Fecal Microbiota Transplantation for Irritable Bowel Syndrome
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangzhou First People's Hospital
About this trial
Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. FMT has a higher cure rate than standard antibiotic treatment for recurrent Clostridium difficile infections,and shows promising results in Inflammatory bowel disease（IBD）.However, few studies have evaluated whether FMT is effective to treat Irritable bowel syndrome(IBS).The investigators propose to determine the efficiency and safety of FMT in patients with Irritable bowel syndrome.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be able to give written informed consent.
Males and females aged >18 and <75
Have IBS as defined by the Rome IV criteria
Disqualifiers
pregnant or having a follow-up of less than 6 months;
unable to give informed consent;
suffering from other severe disease ,including liver and kidney failure, cancers, intestinal diseases, inflammatory bowel disease, C difficile infection;
unable to undergo endoscopy.
Trial design
Design model
Parallel
Treatments tested in this trial
fecal microbiota transplantation
Procedure/Surgery200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon
Infusion of sham
Procedure/SurgeryInfusion of sham
probiotics, antibiotics or antidepressants
DrugDrugs such as probiotics, antibiotics, antidepressants
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: fecal microbiota transplantationExperimental treatment 1 intervention
Group B: placebo fecal microbiota transplantationSham comparator 1 intervention
Group C: Traditional treatmentsSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Irritable Bowel Syndrome assessed by Symptom Severity Score (IBS-SSS)
This questionnaire was used for assessing IBS severity. Scores of five questions were calculated with the Visual Analogue Scale (VAS) scale: the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits and interference with quality of life. The scores ranged from 0 to 500, a higher score indicating worse condition :\<75 indicated remission; 75-175 indicated mild IBS;176-300 indicated moderate IBS; and \> 300 indicated severe IBS .
Time frame
baseline; one month;three months;six monthsSecondary outcomes
1
Change in Irritable Bowel Syndrome assessed by Quality of Life (IBS-QOL) Questionnaire Scores
The IBS-QOL questionnaire consisted of 34 items, covering eight aspects (dysphoria, interference with activity, body image, health worry, food avoidance,social reaction, sexual dysfunction, and relationships). Each item was rated on a 5-point Likert scale(1 = not at all, 5 = a great deal). Total scores were transformed to a 0±100 scale ranging from 0 (maximum quality of life) to 100 (poor quality of life).
Time frame
baseline; one month;three months;six months2
Change in Depression and Anxiety assessed by Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale(HAMA)
The Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) were used to evaluate the mental and psychological states of patients. HAMD scores were graded as follows: 8-19, mild depression; 20-34, moderate depression; ≥35, severely depression. HAMA scores were graded as follows: 14-20, mild anxiety; 21-28, moderate anxiety;≥29 , severe anxiety.
Time frame
baseline; one month;three months;six monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov