants with reproductive system disorders that may cause abdominal pain (e.g., ovarian cysts, endometriosis, primary dysmenorrhea).
- Participants with significant laboratory abnormalities that, in the investigator's judgment, may affect safety or study completion, including:
- Hemoglobin <100g/L.
- Serum creatinine ≥1.5 times the upper limit of normal (ULN).
- Abnormal liver function (AST>1.5×ULN, ALT>1.5×ULN or total bilirubin >1.5×ULN).
- Clinically significant abnormalitieshe in routine stool tests or fecal occult blood indicating gastrointestinal lesions.
- Participants with active hepatitis (requiring or undergoing long-term treatment), HIV, or active tuberculosis.
- Participants with a history of drug or alcohol abuse (defined as consuming more than 14 standard drinks peer week: 1 standard drink= 360mL of beer, 45mL of 40% spirits, or 150mL of wine) or substance abuse.
- Participants with known allergies or intolerances to the investigational drug, similar drugs or excipients.
- Participants who have used anti-infective drugs (antibiotics, antifungals, antivirals) within 14 days prior to enrollment or require anti-infective treatment at the time of enrollment evaluation.
- Participants who have used drugs or foods that regulate intestinal microbiota (e.g., bifidobacterium, probiotics, prebiotics, fermented milk, yogurt) within 2 weeks prior to screening or during the study.
- Participants who have undergone hydrotherapy for bowel cleansing within one month prior to treatment.
- Women who are pregnant, breastfeeding, or unwilling to use effective contraception for 3 months after the last dose of the study drug.
- Participants who have participated in drug intervention clinical trials within 1 month prior to enrollment.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
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
Department of Microbiota Medicine & Medical Centre for Digestive Diseases,The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Faming Zhang, PhD, 086-025-58509883, fzhang@njmu.edu.cn
About this study
Official title: The Efficacy and Safety of CMTS4520 for Chronic Constipation in Adults： A Randomized, Double-Blind, Placebo-Controlled Trial.
This is a randomized controlled trial to explore the efficacy and safety of CMTS4520 (Dietary Fiber Probiotics) for patients with chronic constipation.
Read the detailed description
At least 100 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 CMTS4520 group (dietary fiber probiotics capsules) and the control group (placebo). 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
- Constipation
- Being tested
- CMTS4520 (dietary fiber probiotics), Placebo
- Keywords
- CMTS4520, constipation, randomized controlled trial, dietary fiber, probiotics
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMTS4520 (dietary fiber probiotics)Other
CMTS4520 is a synbiotic formulation containing a standardized ratio of plant-derived prebiotics and clinically validated probiotic strains. Participants will receive 2 weeks of CMTS4520 daily for chronic constipation.
PlaceboOther
Capsules with matching volume and consistent appearance to CMTS4520.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The patient will receive CMTS4520 (dietary fiber probiotics) capsules daily for 14 days. Receives: Other: CMTS4520 (dietary fiber probiotics) |
| Control | Placebo comparator | The patient will receive placebo of equal capsules daily for 14 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical response rate after treatment
A clinical response was defined as a patient achieving complete spontaneous bowel movement (CSBM) at least 50% of the time after receiving CMTS4520. CSBM was defined as the number of spontaneous defecation with complete exhaust feeling without taking remedial purgative or manual assistance.
Measured: One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration
Secondary outcomes (2)
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
The severity of AE was graded as mild (grade 1), moderate (grade 2), severe/disabling (grade 3), life threatening (grade 4), and death (grade 5). All AE were divided in definitely, probably and possibly related to treatment. The treatment-related AE we focused on included microbiota-related AEs (e.g., infection, diarrhea, abdominal pain, etc.) and route of delivery related AEs (e.g., nausea, vomiting, etc.).
Measured: Two-week post-CMTS4520 adminiatration, Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration
The weekly usage rate of assisted defecation drugs.
Percentage of days per week after CMTS4520 that assisted defecation drugs were used, which was compared to baseline.
