Washed Microbiota Transplantation for Chronic Constipation in Adults

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Constipation

In brief

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.

Key facts

Study ID

NCT06106685

Run by

The Second Hospital of Nanjing Medical University

People needed

18

Starts

2023-07-24

Expected to finish

2026-12-01

Last updated by the study team

2023-10-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet all of the following inclusion criteria :
• 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 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 requirements of the study.

You may not qualify 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 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 adhesion, ulcerative colitis, intestinal tuberculosis, etc.) and constipation.
• 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, etc.), mental disorders (such as depression, etc.), metabolic endocrine disorders (such as diabetes, hypothyroidism, etc.), or constipation caused by opioids.
• 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 number of false polyps in the fixation area, which is not suitable for fixation. The subject's behavior is seriously out of control.
• 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.
• Subjects 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 subjects with acute chronic obstructive pulmonary disease or long-term oral, intravenous hormone control (other than inhalant/spray hormone use).
• Uncontrolled immune disease and/or the need for long-term use of hormones (except for topical use).
• Subjects 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.
• Subjects with active hepatitis who require or are on long-term use of therapeutic drugs, HIV, or active tuberculosis.
• Subjects 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.

Where it is running

• The second affiliated hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
• the Second Affiliated of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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