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Irritable Bowel SyndromeNCT06437041

Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Irritable Bowel Syndrome

A study testing Ornidazole in people with Irritable Bowel Syndrome, run by Faming Zhang at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a randomized controlled trial to explore the efficacy of antibiotic pretreatment on the efficacy of WMT in the treatment of Irritable bowel syndrome in adults: a multi-center, randomized, placebo-controlled clinical study Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Irritable Bowel Syndrome
What is being tested?
Ornidazole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteChina
Study dates
Jun 2024to 31 Mar 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily signed the informed consent, age 18 years old or more, men and women all can;
  • According to the Roman IV standard diagnosis of IBS: recurrent abdominal pain or discomfort, weekly attacks within the past 3 months at least 3 d, accompanied by the following two and two or more:
  • associated with defecation; (2) changes in defecation frequency; (3) changes in stool characteristics (appearance).
  • The following symptoms were not included in the diagnostic criteria but supported the diagnosis: (1) abnormal bowel frequency: bowel movements less than 3 times per week or more than 3 times per day; (2) the excrement characters and abnormal: dry bulb dung or hard dung, or paste dung/dilute waste water; (3) bowel effort; (4) Defecation urgency, endless defecation, mucus excretion and abdominal distension.
  • Diagnostic considerations: (1) Diagnosis should be based on the exclusion of organic diseases; (2) the intestinal symptoms of irritable bowel syndrome has certain characteristics, such as abdominal pain or discomfort with bowel movements, this group of symptoms is different from the other functional bowel disease, such as functional constipation, functional diarrhea, functional abdominal pain). (3) Irritable bowel syndrome often coexists with other functional gastrointestinal disorders.
  • 3. 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.

Who cannot join

  • Subjects meeting any of the following exclusion criteria must be excluded from the study:
  • The patient was accompanied by other mental disorders besides anxiety and depression.
  • Combined with the results of colonoscopy within the past 24 months, the patient has an organic lesion of the digestive tract (e.g., tumor, inflammation, anal fissure, Crohn's disease, ulcerative colitis, intestinal adhesion, intestinal tuberculosis, etc.).
  • Has a history of major surgery within 3 months or a history of severetrauma, and recovery is not completely;
  • 6. There are contraindications to colonic transendoscopic intestinal tubeimplantation, such as severe intestinal stenosis, obstruction, deep ulcer,and high risk of operation perforation; Severe ulcers or a large numberof pseudopolyps exist in the fixed area of titanium clips, which are notsuitable for fixation. The subjects' behavior was seriously uncontrolled.
  • 7. Any of the following abnormalities in cardiac function and performance:a. According to the New York Heart Association (NYHA) cardiacfunction classification, cardiac function grade # or above;b. new onset myocardial infarction or unstable angina pectoriswithin 6 months;c. ECG showed QTc prolongation (QTc≥ 450ms in men and≥470ms in women);d. Drug-refractory atrial arrhythmias and drug-refractory ventriculararrhythmias (including grade 2 or higher atrioventricular block).
  • 8. Patients with poor lung function that is considered by the investigatorto have an impact on the study treatment, such as patients with acuteexacerbation of COPD or patients requiring long-term use of oral orintravenous steroids for control (except inhalers/sprays); 9. No control autoimmune disease and/or need long-term use of hormone(except local external use sex); 10. 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.) 11. Suffering from reproductive system diseases (including but not limited toovarian cysts, endometriosis, primary dysmenorrhea, etc.) that may lead to abdominal pain; 12. Significant laboratory abnormalities that, in the judgment of theinvestigator, may affect the safety of the subjects or the completion ofthe clinical study, including:A) the hemoglobin < 100 g/L; B) Serum creatinine ≥1.5 times theupper limit of normal (ULN) C) abnormal liver function, defined asAST>1.5×ULN and/or ALT>1.5×ULN and/or total bilirubin >1.5×ULN;D) blood clotting function: PLT acuities were 80 x 109 / L, APTT > 1.5 xULN, PT > 1.5 x ULN, INR > 1.5 x ULN; E) abnormal results or defecateoccult blood stool and has prompted the clinical significance of thegastrointestinal tract.
  • 13. Have active hepatitis (requiring or taking long-term treatment), HIV, oractive tuberculosis; 14. A history of drug or alcohol abuse (i.e., drinking more than 14 servings per week of beer, 45 mL of 40% spirits, or 150 mL of wine) or substance abuse; 15. The known allergic to research similar drugs, drugs or accessories; 16. Use of anti-infective drugs (antibiotics, antifungal, antiviral) within 14days before enrollment, or need anti-infective treatment at enrollmentevaluation; 17. Drugs and supplements that affect gastrointestinal motility and functioncannot be stopped during the study, including but not limited to:antibiotics such as erythromycin; Drugs that modulate the intestinal microecology, such as probiotics such as Bifidobacterium; Theparasympathetic nerve inhibitors, some scopolamine and atropine,belladonna, etc; Muscle relaxants, such as succinylcholine; Opioid preparations; Drugs thatinhibit gastric acid secretion; 18. Pregnant or lactating women, or refusing to use an effectivecontraceptive method within 3 months after the last dose of treatment; 19. 3 months prior to dosing involved in drug interventional clinical trials; 20. Suffering from malignant tumors;21. There were other circumstances that the investigator consideredinappropriate for participatin

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

Other trials in China

About this study

Official title: Effect of Antibiotic Pretreatment on the Efficacy of WMT in the Treatment of Irritable Bowel Syndrome in Adults: a Multi-center, Randomized, Placebo-controlledClinical Study

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

Read the detailed description

All included in the standard but do not accord with standard of any rule out subjects will be included in this study. Demographic characteristics, Gastrointestinal Symptoms Rating Scales(GSRS),IBS Symptom Severity Scaleand(IBS-SSS) 、Pittsburgh Sleep Quality Index(PSQI)、Self-rating Anxiety Scale(SAS)、Self-rating Depression Scale(SDS)and clinical outcomes will be collected. After the treatment, the efficacy and safety will be evaluated during the follow-up period.

Being tested
Ornidazole, Placebo
Keywords
Irritable bowel syndrome, washed microbiota transplantation, antibiotic pretreatment, randomized controlled trial, transendoscopic enteral tube
Medical subject headings
Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrnidazoleDrug

    Also called washed microbiota transplantation

    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.

  • PlaceboDrug

    Also called washed microbiota transplantation

    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

Study groups in NCT06437041
Study groupRoleWhat they receive
TreatmentExperimentalPatients 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.
Receives: Drug: Ornidazole
ControlPlacebo comparatorPatients 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gastrointestinal Symptoms Rating Scales(GSRS)

    Gastrointestinal Symptom Rating Scale (GSRS) included 5 items: abdominal pain (3 items), reflux (2 items), dyspepsia (4 items), diarrhea (3 items) and constipation (3 items). The severity of each symptom was assessed using a 4-point Likert scale, with a score of 0 indicating no symptoms and a score of 3 indicating very severe symptoms.

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

  2. IBS Symptom Severity Scaleand(IBS-SSS)

    IBS symptom severity scale (IBS-SSS) consists of five items, which assess the severity of abdominal pain, the frequency of abdominal pain, the degree of abdominal distention and discomfort, the satisfaction of bowel habit and behavior, and the impact of intestinal symptoms on life. Each item was divided into 5 levels, increasing by 20 points, and the total score was 500 points. A score of 75 to 175 is mild, 176 to 300 is moderate, and more than 300 is severe.

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

Secondary outcomes (3)
  1. Pittsburgh Sleep Quality Index(PSQI)

    PSQI was used to assess the sleep quality of the subjects in the last month. It consisted of 19 self-rated items and 5 patient-rated items.

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

  2. Self-rating Anxiety Scale(SAS)

    Self-rating anxiety Scale (SAS) is a self-rating scale used to evaluate the subjective feelings of patients with anxiety. It contains 20 items and is divided into 4 grades.

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

  3. Self-rating Depression Scale(SDS)

    Self-rating Depression Scale,SDS is a self-rating scale that measures subjective feelings of depression. It contains 20 items and is scored on a 4-point scale.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2024
  2. Study startJun 2024 (estimated)
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
96 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06437041
Sponsor's protocol ID
WMT-ABx-IBS-202405
Status last verified
May 2024
First submitted
24 May 2024
Last updated
31 May 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35014601
  • 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.

    PubMed 38500062
  • 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.

    PubMed 28000680

Questions about this trial

What is this clinical trial studying?

A study testing Ornidazole in people with Irritable Bowel Syndrome, run by Faming Zhang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Faming Zhang, PhD (086-025-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastrointestinal Symptoms Rating Scales(GSRS) (time frame: One-week, Four-week and Eight-week post-WMT). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06437041, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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