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Could a daily fiber supplement soothe chronic diarrhoea?

NCT ID NCT06839586

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a daily supplement called CMTS4520, which combines dietary fiber and probiotics, can help adults with chronic diarrhoea. One hundred participants will receive either the supplement or a placebo for four weeks. Researchers will track changes in stool frequency and consistency to see if the treatment works and is safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CMTS4520 (a mix of dietary fiber and probiotics)
What this could lead to
If it works, this could offer a simple, non-drug option to manage chronic diarrhoea and improve daily comfort.
What could go wrong
This is an early-phase trial with only 100 participants, so results may not apply to everyone. The effect may be small or no better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Meet all of the following inclusion criteria : 1. Voluntary sign informed consent, age 18-70 years old (including the threshold), male and female. 2. Using the Rome IV criteria as the diagnostic criteria: 1. 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; 2. Loose stools: Types 5, 6, and 7 based on the Bristol Stool Form Scale. 3. 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. Exclusion Criteria: All exclusion criteria below are not met: 1. Participants with a history of intestinal resection. 2. 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. 3. Participants with diarrhoea secondary to systemic diseases affecting the digestive tract, including: 1. Neurological diseases (e.g., Parkinson's disease, spinal cord injury, multiple sclerosis). 2. Muscle diseases (e.g., amyloidosis, dermatomyositis). 3. Psychiatric disorders or severe mood disorders (e.g., A Hospital Anxiety and Depression Scale score ≥15). 4. Opioid-induced diarrhoea. 5. Poorly controlled metabolic diseases (e.g., thyroid dysfunction) or metabolic diseases with gastrointestinal complications (e.g., gastrointestinal autonomic dysfunction, diabetic gastroparesis). 4. Diarrhea secondary to intestinal infectious diseases, including but not limited to Clostridioides difficile infection, chronic bacillary dysentery, intestinal tuberculosis, and parasitic infection-induced diarrhea. 5. Have a history of major surgery or severe trauma within 3 months and have not fully recovered. 6. Participants with any of the following cardiac abnormalities: 1. New York Heart Association (NYHA) Class III or higher heart failure. 2. Myocardial infarction or unstable angina within the past 6 months. 3. Prolonged QTc interval on electrocardiogram (≥450ms for males, ≥470ms for females). 4. Atrial arrhythmias that cannot be stably controlled by drugs and ventricular arrhythmias requiring pharmacological control (including grade 2 or higher atrioventricular block). 7. 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). 8. Uncontrolled immune diseases requring long-term systemic corticosteroid use (excluding topical use). 9. Participants with reproductive system disorders that may cause abdominal pain (e.g., ovarian cysts, endometriosis, primary dysmenorrhea). 10. Participants with significant laboratory abnormalities that, in the investigator's judgment, may affect safety or study completion, including: 1. Hemoglobin \<100g/L. 2. Serum creatinine ≥1.5 times the upper limit of normal (ULN). 3. Abnormal liver function (AST\>1.5×ULN, ALT\>1.5×ULN or total bilirubin \>1.5×ULN). 4. Clinically significant abnormalitieshe in routine stool tests or fecal occult blood indicating gastrointestinal lesions. 11. Participants with active hepatitis (requiring or undergoing long-term treatment), HIV, or active tuberculosis. 12. 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. 13. Participants with known allergies or intolerances to the investigational drug, similar drugs or excipients. 14. 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. 15. 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. 16. Women who are pregnant, breastfeeding, or unwilling to use effective contraception for 3 months after the last dose of the study drug. 17. Participants who have participated in drug intervention clinical trials within 1 month prior to enrollment. 18. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Nanjing, Jiangsu, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.