Investigation of Acupoint in Irritable Bowel Syndrome Based on Biological Characteristics

NCT06365801 | Not Yet Recruiting DMC

• 1 other identifier: 2022YFC3500401-IBS
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Irritable bowel syndrome (IBS) is a common functional disorder of the digestive system characterized by recurrent abdominal pain associated with bowel movements or changes in bowel habits. Although there are reviews and guidelines for treating IBS, the complexity and diversity of IBS manifestations make treatment difficult. By detecting and exploring the biological characteristics presented by the relevant meridian point reaction, this project clarified the specificity and regularity of the connection between the acupoint and the Zangfu reflected by this phenomenon, and conducted correlation analysis based on the intestinal flora, tryptophan metabolite levels and related scales of patients with IBS.

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome; acupoint; biological characteristics

Outcome Measures

Primary Outcomes (5)

• Pain sensitivity

  Select the measurement point, place the probe of the handheld pain threshold testing instrument vertically on the pain measurement point, slowly and steadily press, and stop the pressure when the subject feels pain (or the subject can stop the pressure). At this point, the reading on the monitor is the subject's pain threshold. After the measurement is completed, press the zero button to measure the next point or the next subject.

  the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)

• Thermal radiation characteristics

  The NEC R550 infrared thermal imager and the InfRec Analyzer NS9500 computer software were used to store and save the infrared thermal images taken, and the temperature data were analyzed, the temperature values of relevant acupoints in corresponding coordinates were extracted, and the average temperature values of acupoints in the 6 infrared thermal images were calculated as their basic temperatures.

  the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)

• Microcirculation characteristics

  The PeriCam PSI laser speckle imager was adopted to store and record the speckle imaging images and curves with the support of PIM Soft computer software, and the blood flow data was analyzed, the blood flow values of the corresponding acupoints were extracted, and the average perfusion volume of the acupoints within 2 minutes was calculated as the perfusion volume index.

  the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)

• Electrical characteristics

  Meridian point resistance meter was used to measure the point resistance, each point was detected for 5 minutes, the data was stored and analyzed by excel2019, the relative resistance value of the corresponding point was extracted, and the average resistance value of the point was calculated within 5 minutes.

  the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)

• Biological ultra-weak luminescence

  It is divided into the UPE detection system of photomultiplier tube (PMT) and the UPE image acquisition system of charge coupled device (CCD).PMT: The data of each measurement point is the self-luminous intensity of the subject per second.CCD: The image acquisition software Andor Solis is used to store the captured CCD image, analyze the ultra-weak luminescence data of the acquisition site, and extract the average value of the ultra-weak luminescence of the corresponding position as its basic value.

  the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)

Secondary Outcomes (10)

• Intestinal flora

  the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)

• Tryptophan metabolites

  the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)

• Bristol Fecal Traits Grading Scale

  the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)

• Severity of IBS (IBS-SSS)

  the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)

• IBS Quality of Life (IBS-QOL )

  the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)

Study Arms (2)

Healthy Volunteers group

There are 50 healthy volunteers in the group.

IBS group

There are 50 patients in the IBS group.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study targets IBS patients and healthy volunteers, among whom IBS patients are required to meet the Rome IV standard for IBS and the Expert Consensus on the Diagnosis and Treatment of IBS in Chinese Medicine (2017).

You may qualify if:

• years old ≤ age ≤75 years old, gender is not limited;
• No inflammatory bowel disease, lactose intolerance, intestinal bacterial overgrowth, parasitic infection, drug induced enteritis and other intestinal diseases;
• No abdominal pain, frequency of defecation and changes in fecal characteristics in 1 week;
• Provide healthy subjects with no obvious abnormalities reported by colonoscopy in the past 1 year;
• Healthy subjects who can provide medical examination reports within the past 1 year and have routine physical examination conducted by researchers to confirm that there are no heart and lung diseases, digestive, urinary, blood, endocrine, nervous system and other serious underlying diseases;
• No antidiarrheal drugs, antibiotics, gastrointestinal motility drugs or other related drugs affecting clinical studies within 4 weeks;
• Clear consciousness, can complete normal communication;
• Understands and is willing to comply with the research protocol and sign the informed consent.
• Patients who can provide colonoscopy report in the past 1 year and meet the Rome IV standard of irritable bowel syndrome and TCM syndrome differentiation type;
• Provide medical examination reports within the past 1 year to confirm patients without digestive, circulatory, respiratory, urinary, reproductive, endocrine, nervous system and other malignant tumors and serious underlying diseases;
• years old ≤ age ≤75 years old, gender is not limited;
• No antidiarrheal drugs, antibiotics, gastrointestinal motility drugs or other related drugs that affect clinical studies have been taken within 4 weeks;
• Clear consciousness, can complete normal communication;
• Understands and is willing to comply with the research protocol and sign the informed consent.

You may not qualify if:

• Those who have mental illness, alcohol dependence or a history of drug abuse and cognitive impairment are unable to cooperate with the examination and understanding of the subject;
• Female volunteers who are pregnant or lactating, or in ovulation and menstruation period;
• Volunteers with current abnormal body temperature;
• Subjects currently participating in other clinical trials.
• Those who have mental illness, alcohol dependence or a history of drug abuse and cognitive impairment are unable to cooperate with the examination and understanding of the subject;
• Pregnant or lactating women or female subjects in ovulation and menstruation period;
• Patients with inflammatory bowel disease, lactose intolerance, intestinal bacterial overgrowth, parasitic infections, drug-induced enteritis and other intestinal diseases;
• Patients with intestinal diseases such as functional constipation, functional diarrhea, opioid-induced constipation, and non-specific functional bowel disease;
• Patients with functional gastrointestinal diseases such as functional dyspepsia, functional heartburn, central abdominal pain syndrome;
• Patients with current abnormal body temperature;
• Participants who are currently participating in other clinical trials.

Sponsors & Collaborators

• The Third Affiliated hospital of Zhejiang Chinese Medical University: lead

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples and blood samples

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Xiaomei Shao

  The Third Affiliated hospital of Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomei Shao

CONTACT

+8618957130287; shaoxiaomei@zcmu.edu.cn

Chuanlong Zhou

CONTACT

+8615868486255; 471388079@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 15, 2024
• Study Start: April 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share