CMTS4520 for Chronic Diarrhoea in Adults

NCT06839586 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: IIT-2024CMTS4520-003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diarrhoea

Keywords

CMTS4520; diarrhoea; randomized controlled trial; dietary fiber; probiotics

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

• The incidence of treatment-related adverse events (AE) assessed by CTCAE, Version 5.0

  Immediately post-CMTS4520 administration, One-week post-CMTS4520 administration，Two-week post-CMTS4520 administration，Four-week post-CMTS4520 administration，Eight-week post-CMTS4520 administration

• The abdominal discomfort after treatment

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

• The abdominal discomfort after treatment

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

• The abdominal discomfort after treatment

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

• The quality of life after treatment

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

Study Arms (2)

Treatment

EXPERIMENTAL

The patient will receive CMTS4520 (dietary fiber probiotics) capsules daily for 4 weeks.

Drug: CMTS4520 (dietary fiber and probiotics)

Control

PLACEBO COMPARATOR

The patient will receive placebo of equal capsules daily for 4 weeks.

Drug: Placebo

Interventions

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.

Treatment

Placebo DRUG

Capsules with matching volume and consistent appearance to CMTS4520.

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, China

Location

Related Publications (17)

• 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.

  PMID: 30108163 BACKGROUND

• 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.

  PMID: 33652763 BACKGROUND

• 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.

  PMID: 28352996 BACKGROUND

• 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.

  PMID: 32143424 BACKGROUND

• 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.

  PMID: 27881403 BACKGROUND

• 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.

  PMID: 26789872 BACKGROUND

• 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.

  PMID: 21208106 BACKGROUND

• 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.

  PMID: 22885331 BACKGROUND

• 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.

  PMID: 23388017 BACKGROUND

• 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.

  PMID: 27159638 BACKGROUND

• 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.

  PMID: 23222211 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Arasaradnam RP, Brown S, Forbes A, Fox MR, Hungin P, Kelman L, Major G, O'Connor M, Sanders DS, Sinha R, Smith SC, Thomas P, Walters JRF. Guidelines for the investigation of chronic diarrhoea in adults: British Society of Gastroenterology, 3rd edition. Gut. 2018 Aug;67(8):1380-1399. doi: 10.1136/gutjnl-2017-315909. Epub 2018 Apr 13.

  PMID: 29653941 BACKGROUND

MeSH Terms

Conditions

Diarrhea

Interventions

Dietary Fiber; Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Supplements

Study Officials

• Faming Zhang, PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 21, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: November 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)