Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Chronic Constipation

NCT06427863 | Not Yet Recruiting

• 1 other identifier: WMT-Anti-CC-202405
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial to explore the efficacy of antibiotic pretreatment on the efficacy of WMT in the treatment of chronic constipation in adults: a multi-center, randomized, placebo-controlled clinical study

Conditions

Chronic Constipation

Keywords

chronic constipation; washed microbiota transplantation; antibiotic pretreatment; randomized controlled trial; transendoscopic enteral tube

Outcome Measures

Primary Outcomes (3)

• Response rate of complete spontaneous bowel movements（CSBM）

  Overall CSBM respondents defined in the study of drug treatment in patients with the number of weeks of at least 50% of the time meet the CSBM weeks response week (4/8). Response was defined as a CSBM of at least three times in the week and an increase of at least one CSBM from baseline. CSBM was defined as the number of voluntary bowel movements with complete defecation sensation without taking remedial laxatives or manual assistance.

  One-week, Four-week and Eight-week post-WMT

• The extent of change observed in Constipation assessment scale (CAS) of participants

  The CAS consisted of 8 items, including abdominal distension, changes in exhaust volume, decreased frequency of defecation, watery stool, rectal obstruction or pressure, rectal pain during defecation, thinness of stool, and unsuccessful defecation. Each item was scored from 0 to 2 according to the severity of symptoms. Each item score was summed, with 0 as no constipation and 16 as the most severe constipation.

  One-week, Four-week and Eight-week post-WMT

• The extent of change observed in Patient-Assessment of Constipation Quality Of Life（PAC-QOL）of participants

  The Constipation Quality of Life Scale (PAC-QOL) contains 28 items, including physical discomfort, anxiety, psychosocial discomfort, and satisfaction. It reflects the impact of constipation on daily life in the past two weeks.

  One-week, Four-week and Eight-week post-WMT

Secondary Outcomes (2)

• The extent of change observed in stool properties of participants

  One-week post-WMT

• Rate of Adverse Events

  One-week, Four-week and Eight-week post-WMT

Study Arms (2)

Treatment

EXPERIMENTAL

Patients will receive three enemas of ornidazole 0.5g+50ml saline through the TET tube, followed by WMT once daily for a duration of 3 days.

Drug: Ornidazole

Control

PLACEBO COMPARATOR

Patients will receive three enemas of a placebo of equal volume through the TET tube, followed by WMT once daily for a duration of 3 days.

Drug: Placebo

Interventions

Ornidazole DRUG

Patients will receive three consecutive enemas of ornidazole 0.5g+50ml saline through the TET tube, followed by WMT treatment once daily for a duration of 3 days

Also known as: washed microbiota transplantation

Treatment

Placebo DRUG

Patients will receive three consecutive enemas of placebo of equal volume through the TET tube, followed by WMT treatment once daily for a duration of 3 days

Also known as: washed microbiota transplantation

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female, aged ≥18 years old, provided written informed consent;
• Subjects diagnosed with chronic constipation, with a duration of at least 6 months, and with the following conditions:
• \) spontaneous bowel movement frequency \<3 times/week (spontaneous bowel movement was defined as spontaneous bowel movement without rescue laxatives or manual assistance); 2) waste hard: at least 25% of defecation in Bristol stool traits scale type 1 or 2.
• \. The subjects or their legal representatives gave informed consent, fully understood the purpose of the study, were able to communicate well with the researchers, and understood and complied with the requirements of the study.

You may not qualify if:

• Presence of outlet obstruction and constipation, such as rectal mucosal prolapse
• Combined with the results of colonoscopy in the past 24 months, those with intestinal stenosis caused by organic lesions of the digestive tract (such as tumor, inflammation, anal fissure, Crohn's disease, ulcerative colitis, intestinal adhesion, intestinal tuberculosis, etc.) and constipation;
• Constipation caused by other systemic diseases involving the digestive tract, such as nervous system 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 and endocrine disorders (such as diabetes, hypothyroidism, etc.) or opioids, etc.
• Has a history of abdominal pelvic surgery, but after cystic resection, cesarean section, does not appear after appendectomy postoperative intestinal complications, and intestinal polyps except after treatment;
• Has a history of major surgery within 3 months or a history of severe trauma, and recovery is not completely;
• There are contraindications to colonic transendoscopic intestinal tube implantation, such as severe intestinal stenosis, obstruction, deep ulcer, and high risk of operation perforation; Severe ulcers or a large number of pseudopolyps exist in the fixed area of titanium clips, which are not suitable for fixation. The subjects' behavior was seriously uncontrolled.
• Any of the following abnormalities in cardiac function and performance:
• According to the New York Heart Association (NYHA) cardiac function classification, cardiac function grade Ⅲ or above;
• new onset myocardial infarction or unstable angina pectoris within 6 months;
• ECG showed QTc prolongation (QTc≥ 450ms in men and ≥470ms in women);
• Drug-refractory atrial arrhythmias and drug-refractory ventricular arrhythmias (including grade 2 or higher atrioventricular block).
• Patients with poor lung function that is considered by the investigator to have an impact on the study treatment, such as patients with acute exacerbation of COPD or patients requiring long-term use of oral or intravenous steroids for control (except inhalers/sprays);
• No control autoimmune disease and/or need long-term use of hormone (except local external use sex);
• Patients with metabolic diseases and poorly controlled by drugs (such as thyroid dysfunction), or patients with metabolic diseases accompanied by gastrointestinal function complications (such as gastrointestinal autonomic nerve dysfunction, diabetic gastroparesis, etc.);
• Suffering from reproductive system diseases (including but not limited to ovarian cysts, endometriosis, primary dysmenorrhea, etc.) that may lead to abdominal pain;

Sponsors & Collaborators

• Faming Zhang: lead

Study Sites (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

Related Publications (5)

• Keshteli AH, Millan B, Madsen KL. Pretreatment with antibiotics may enhance the efficacy of fecal microbiota transplantation in ulcerative colitis: a meta-analysis. Mucosal Immunol. 2017 Mar;10(2):565-566. doi: 10.1038/mi.2016.123. Epub 2016 Dec 21. No abstract available.

  PMID: 28000680 BACKGROUND

• Singh P, Alm EJ, Kelley JM, Cheng V, Smith M, Kassam Z, Nee J, Iturrino J, Lembo A. Effect of antibiotic pretreatment on bacterial engraftment after Fecal Microbiota Transplant (FMT) in IBS-D. Gut Microbes. 2022 Jan-Dec;14(1):2020067. doi: 10.1080/19490976.2021.2020067.

  PMID: 35014601 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

• Bazzocchi G, Giovannini T, Giussani C, Brigidi P, Turroni S. Effect of a new synbiotic supplement on symptoms, stool consistency, intestinal transit time and gut microbiota in patients with severe functional constipation: a pilot randomized double-blind, controlled trial. Tech Coloproctol. 2014 Oct;18(10):945-53. doi: 10.1007/s10151-014-1201-5. Epub 2014 Aug 5.

  PMID: 25091346 BACKGROUND

• Xu J, Xu H, Guo X, Zhao H, Wang J, Li J, He J, Huang H, Huang C, Zhao C, Li Y, Zhou Y, Peng Y, Nie Y. Pretreatment with an antibiotics cocktail enhances the protective effect of probiotics by regulating SCFA metabolism and Th1/Th2/Th17 cell immune responses. BMC Microbiol. 2024 Mar 18;24(1):91. doi: 10.1186/s12866-024-03251-2.

  PMID: 38500062 BACKGROUND

MeSH Terms

Interventions

Ornidazole

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

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: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)