Clinical trial NCT04122586: Mechanism of PERK - eIF2a Pathways in Intestinal Mucosal Barrier of IBS-D and the Role "Metabolism Ingredients" of Tongxieyaofang
Official title: Mechanism of PERK - eIF2a Pathways in Intestinal Mucosal Barrier of IBS-D and the Role "Metabolism Ingredients " of Tongxieyaofang
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IBS (Irritable Bowel Syndrome)
Keywords: IBS-D
Lead sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Diarrhea irritable bowel syndrome(IBS-D）has seriously affected health and quality of life of patients.It may be important pathogenesis in development and recurrence of the process of IBS-D,excessive endoplasmic reticulum stress (ERS) activated PERK(proteinkinaseR-like ERkinase，PERK)-eIF2a(eukaryotic translation initiation factor 2 alpha,eIF2a) pathway and damaged intestinal mucosal epithelial Barrier. Tongxieyaofang(TXYF) had obtained satisfactory effect in treating IBS-D in clinic and previous study, but it is unknown that herbal formula how to work.This project applies metabolomics method to detect plasma,urine and stool metabolites for patients before and after treatment, to determine the effects of the"multiple ingredients"of TXYF in body.


Eligibility criteria: Inclusion Criteria:

* Patients meeting the diagnostic criteria of Western medicine for IBS-D;
* aged 18-70 years old; with a baseline IBS-SSS score over 75 points;
* voluntarily signed the informed consent;
* local resident who could ensure follow-ups, with basic reading ability

Exclusion Criteria:

* Patients with IBS-C, -M, and uncertain forms;
* accompanied with serious lesions in major organs including heart, liver, and kidney, hematopoietic system diseases, and tumors;
* gastrointestinal organic disease (e.g., chronic pancreatitis), or systemic diseases affecting the digestive tract motion (e.g., hyperthyroidism,diabetes, chronic renal insufficiency, and nervous system diseases);
* undergoing or requiring constant use of drugs that may affect gastrointestinal functions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonist, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, and intestinal flora regulating drugs);
* with history of abdominal surgery (e.g., cholecystectomy);
* with an allergy history of tested drugs or severe allergy history of food;
* pregnant and lactating female;
* with a history of neurological or psychiatric disorders;
* or participating in other clinical trial.

Primary outcomes:
measure: Irritable Bowel Syndrome Symptom Severity(IBS-SSS) scale
timeFrame: IBS-SSS was evaluated by patients at 4th week
measure: Bristol stool form scale（BSFS）
timeFrame: BSFS was evaluated by patients at 4th week
Secondary outcomes:
measure: IBS-D PRO( patient reported outcomes) Scale
timeFrame: IBS-D PRO Scale was evaluated at 4th week
measure: SF-36(the MOS item short from health survey)Scale
timeFrame: SF-36 Scale was evaluated at 4th week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xiyuan hospital
state: Beijing
Study officials:
References: