AzTrials
AzTrials

DiarrhoeaPhase 1/2NCT06839586

CMTS4520 for Chronic Diarrhoea in Adults

A Phase 1/2 study testing CMTS4520 (dietary fiber and probiotics) in people with Diarrhoea, run by The Second Hospital of Nanjing Medical University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This is a randomized controlled trial to explore the efficacy and safety of CMTS4520 (Dietary Fiber Probiotics) for patients with chronic diarrhoea. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diarrhoea
What is being tested?
CMTS4520 (dietary fiber and 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
20 Feb 2025to 1 Jul 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.
  • Using the Rome IV criteria as the diagnostic criteria:
  • Defecation frequency is greater than or equal to 3 times per day or significantly exceeds the usual habit, with a disease duration of > 4 weeks, or recurrent diarrhea with an intermittent period within 2 - 4 weeks;
  • Loose stools: Types 5, 6, and 7 based on the Bristol Stool Form 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 a history of intestinal resection.
  • Participants with 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 diarrhoea secondary to systemic diseases affecting the digestive tract, including:
  • Neurological diseases (e.g., Parkinson's disease, spinal cord injury, multiple sclerosis).
  • Muscle diseases (e.g., amyloidosis, dermatomyositis).
Show all 32Show fewer
  • Psychiatric disorders or severe mood disorders (e.g., A Hospital Anxiety and Depression Scale score ≥15).
  • Opioid-induced diarrhoea.
  • Poorly controlled metabolic diseases (e.g., thyroid dysfunction) or metabolic diseases with gastrointestinal complications (e.g., gastrointestinal autonomic dysfunction, diabetic gastroparesis).
  • Diarrhea secondary to intestinal infectious diseases, including but not limited to Clostridioides difficile infection, chronic bacillary dysentery, intestinal tuberculosis, and parasitic infection-induced diarrhea.
  • 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 gut microbiota (e.g., bifidobacterium, probiotics, prebiotics, fermented milk, yogurt) within 2 weeks prior to screening or during the study.
  • 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.

China1 site

  • Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

Other trials in China

About this study

Official title: The Efficacy and Safety of CMTS4520 for Chronic Diarrhoea 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 diarrhoea.

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
Diarrhoea
Being tested
CMTS4520 (dietary fiber and probiotics), Placebo
Keywords
CMTS4520, diarrhoea, randomized controlled trial, dietary fiber, probiotics
Medical subject headings
Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMTS4520 (dietary fiber and probiotics)Drug

    CMTS4520 is a synbiotic formulation containing a standardized ratio of plant-derived prebiotics and clinically validated probiotic strains. Participants will receive 4 weeks of CMTS4520 daily for chronic diarrhoea.

  • PlaceboDrug

    Capsules with matching volume and consistent appearance to CMTS4520.

Study groups in NCT06839586
Study groupRoleWhat they receive
TreatmentExperimentalThe patient will receive CMTS4520 (dietary fiber probiotics) capsules daily for 4 weeks.
Receives: Drug: CMTS4520 (dietary fiber and probiotics)
ControlPlacebo comparatorThe patient will receive placebo of equal capsules daily for 4 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The clinical response rate after treatment

    A clinical response was described as the change of the defecation frequency and the fecal consistency scores (assessed using the Bristol Stool Form Scale) after receiving CMTS4520.

    on the first day (D1) and the fourth week (D28) post-treatment compared to baseline, as well as the average weekly fecal consistency scores.

    Measured: One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration

Secondary outcomes (6)

  1. 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: Immediately post-CMTS4520 administration, One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration

  2. The abdominal discomfort after treatment

    The scales include Gastrointestinal Symptom Rating Scale (GSRS) for abdominal discomfort.

    Measured: One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration

  3. The abdominal discomfort after treatment

    The scales include IBS Symptom Severity Scale (IBS-SSS) for abdominal discomfort.

    Measured: One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration

  4. The abdominal discomfort after treatment

    The scales include IBS Global Improvement Scale (IBS-GIS) for abdominal discomfort.

    Measured: One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration

  5. The quality of life after treatment

    IBS Quality of Life Scale (IBS-QOL) to measure quality of life.

    Measured: One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration

  6. The psychological states after treatment

    Hospital Anxiety and Depression Scale (HADS) to measure psychological states.

