Mechanism of PERK - eIF2a Pathways in Intestinal Mucosal Barrier of IBS-D and the Role "Metabolism Ingredients" of Tongxieyaofang

Mechanism of PERK - eIF2a Pathways in Intestinal Mucosal Barrier of IBS-D and the Role "Metabolism Ingredients " of Tongxieyaofang

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.

Study Overview

• Status: Unknown
• Conditions: IBS (Irritable Bowel Syndrome)
• Intervention / Treatment: Drug: Tongxieyaofang(granule)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100091
      • Recruiting
      • Xiyuan Hospital
      • Contact: Fengyun Wang, Ph.D; Email: wfy811@163.com
      • Principal Investigator: Xia Li, B.S.Med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: health control group
Experimental: Tongxieyaofang granule group	Drug: Tongxieyaofang(granule); Take this granule twice a day,one bag for each time,one hour after a meal,for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irritable Bowel Syndrome Symptom Severity(IBS-SSS) scale	Patients are graded according to their own symptoms（abdominal pain，bloating，defecation satisfaction，the extent to which the disease affects the lives of patients，bowel movements）, the total score less than 75 points was considered as in remission, 75~175 as mild, 175~300 as moderate, and over 300 as severe. We will assess changes in patient scores before and after treatment to reflect the extent of disease remission.	IBS-SSS was evaluated by patients at 4th week
Bristol stool form scale（BSFS）	Different fecal types can reflect different intestinal transit times, the lower the score, the longer the transmission time; the higher the score, the shorter the transmission time. We will assess changes in scores before and after treatment to reflect the extent of disease remission.	BSFS was evaluated by patients at 4th week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS-D PRO( patient reported outcomes) Scale	Grading from the field of physiology, independence, and psychology，Use score changes to assess improvement in all areas of the patient.Minimum score is 0，means no symptoms，maximum score is 144，means all symptoms are severe.	IBS-D PRO Scale was evaluated at 4th week
SF-36(the MOS item short from health survey)Scale	Score evaluation from 8 aspects: physical function, role-physical, pain, global health status, vitality，social function,role-emotional， mental health.Use score changes to assess improvement in all areas of the patient. Maximum score is147.The higher the score, the better the status in all aspects.	SF-36 Scale was evaluated at 4th week

Collaborators and Investigators

• Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 10, 2019

Study Record Updates

• Last Update Posted (Actual): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 29, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: IBS-D
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: 81774304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No