CMTS4520 for Chronic Constipation in Adults

NCT06832137 | Not Yet Recruiting Phase 1

• 1 other identifier: IIT-2024CMTS4520-001
• 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 constipation.

Conditions

Constipation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

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

• The weekly usage rate of assisted defecation drugs.

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

Study Arms (2)

Treatment

EXPERIMENTAL

The patient will receive CMTS4520 (dietary fiber probiotics) capsules daily for 14 days.

Other: CMTS4520 (dietary fiber probiotics)

Control

PLACEBO COMPARATOR

The patient will receive placebo of equal capsules daily for 14 days.

Other: Placebo

Interventions

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.

Treatment

Placebo OTHER

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.
• 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.

You may not qualify if:

• 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:
• 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).

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 (13)

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  PMID: 29091082 BACKGROUND

• Khalif 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.

  PMID: 16169298 BACKGROUND

• Korolkiewicz 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.

  PMID: 34170420 BACKGROUND

• Waitzberg 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.

  PMID: 22959620 BACKGROUND

• Fosch 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.

  PMID: 30069261 BACKGROUND

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  PMID: 26082622 BACKGROUND

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  PMID: 21989145 BACKGROUND

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  PMID: 21356503 BACKGROUND

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  PMID: 11721760 BACKGROUND

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Study Officials

• Faming Zhang, PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Zhang, PhD

CONTACT

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

Bota Cui

CONTACT

086-025-58509884; cuibota@njmu.edu.cn

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 12, 2025
• First Posted: February 18, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: April 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)