Washing and transplanting gut bacteria to treat chronic constipation

Washed Microbiota Transplantation for Chronic Constipation in Adults: a Single-center, Randomized, Double-blind, Placebo-controlled, Dose-exploring Clinical Study

This study is testing if washing and transplanting gut bacteria can help adults with chronic constipation feel better.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The Second Hospital of Nanjing Medical University (other)
• Locations: 2 sites (Nanjing, Jiangsu and 1 other locations)
• Trial ID: NCT06106685 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and effectiveness of washed microbiota transplantation (WMT) in adults suffering from chronic constipation. Participants aged 18-70 will be randomly assigned to receive either a high-dose or low-dose of washed microbiota suspension, or a placebo. The study will collect data on demographic characteristics, intestinal symptoms, and clinical outcomes over a series of visits, including a double-blind evaluation for safety and efficacy. Follow-up assessments will occur at 32 and 60 days post-treatment to monitor long-term effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 diagnosed with chronic constipation for at least 6 months, experiencing infrequent and hard stools.

Not a fit: Patients with outlet obstruction constipation or other specific gastrointestinal conditions may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option for patients suffering from chronic constipation.

How similar studies have performed: While the concept of microbiota transplantation is gaining traction, this specific approach is relatively novel and has not been extensively tested in the context of chronic constipation.

Eligibility criteria

Inclusion Criteria:

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Meet all of the following inclusion criteria :

1. Voluntary sign informed consent, age 18-70 years old (including the threshold), male and female.
2. For subjects diagnosed with chronic constipation, the duration of the disease is at least 6 months, and the following conditions are met:

   1. Frequency of spontaneous defecation \<3 times/week (spontaneous defecation refers to spontaneous defecation without the aid of remedial purgatives or manual assistance).
   2. Dry and hard stool: More than a quarter of the stool is type 1 or 2 on the Bristol Fecal Trait 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:

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All exclusion criteria below are not met:

1. Outlet obstruction constipation, such as rectal mucosal prolapse.
2. History of abdominal and pelvic surgery, except for no intestinal complications after cholecystectomy, caesarean section, appendectomy, and treatment of intestinal polyps.
3. 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.
4. 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.
5. Have a history of major surgery or severe trauma within 3 months and have not fully recovered.
6. 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.
7. Cardiac function and cardiac performance have any of the following abnormalities:

   1. According to the New York Heart Association (NYHA) heart function rating, the heart function rating is grade III and above.
   2. Subjects with new myocardial infarction or unstable angina pectoris within 6 months.
   3. Electrocardiogram indicated prolonged corrected QT interval (QTc) (male QTc≥450ms, female QTc≥470ms).
   4. Atrial arrhythmias that cannot be stably controlled by drugs and ventricular arrhythmias that require drug control (including grade 2 and above atrioventricular block).
8. 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).
9. Uncontrolled immune disease and/or the need for long-term use of hormones (except for topical use).
10. Subjects with poorly controlled metabolic disease (e.g., thyroid dysfunction) or metabolic disease with gastrointestinal complications (e.g., gastrointestinal autonomic dysfunction, diabetic gastroparesis, etc.);
11. Patients with reproductive system diseases (including but not limited to ovarian cysts, endometriosis, primary dysmenorrhea, etc.) that are prone to abdominal pain.
12. Significant abnormalities in laboratory tests that, in the investigator's judgment, may affect subject safety or completion of the clinical study include:

    1. Hemoglobin \<100g/L.
    2. Serum creatinine ≥1.5 times the upper limit of normal (ULN)
    3. 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.
    4. Coagulation function: PLT≤80×109/L, activated partial thromboplastin time \> 1.5×ULN, prothrombin time \> 1.5×ULN, International Normalized Ratio \> 1.5×ULN.
    5. The results of routine stool or fecal occult blood are abnormal and have clinical significance to indicate gastrointestinal disease.
13. Subjects with active hepatitis who require or are on long-term use of therapeutic drugs, HIV, or active tuberculosis.
14. 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.
15. Known allergy to the investigational drug, similar drugs or excipients.
16. 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.
17. 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 microecology, such as probiotics such as Bifidobacterium; Parasympathetic inhibitors, such as scopolamine, atropine, belladonna, etc. Muscle relaxants such as succinylcholine; Antidiarrheal agents such as loperamide, Smecta, etc. Opioid preparations; Inhibition of gastric acid secretion drugs.
18. Those who use hydrotherapy for defecation/bowel cleansing within one month prior to treatment.
19. Women who are pregnant or breastfeeding, or who refuse to use effective contraception within 3 months after the last dose of medication.
20. Participants who had participated in clinical trials of drug intervention within 3 months before drug administration.
21. Patients with malignant tumors.
22. There are other situations in which the investigator deems it inappropriate to participate in this study.

Where this trial is running

Nanjing, Jiangsu and 1 other locations

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

Study contacts

• Principal investigator: Faming Zhang — The Second Hospital of Nanjing Medical University
• Study coordinator: Faming Zhang, PhD

Conditions: Constipation, washed microbiota transplantation, constipation, difficult defecation