    Measured: One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start20 Feb 2025
  3. Primary completion31 Jan 2030 (estimated)
  4. Study completion1 Jul 2030 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06839586
Sponsor's protocol ID
IIT-2024CMTS4520-003
Status last verified
Feb 2025
First submitted
14 Feb 2025
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhou Q, Verne ML, Fields JZ, Lefante JJ, Basra S, Salameh H, Verne GN. Randomised placebo-controlled trial of dietary glutamine supplements for postinfectious irritable bowel syndrome. Gut. 2019 Jun;68(6):996-1002. doi: 10.1136/gutjnl-2017-315136. Epub 2018 Aug 14.

    PubMed 30108163

  • Skrzydlo-Radomanska B, Prozorow-Krol B, Cichoz-Lach H, Majsiak E, Bierla JB, Kanarek E, Sowinska A, Cukrowska B. The Effectiveness and Safety of Multi-Strain Probiotic Preparation in Patients with Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Controlled Study. Nutrients. 2021 Feb 26;13(3):756. doi: 10.3390/nu13030756.

    PubMed 33652763

  • Weiss GA, Hennet T. Mechanisms and consequences of intestinal dysbiosis. Cell Mol Life Sci. 2017 Aug;74(16):2959-2977. doi: 10.1007/s00018-017-2509-x. Epub 2017 Mar 28.

    PubMed 28352996

  • Mari A, Abu Baker F, Mahamid M, Sbeit W, Khoury T. The Evolving Role of Gut Microbiota in the Management of Irritable Bowel Syndrome: An Overview of the Current Knowledge. J Clin Med. 2020 Mar 4;9(3):685. doi: 10.3390/jcm9030685.

    PubMed 32143424

  • Bhattarai Y, Muniz Pedrogo DA, Kashyap PC. Irritable bowel syndrome: a gut microbiota-related disorder? Am J Physiol Gastrointest Liver Physiol. 2017 Jan 1;312(1):G52-G62. doi: 10.1152/ajpgi.00338.2016. Epub 2016 Nov 23.

    PubMed 27881403

  • Lembo AJ, Lacy BE, Zuckerman MJ, Schey R, Dove LS, Andrae DA, Davenport JM, McIntyre G, Lopez R, Turner L, Covington PS. Eluxadoline for Irritable Bowel Syndrome with Diarrhea. N Engl J Med. 2016 Jan 21;374(3):242-53. doi: 10.1056/NEJMoa1505180.

    PubMed 26789872

  • Pimentel M, Lembo A, Chey WD, Zakko S, Ringel Y, Yu J, Mareya SM, Shaw AL, Bortey E, Forbes WP; TARGET Study Group. Rifaximin therapy for patients with irritable bowel syndrome without constipation. N Engl J Med. 2011 Jan 6;364(1):22-32. doi: 10.1056/NEJMoa1004409.

    PubMed 21208106

  • Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ, Gangarosa LM, Thiny MT, Stizenberg K, Morgan DR, Ringel Y, Kim HP, DiBonaventura MD, Carroll CF, Allen JK, Cook SF, Sandler RS, Kappelman MD, Shaheen NJ. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012 Nov;143(5):1179-1187.e3. doi: 10.1053/j.gastro.2012.08.002. Epub 2012 Aug 8.

    PubMed 22885331

  • Camilleri M. Peripheral mechanisms in irritable bowel syndrome. N Engl J Med. 2013 Feb 7;368(6):578-9. doi: 10.1056/NEJMc1214185. No abstract available.

    PubMed 23388017

  • Enck P, Aziz Q, Barbara G, Farmer AD, Fukudo S, Mayer EA, Niesler B, Quigley EM, Rajilic-Stojanovic M, Schemann M, Schwille-Kiuntke J, Simren M, Zipfel S, Spiller RC. Irritable bowel syndrome. Nat Rev Dis Primers. 2016 Mar 24;2:16014. doi: 10.1038/nrdp.2016.14.

    PubMed 27159638

  • Farthing M, Salam MA, Lindberg G, Dite P, Khalif I, Salazar-Lindo E, Ramakrishna BS, Goh KL, Thomson A, Khan AG, Krabshuis J, LeMair A; WGO. Acute diarrhea in adults and children: a global perspective. J Clin Gastroenterol. 2013 Jan;47(1):12-20. doi: 10.1097/MCG.0b013e31826df662. No abstract available.

    PubMed 23222211

  • 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.

    PubMed 38582094

  • 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.

    PubMed 34115764

  • 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.

    PubMed 30243583

  • 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.

    PubMed 39708822

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CMTS4520 (dietary fiber and probiotics) in people with Diarrhoea, 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 6 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 18 Nov 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 NCT06839586, which also lists 17 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 18 Nov 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in