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

Last updated: December 29, 2019
Sponsor: Xiyuan Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colic

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT04122586
81774304
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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

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 diseasesaffecting the digestive tract motion (e.g., hyperthyroidism,diabetes, chronic renalinsufficiency, and nervous system diseases);

  • undergoing or requiring constant use of drugs that may affect gastrointestinalfunctions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-HT3 receptorantagonist, 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 Design

Total Participants: 60
Study Start date:
August 01, 2018
Estimated Completion Date:
December 31, 2021

Connect with a study center

  • Xiyuan hospital

    Beijing, Beijing 100091
    China

    Active - Recruiting

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