Fengliao Changweikang for Diarrhea-predominant Irritable Bowel Syndrome: N-of-1 Trial
China50 participantsStarted 2025-11
Plain-language summary
Irritable bowel syndrome with diarrhea (IBS-D) is a functional gastrointestinal disorder, with characteristics of defecation related abdominal pain and diarrhea. Routine treatment strategy for IBS-D is symptom-based with unsatisfactory results, while there is a growing interest in complementary and alternative medicine such as Traditional Chinese Medicine. However, lack of high-quality evidences being the obstacle for its development.
This study aims to evaluate the efficacy of Fengliao Changweikang Keli (FLCWK) on symptoms and health-related quality of life in mild to moderate IBS-D patients.
After 2-week run-in period, each participant will be randomized to a sequence of six 4-week double-blind treatment periods of FLCWK 8 g three times daily or placebo, separated by 2-week washout periods.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged between 18 and 75 years.
✓. Mild to moderate IBS-D patients, with IBS Severity Scoring System (IBS-SSS) scores of 75 to 300 points\[14\].
✓. Ability to complete questionnaires and provide written informed consent.
✓. Current use of IBS medications (probiotics, antibiotics, antispasmodic, antidiarrheal and neuromodulators) should be prescribed on a stable dose at least 30 days prior to enrollment, and have no plan to change the dose, diet or lifestyle.
✓. Normal blood cell count, liver function, creatinine and urea levels within the last 2 weeks.
Exclusion criteria
✕. History of organic gastrointestinal diseases such as inflammatory bowel disease, celiac disease and malignancy.
✕. Scores of IBS-SSS \> 300 points or IBS-SSS \< 75 points.
✕. History of severe heart, kidney or liver diseases.
✕. Pregnant or breastfeeding.
What they're measuring
1
IBS-SSS score
Timeframe: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).