ClinicalTrials.gg
Not yet recruitingNCT06437041Updated May 31, 2024

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

An interventional study of Ornidazole and Placebo in Irritable Bowel Syndrome, sponsored by Faming Zhang. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-31.

Sponsored by Faming Zhang · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Irritable Bowel Syndrome

Keywords

  • Irritable bowel syndrome
  • washed microbiota transplantation
  • antibiotic pretreatment
  • randomized controlled trial
  • transendoscopic enteral tube
03

In context

Irritable Bowel Syndrome

1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.

This study's planned enrollment of 96 is above the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Faming Zhang is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntarily signed the , age 18 years old or more, men and women all can;
  2. 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:

(1) 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.

  1. 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.

Exclusion criteria

Exclusion Criteria:

  • Subjects meeting any of the following exclusion criteria must be excluded from the study:

    1. The patient was accompanied by other mental disorders besides anxiety and depression.
    2. 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.).
    3. Has a history of major surgery within 3 months or a history of severetrauma, and recovery is not completely;
    1. There are 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.
    1. Any of the following abnormalities in cardiac function and performance:a. According to the (NYHA) cardiacfunction classification, cardiac function grade # or above;b. new onset myocardial infarction or unstable angina pectoriswithin 6 months;c. showed prolongation (QTc≥ 450ms in men and≥470ms in women);d. Drug- atrial arrhythmias and drug-refractory ventriculararrhythmias (including grade 2 or higher atrioventricular block).
    1. Patients with poor lung function that is considered by the investigatorto have an impact on the study treatment, such as patients with acuteexacerbation of or patients requiring long-term use of oral orintravenous for control (except inhalers/sprays); 9. No control 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 \< 100 g/L; B) Serum creatinine ≥1.5 times theupper limit of normal () C) abnormal liver function, defined asAST>1.5×ULN and/or >1.5×ULN and/or total >1.5×ULN;D) blood clotting function: acuities were 80 x 109 / L, > 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.
    1. Have active hepatitis (requiring or taking long-term treatment), , 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
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    Treatment

    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

  • Placebo comparator
    Control

    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

  • 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

  • DrugPlacebo

    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

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: One-week, Four-week and Eight-week post-WMT

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: One-week, Four-week and Eight-week post-WMT

07

Study locations

1 site
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06437041
Lead sponsor
Faming Zhang
Responsible party
Faming Zhang (Professor, Gastroenterology, The Second Hospital of Nanjing Medical University) — Sponsor-investigator
First posted
May 31, 2024
Start date
Jun 2024 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Completion
Mar 31, 2030 (estimated)
Last update
May 31, 2024

Study contacts

Faming Zhang, PhD
Contact
fzhang@njmu.edu.cn
086-025-58509883
Bota Cui
Contact
cuibota@njmu.edu.cn
086-025-58509884
Faming Zhang, PhD
principal investigator · The Second Hospital of Nanjing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ornidazole

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