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

NCT07061184 | Not Yet Recruiting Phase 4 DMC

• 2 other identifiers: I-25PJ14782022YFC2504006
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• IBS-SSS score

  The severity score questionnaire consists of 5 items and each item is rated on a scale of 0-100 points, leading to a total score of 0-500 points. An improvement of more than 50 points for IBS-SSS questionnaire is considered clinical effective.

  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).

Secondary Outcomes (2)

• IBS-QOL score

  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).

• self-reported symptoms including abdominal pain and diarrhea

  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).

Study Arms (2)

FLCWK

EXPERIMENTAL

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

Drug: FLCWK; Drug: Placebo

Placebo

PLACEBO COMPARATOR

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

Drug: FLCWK; Drug: Placebo

Interventions

FLCWK DRUG

FLCWK and matching placebo to be taken in a randomised order for 9 months

FLCWK; Placebo

Placebo DRUG

FLCWK and matching placebo to be taken in a randomised order for 9 months

FLCWK; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Current alcohol or drug abuse.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Central Study Contacts

Dong Wu, M.D.

CONTACT

8618612671010; dongwu@pumc.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of Gastroenterology

Model Details: N-of-1 trial

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)