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NCT Number: NCT07061184

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location contact

Dong Wu, M.D.

CONTACT

[email protected]

8618612671010

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Current alcohol or drug abuse.

Treatment and study plan

FLCWK

Drug

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

Placebo

Drug

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

Primary outcomes

  1. IBS-SSS score

    Time frame: 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).

    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.

Secondary outcomes

  1. IBS-QOL score

    Time frame: 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).

    IBS-QOL is a 34-item questionnaire assessing patient's health related quality of life, and higher scores indicate a better quality of life. IBS-QOL focuses on eight domains, namely dysphoria, activity interference, body image, health worry, food avoidance, social reaction, sexual and relationships, and an increase of more than 14 points indicates clinical improvement in quality of life. The minimal clinically important difference (MCID) on the IBS-QOL is defined as a change of 10 points in the total score.

  2. self-reported symptoms including abdominal pain and diarrhea

    Time frame: 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).

    The score of worst abdominal pain in the past 24 hours will be evaluated by visual analogue scale (VAS) ranging from 0 to 10. The stool consistency of the past 24 hours will also be rated by BSFS, based on a 1 to 7 scale where 1 corresponds to a hard stool and 7 corresponds to watery diarrhea.

Study contacts

Contact information is provided by the study sponsor or research team.

Dong Wu, M.D.

CONTACT

[email protected]

8618612671010

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

The Efficacy of Fengliao Changweikang Keli for Patients With Diarrhea-predominant Irritable Bowel Syndrome: Study Protocol for a Multicenter, Randomized, Placebo-controlled N-of-1 Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 11, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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