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

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ClinicalTrials.gov Identifier: NCT04122586
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Xiyuan Hospital of China Academy of Chinese Medical Sciences

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.

Condition or disease Intervention/treatment Phase
IBS (Irritable Bowel Syndrome) Drug: Tongxieyaofang(granule) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Mechanism of PERK - eIF2a Pathways in Intestinal Mucosal Barrier of IBS-D and the Role "Metabolism Ingredients " of Tongxieyaofang
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

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




Primary Outcome Measures :
  1. Irritable Bowel Syndrome Symptom Severity(IBS-SSS) scale [ Time Frame: IBS-SSS was evaluated by patients at 4th week ]
    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.

  2. Bristol stool form scale(BSFS) [ Time Frame: BSFS was evaluated by patients at 4th week ]
    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.


Secondary Outcome Measures :
  1. IBS-D PRO Scale [ Time Frame: IBS-D PRO Scale was evaluated at 4th week ]
    Grading from the field of physiology, independence, and psychology,Use score changes to assess improvement in all areas of the patient.

  2. SF-36 Scale [ Time Frame: SF-36 Scale was evaluated at 4th week ]
    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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122586


Contacts
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Contact: fengyun Wang, Ph.D +8601062835641 wfy811@163.com

Locations
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China, Beijing
Xiyuan hospital Recruiting
Beijing, Beijing, China, 100091
Contact: Fengyun Wang, Ph.D       wfy811@163.com   
Principal Investigator: Xia Li, B.S.Med         
Sponsors and Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences

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Responsible Party: Xiyuan Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT04122586     History of Changes
Other Study ID Numbers: 81774304
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiyuan Hospital of China Academy of Chinese Medical Sciences:
IBS-D
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases