Fengliao Changweikang for Diarrhea-predominant Irritable Bowel Syndrome: N-of-1 Trial

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Not yet enrolling; Phase 4

Conditions: Traditional Chinese Medicine (TCM); Irritable Bowel Syndrome - Diarrhoea; N of 1 Study Design; Efficacy and Safety

Treatments: Drug: Placebo; Drug: FLCWK

Study type: Interventional

Funder types: Other

Identifiers

NCT07061184

I-25PJ1478

2022YFC2504006 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged between 18 and 75 years.
2. Mild to moderate IBS-D patients, with IBS Severity Scoring System (IBS-SSS) scores of 75 to 300 points[14].
3. Ability to complete questionnaires and provide written informed consent.
4. 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.
5. Normal blood cell count, liver function, creatinine and urea levels within the last 2 weeks.

Exclusion criteria

1. History of organic gastrointestinal diseases such as inflammatory bowel disease, celiac disease and malignancy.
2. Scores of IBS-SSS > 300 points or IBS-SSS < 75 points.
3. History of severe heart, kidney or liver diseases.
4. Pregnant or breastfeeding.
5. Current alcohol or drug abuse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

FLCWK

Experimental group

Description:

FLCWK one sachet (8 g) to be taken three times daily in 1 month treatment peroid, 3 treatment periods in 9 months

Treatment:

Drug: FLCWK

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Placebo one sachet (8 g) to be taken three times daily in 1 month treatment peroid, 3 treatment periods in 9 months

Treatment:

Drug: FLCWK

Drug: Placebo