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New treatment option for Constipation
Official title Washed Microbiota Transplantation for Chronic Constipation in Adults
ClinicalTrials.gov ID: NCT06106685
What this study is testing
What is High-dose washed microbiota suspension?
High-dose washed microbiota suspension is an investigational medicine, being studied as a potential treatment for constipation.
Also referred to as WMT-001.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, randomized, double-blind, placebo-controlled, dose-exploring clinical study to explore the safety and efficacy of washed microbiota transplantation (WMT) for patients with chronic constipation.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- \- Meet all of the following
- Voluntary sign informed consent, age 18-70 years old (including the threshold), male and female.
- For people diagnosed with chronic constipation, the duration of the disease is at least 6 months, and the following conditions are met:
- Frequency of spontaneous defecation \<3 times/week (spontaneous defecation refers to spontaneous defecation without the aid of remedial purgatives or...
- Dry and hard stool: More than a quarter of the stool is type 1 or 2 on the Bristol Fecal Trait Scale.
You likely can't join if
- \- All exclusion criteria below are not met:
- Outlet obstruction constipation, such as rectal mucosal prolapse.
- History of abdominal and pelvic surgery, except for no intestinal complications after cholecystectomy, caesarean section, appendectomy, and treatment...
- Combined with the colonoscopy results in the past 24 months, patients with intestinal stenosis caused by organic lesions of the digestive tract (such...
- Other systemic diseases involving the digestive tract (such as neurological diseases (such as Parkinson's disease, spinal cord injury, multiple...
- Have a history of major surgery or severe trauma within 3 months and have not fully recovered.
See the full eligibility criteria
Who can join
- \- Meet all of the following
- Voluntary sign informed consent, age 18-70 years old (including the threshold), male and female.
- For people diagnosed with chronic constipation, the duration of the disease is at least 6 months, and the following conditions are met:
- 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...
What rules you out
- \- All exclusion criteria below are not met:
- Outlet obstruction constipation, such as rectal mucosal prolapse.
- History of abdominal and pelvic surgery, except for no intestinal complications after cholecystectomy, caesarean section, appendectomy, and treatment of intestinal polyps.
- Combined with the colonoscopy results in the past 24 months, patients with intestinal stenosis caused by organic lesions of the digestive tract (such as tumor, inflammation, anal fissure, Crohn's disease, intestinal...
- Other systemic diseases involving the digestive tract (such as neurological diseases (such as Parkinson's disease, spinal cord injury, multiple sclerosis, etc.), muscle diseases (such as amyloidosis, dermatomyositis...
- Have a history of major surgery or severe trauma within 3 months and have not fully recovered.
- There are contraindications for endoscopic intestinal catheterization via colonic approach, such as severe intestinal stenosis, obstruction, deep ulcer, and high risk of perforation. There are serious ulcers or a large...
- Cardiac function and cardiac performance have any of the following abnormalities:
- According to the New York Heart Association (NYHA) heart function rating, the heart function rating is grade III and above.
- people with new myocardial infarction or unstable angina pectoris within 6 months.
- Electrocardiogram indicated prolonged corrected QT interval (QTc) (male QTc≥450ms, female QTc≥470ms).
- Atrial arrhythmias that cannot be stably controlled by drugs and ventricular arrhythmias that require drug control (including grade 2 and above atrioventricular block).
- Poor lung function that the investigator assessed as having an impact on study treatment, such as in people with acute chronic obstructive pulmonary disease or long-term oral, intravenous hormone control (other than...
- Uncontrolled immune disease and/or the need for long-term use of hormones (except for topical use).
- people with poorly controlled metabolic disease (e.g., thyroid dysfunction) or metabolic disease with gastrointestinal complications (e.g., gastrointestinal autonomic dysfunction, diabetic gastroparesis, etc.);
- Patients with reproductive system diseases (including but not limited to ovarian cysts, endometriosis, primary dysmenorrhea, etc.) that are prone to abdominal pain.
- Significant abnormalities in laboratory tests that, in the investigator's judgment, may affect subject safety or completion of the clinical study include:
- Hemoglobin \<100g/L.
- Serum creatinine ≥1.5 times the upper limit of normal (ULN)
- Abnormal liver function, defined as Glutamic oxalacetic transaminase \>1.5×ULN and/or Glutamic-pyruvic transaminase\>1.5×ULN and/or total bilirubin \>1.5×ULN.
- Coagulation function: PLT≤80×109/L, activated partial thromboplastin time \> 1.5×ULN, prothrombin time \> 1.5×ULN, International Normalized Ratio \> 1.5×ULN.
- The results of routine stool or fecal occult blood are abnormal and have clinical significance to indicate gastrointestinal disease.
- people with active hepatitis who require or are on long-term use of therapeutic drugs, HIV, or active tuberculosis.
- people with a history of drug or alcohol abuse (i.e., consuming more than 14 servings (1 serving is 360mL) of beer, 45mL of 40% spirits, or 150mL of wine per week) or substance abuse.
- Known allergy to the investigational drug, similar drugs or excipients.
- Anti-infective drugs (antibiotics, antifungal, antiviral) were used within 14 days prior to enrollment, or anti-infective therapy was required at the time of enrollment evaluation.
- Drugs and supplements that affect gastrointestinal motility and function that cannot be discontinued in trials, including but not limited to: antibiotics, such as erythromycin; Drugs that regulate intestinal...
- Those who use hydrotherapy for defecation/bowel cleansing within one month prior to treatment.
- Women who are pregnant or breastfeeding, or who refuse to use effective contraception within 3 months after the last dose of medication.
- Participants who had participated in clinical trials of drug intervention within 3 months before drug administration.
- Patients with malignant tumors.
- There are other situations in which the investigator deems it inappropriate to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.