irritable bowel syndrome
Conditions
Interventions
Donors group:NA
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: For patients: 1) Patients who fulfilled the Rome IV criteria for the diagnosis of IBS, aged 18-70 years; 2) Patients who have experienced failure of at least 3 conventional therapies for IBS; 3) Absence of red flags such as weight loss, hematochezia; For donors of fecal microbiota: 1) Aged 18-30 years; 2) Live in Shanghai in the next 2 years; 3) Previously and currently healthy with a normal BMI; 4) A regular life with appropriate exercise, balanced and diverse diet and healthy psychology; 5) A regular bowel habit with stool consistency at type 3 or 4 based on Bristol Stool Form Scale.
Exclusion criteria
Exclusion criteria: For patients: 1) Pregnant, planning pregnancy or lactating; 2) Psychiatric disorder or unable to cooperate with treatment and follow-up visit; 3) Immunodeficiency or treatment with immune-modulating medication; 4) Use of probiotics within the previous 3 months or treatment with antibiotics within 1 month prior to study entry; 5) Having undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy; 6) Presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease; 7) Presence of severe diseases related to heart, brain, kidney and lung or concomitant malignancies; 8) Presence of other conditions that researchers consider inappropriate to participate in this study. For donors of fecal microbiota: Absolute contraindications: 1) Known or high risk of infectious diseases such as HIV, HAV, HBV, HCV, syphilis, Creutzfeldt-Jakob disease or travel history to epidemic area in the past 3 months; 2) Participation in high-risk sexual behaviours; 3) Drug abuse; 4) A history of needle injuries or scratches and bites from cats and dogs in the past six months 5) Tattoo or body piercing during the past six months in informal institutions; 6) Received live attenuated vaccine in the past six months; 7) Received blood products in the past year; 8) A history of recent infection including Upper respiratory tract infection and infectious diarrhea; 9) A history of gastrointestinal diseases such as IBD, IBS, gastrointestinal tumors and polyps or recurrent gastrointestinal symptoms such as regurgitation, belching, abdominal pain, abdominal distension, diarrhea, chronic constipation; 10) Have used antibiotics, probiotics, PPI, immunomodulating drug or antitumor drugs in the past three months; 11) Smoking or alcoholic abuse; 12) A history of malignancies, metabolic diseases, autoimmune diseases, allergic diseases, psychiatric disorders or chronic pain (fibromyalgia, chronic fatigue syndrome, etc) II. Relative contraindications: 1) A history of gastrointestinal surgery; 2) =3 colds per year at average; 3) Family history of gastrointestinal malignancies, metabolic diseases or autoimmune diseases 4) Keeping pets; 5) Roommates had a history of acute gastrointestinal infection in the past six months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline IBS symptom severity scale (IBS-SSS) score at 9 weeks;Response rate at 9 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline Gastrointestinal Symptom Rating Scale (GSRS) score at 1 week, 1 month, 9 weeks and 6 months;Change from baseline IBS symptom severity scale (IBS-SSS) score at 1 week, 1 month and 6 months;Change from baseline IBS-Quality of Life (IBS-QoL) score at 1 month, 3 months and 6 months;Change from baseline Self-rating Anxiety Scale (SAS) score at 1 month, 3 months and 6 months;Change from baseline Self-rating Depression Scale (SDS) score at 1 month, 3 months and 6 months;Response rate at 1 week, 1month, 3 months and 6 months;Change from baseline fecal microbiota composition at 1 week, 1 month and 6 months;Change from baseline fecal metabolites at 1 week, 1 month and 6 months; | — |
Countries
China
Contacts
Public ContactLing Dong
Zhongshan Hospital, Fudan University
Outcome results
None listed