Measured: One-week post-CMTS4520 administraion，Two-week post-CMTS4520 administraion, Four-week post-CMTS4520 administraion，Eight-week post-CMTS4520 administraion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start31 Mar 2025 (estimated)
- Primary completionJan 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
- Investigators
- Faming Zhang, PhD, Principal investigator, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832137
- Sponsor's protocol ID
- IIT-2024CMTS4520-001
- Status last verified
- Feb 2025
- First submitted
- 12 Feb 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lembo AJ, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Johnston JM. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology. 2010 Mar;138(3):886-95.e1. doi: 10.1053/j.gastro.2009.12.050. Epub 2010 Jan 4.
PubMed 20045700Schoenfeld P, Lacy BE, Chey WD, Lembo AJ, Kurtz CB, Reasner DS, Bochenek W, Tripp K, Currie MG, Fox SM, Blakesley RE, O'Dea CR, Omniewski ND, Hall ML. Low-Dose Linaclotide (72 mug) for Chronic Idiopathic Constipation: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial. Am J Gastroenterol. 2018 Jan;113(1):105-114. doi: 10.1038/ajg.2017.230. Epub 2017 Aug 22.
PubMed 29091082Khalif IL, Quigley EM, Konovitch EA, Maximova ID. Alterations in the colonic flora and intestinal permeability and evidence of immune activation in chronic constipation. Dig Liver Dis. 2005 Nov;37(11):838-49. doi: 10.1016/j.dld.2005.06.008. Epub 2005 Oct 5.
PubMed 16169298Korolkiewicz PK. Commentary on: "Does caffeine enhance bowel recovery after elective colorectal resection? A prospective double-blinded randomized clinical trial" Tech Coloproctol. 2021 Apr 26. doi: 10.1007/s10151-021-02450-7. Tech Coloproctol. 2021 Sep;25(9):1095-1096. doi: 10.1007/s10151-021-02489-6. Epub 2021 Jun 25. No abstract available.
PubMed 34170420Waitzberg DL, Logullo LC, Bittencourt AF, Torrinhas RS, Shiroma GM, Paulino NP, Teixeira-da-Silva ML. Effect of synbiotic in constipated adult women - a randomized, double-blind, placebo-controlled study of clinical response. Clin Nutr. 2013 Feb;32(1):27-33. doi: 10.1016/j.clnu.2012.08.010. Epub 2012 Aug 23.
PubMed 22959620Fosch SE, Ficoseco CA, Marchesi A, Cocucci S, Nader-Macias MEF, Perazzi BE. Contraception: Influence on Vaginal Microbiota and Identification of Vaginal Lactobacilli Using MALDI-TOF MS and 16S rDNA Sequencing. Open Microbiol J. 2018 Jun 29;12:218-229. doi: 10.2174/1874285801812010218. eCollection 2018.
PubMed 30069261Vazquez Roque M, Bouras EP. Epidemiology and management of chronic constipation in elderly patients. Clin Interv Aging. 2015 Jun 2;10:919-30. doi: 10.2147/CIA.S54304. eCollection 2015.
PubMed 26082622Gallegos-Orozco JF, Foxx-Orenstein AE, Sterler SM, Stoa JM. Chronic constipation in the elderly. Am J Gastroenterol. 2012 Jan;107(1):18-25; quiz 26. doi: 10.1038/ajg.2011.349. Epub 2011 Oct 11.
PubMed 21989145Fleming V, Wade WE. A review of laxative therapies for treatment of chronic constipation in older adults. Am J Geriatr Pharmacother. 2010 Dec;8(6):514-50. doi: 10.1016/S1543-5946(10)80003-0.
PubMed 21356503Zhao YF, Ma XQ, Wang R, Yan XY, Li ZS, Zou DW, He J. Epidemiology of functional constipation and comparison with constipation-predominant irritable bowel syndrome: the Systematic Investigation of Gastrointestinal Diseases in China (SILC). Aliment Pharmacol Ther. 2011 Oct;34(8):1020-9. doi: 10.1111/j.1365-2036.2011.04809.x. Epub 2011 Aug 17.
PubMed 21848795Chu H, Zhong L, Li H, Zhang X, Zhang J, Hou X. Epidemiology characteristics of constipation for general population, pediatric population, and elderly population in china. Gastroenterol Res Pract. 2014;2014:532734. doi: 10.1155/2014/532734. Epub 2014 Oct 16.
PubMed 25386187Long Y, Huang Z, Deng Y, Chu H, Zheng X, Yang J, Zhu Y, Fried M, Fox M, Dai N. Prevalence and risk factors for functional bowel disorders in South China: a population based study using the Rome III criteria. Neurogastroenterol Motil. 2017 Jan;29(1). doi: 10.1111/nmo.12897. Epub 2016 Jul 14.
PubMed 27412422Pare P, Ferrazzi S, Thompson WG, Irvine EJ, Rance L. An epidemiological survey of constipation in canada: definitions, rates, demographics, and predictors of health care seeking. Am J Gastroenterol. 2001 Nov;96(11):3130-7. doi: 10.1111/j.1572-0241.2001.05259.x.
PubMed 11721760
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of CMTS4520 for Chronic Constipation in Adults： A Randomized, Double-Blind, Placebo-Controlled Trial.
- ClinicalTrials.gov ID
- NCT06832137
- Acronym / sponsor ID
- IIT-2024CMTS4520-001
- Conditions
- Constipation
- Keywords
- CMTS4520, constipation, randomized controlled trial, dietary fiber, probiotics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 18 Feb 2025 (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 CMTS4520 (Dietary Fiber Probiotics) for patients with chronic constipation.
Detailed description
At least 100 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 CMTS4520 group (dietary fiber probiotics capsules) and the control group (placebo). 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: CMTS4520 (dietary fiber probiotics)The patient will receive CMTS4520 (dietary fiber probiotics) capsules daily for 14 days. |
| Control | Placebo comparator | Other: PlaceboThe patient will receive placebo of equal capsules daily for 14 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- -
- Voluntary sign informed consent, age 18-70 years old (including the threshold), male and female.
- For subjects diagnosed with chronic constipation, the duration of the disease is at least 6 months, and meet the following criteria:
- The subject or his/her legal representative has given informed consent, is fully aware of the purpose of the study, is able to communicate well with the investigator, and is able to understand and comply with the requirements of the study.
Key exclusion criteria (34 listed)
- -
- Participants with outlet obstruction constipation, such as rectal mucosal prolapse.
- Participants with a history of intestinal resection.
- Participants with intestinal stenosis caused by organic lesions of the digestive tract (e.g., tumor, inflammation, anal fissures, Crohn's disease, ulcerative colitis, radiation enteritis, intestinal adhesions, intestinal tuberculosis) as confirmed by colonoscopy within the past 24 months.
- Participants with constipation secondary to systemic diseases affecting the digestive tract, including:
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 |
|---|---|---|
| CMTS4520 (dietary fiber probiotics)CMTS4520 is a synbiotic formulation containing a standardized ratio of plant-derived prebiotics and clinically validated probiotic strains. Participants will receive 2 weeks of CMTS4520 daily for chronic constipation. | Other | Treatment |
| PlaceboCapsules with matching volume and consistent appearance to CMTS4520. | Other | Control |
Primary outcome
The clinical response rate after treatment
Time frame: One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration
A clinical response was defined as a patient achieving complete spontaneous bowel movement (CSBM) at least 50% of the time after receiving CMTS4520. CSBM was defined as the number of spontaneous defecation with complete exhaust feeling without taking remedial purgative or manual assistance.
2 secondary outcomes
The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0
Time frame: Two-week post-CMTS4520 adminiatration, Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration
The weekly usage rate of assisted defecation drugs.
Time frame: One-week post-CMTS4520 administraion，Two-week post-CMTS4520 administraion, Four-week post-CMTS4520 administraion，Eight-week post-CMTS4520 administraion
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 3 Apr 2025.
- Background: PubMed 20045700Lembo AJ, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Johnston JM. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology. 2010 Mar;138(3):886-95.e1. doi: 10.1053/j.gastro.2009.12.050. Epub 2010 Jan 4.
- Background: PubMed 29091082Schoenfeld P, Lacy BE, Chey WD, Lembo AJ, Kurtz CB, Reasner DS, Bochenek W, Tripp K, Currie MG, Fox SM, Blakesley RE, O'Dea CR, Omniewski ND, Hall ML. Low-Dose Linaclotide (72 mug) for Chronic Idiopathic Constipation: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial. Am J Gastroenterol. 2018 Jan;113(1):105-114. doi: 10.1038/ajg.2017.230. Epub 2017 Aug 22.
- Background: PubMed 16169298Khalif IL, Quigley EM, Konovitch EA, Maximova ID. Alterations in the colonic flora and intestinal permeability and evidence of immune activation in chronic constipation. Dig Liver Dis. 2005 Nov;37(11):838-49. doi: 10.1016/j.dld.2005.06.008. Epub 2005 Oct 5.
- Background: PubMed 34170420Korolkiewicz PK. Commentary on: "Does caffeine enhance bowel recovery after elective colorectal resection? A prospective double-blinded randomized clinical trial" Tech Coloproctol. 2021 Apr 26. doi: 10.1007/s10151-021-02450-7. Tech Coloproctol. 2021 Sep;25(9):1095-1096. doi: 10.1007/s10151-021-02489-6. Epub 2021 Jun 25. No abstract available.
- Background: PubMed 22959620Waitzberg DL, Logullo LC, Bittencourt AF, Torrinhas RS, Shiroma GM, Paulino NP, Teixeira-da-Silva ML. Effect of synbiotic in constipated adult women - a randomized, double-blind, placebo-controlled study of clinical response. Clin Nutr. 2013 Feb;32(1):27-33. doi: 10.1016/j.clnu.2012.08.010. Epub 2012 Aug 23.
- Background: PubMed 30069261Fosch SE, Ficoseco CA, Marchesi A, Cocucci S, Nader-Macias MEF, Perazzi BE. Contraception: Influence on Vaginal Microbiota and Identification of Vaginal Lactobacilli Using MALDI-TOF MS and 16S rDNA Sequencing. Open Microbiol J. 2018 Jun 29;12:218-229. doi: 10.2174/1874285801812010218. eCollection 2018.
- Background: PubMed 26082622Vazquez Roque M, Bouras EP. Epidemiology and management of chronic constipation in elderly patients. Clin Interv Aging. 2015 Jun 2;10:919-30. doi: 10.2147/CIA.S54304. eCollection 2015.
- Background: PubMed 21989145Gallegos-Orozco JF, Foxx-Orenstein AE, Sterler SM, Stoa JM. Chronic constipation in the elderly. Am J Gastroenterol. 2012 Jan;107(1):18-25; quiz 26. doi: 10.1038/ajg.2011.349. Epub 2011 Oct 11.
- Background: PubMed 21356503Fleming V, Wade WE. A review of laxative therapies for treatment of chronic constipation in older adults. Am J Geriatr Pharmacother. 2010 Dec;8(6):514-50. doi: 10.1016/S1543-5946(10)80003-0.
- Background: PubMed 21848795Zhao YF, Ma XQ, Wang R, Yan XY, Li ZS, Zou DW, He J. Epidemiology of functional constipation and comparison with constipation-predominant irritable bowel syndrome: the Systematic Investigation of Gastrointestinal Diseases in China (SILC). Aliment Pharmacol Ther. 2011 Oct;34(8):1020-9. doi: 10.1111/j.1365-2036.2011.04809.x. Epub 2011 Aug 17.
- Background: PubMed 25386187Chu H, Zhong L, Li H, Zhang X, Zhang J, Hou X. Epidemiology characteristics of constipation for general population, pediatric population, and elderly population in china. Gastroenterol Res Pract. 2014;2014:532734. doi: 10.1155/2014/532734. Epub 2014 Oct 16.
- Background: PubMed 27412422Long Y, Huang Z, Deng Y, Chu H, Zheng X, Yang J, Zhu Y, Fried M, Fox M, Dai N. Prevalence and risk factors for functional bowel disorders in South China: a population based study using the Rome III criteria. Neurogastroenterol Motil. 2017 Jan;29(1). doi: 10.1111/nmo.12897. Epub 2016 Jul 14.
- 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.
Faming Zhang, PhD principal investigator
The Second Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CMTS4520 (dietary fiber probiotics) in people with Constipation, 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 7 inclusion and 34 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: opening soon, as of the sponsor's last update on 3 Apr 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The clinical response rate after treatment (time frame: One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 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 NCT06832137, which also lists 13 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 3 Apr 2025.