Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT05088434
Eligibility Criteria:
Inclusion criteria:
* Patients of age between 18-and 65 years.
* Have IBS-Symptom Severity Scale (IBS-SSS) score \>175.
* All patients are required to have symptoms for at least 12 months, fulfilling the Rome III criteria with either diarrhoea-predominant irritable bowel syndrome (IBS-D) or mixed constipation and diarrhoea (IBS-M) with bloating or flatulence as predominant symptoms.
* All patients will undergo appropriate investigations to exclude organic disease.
Exclusion criteria:
* History of inflammatory bowel diseases, gastrointestinal malignancy, blood in stool
* Antibiotic use within 1 month prior to FMT
* Immunocompromised patient defined as taking immuno-suppressive medications
* History of opportunistic infections within 1 year prior to FMT, oral thrush, or disseminated lymphadenopathy.
* Patients who are scheduled for abdominal surgery.
* Pregnant or lactating women.
* Patients taking probiotics or taking antibiotics within 4 weeks prior to installation.
Inclusion criteria of donors for FMT:
* Close healthy, family members
* \> 18 years old.
Exclusion criteria of donors for FMT:
* Pregnancy or lactation
* History of inflammatory bowel diseases, IBS, chronic abdominal pain, or gastrointestinal malignancy, diarrhea, blood in stool
* Antibiotic and pre/probiotic use within 1 month prior to FMT.
* Immunocompromised defined as taking immuno-suppressive medications
* History of opportunistic infections within 1 year prior to FMT, oral thrush, or disseminated lymphadenopathy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05088434
Study Brief:
Protocol Section:
NCT05088434