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

ConditionIrritable Bowel Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFaming Zhang

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily signed the informed consent, age 18 years old or more, men and women all can;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: TreatmentExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Faming Zhang

Lead sponsor

The Second Hospital of Nanjing Medical University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: