Investigation of Acupoint in Irritable Bowel Syndrome Based on Biological Characteristics

NCT ID: NCT06365801

Last Updated: 2024-04-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-12-31

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.

Detailed Description

This study intends to include 50 healthy volunteers and 50 patients with IBS. The study objects are healthy volunteers and patients diagnosed with IBS from the Third Affiliated Hospital of Zhejiang Chinese Medicine University and social recruitment. This study is observational and does not involve randomized methods. At the same time, there is no blindness for subjects, indicators detection and input. The observation indexes were pain sensitivity, thermal radiation characteristics, microcirculation characteristics, biological ultra-weak luminescence, electrical characteristics, intestinal flora characteristics, tryptophan metabolites level and related scales at common acupoints of irritable bowel syndrome.

Conditions

Irritable Bowel Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Volunteers group

There are 50 healthy volunteers in the group.

No interventions assigned to this group

IBS group

There are 50 patients in the IBS group.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. 18 years old ≤ age ≤75 years old, gender is not limited;

2. No inflammatory bowel disease, lactose intolerance, intestinal bacterial overgrowth, parasitic infection, drug induced enteritis and other intestinal diseases;

3. No abdominal pain, frequency of defecation and changes in fecal characteristics in 1 week;

4. Provide healthy subjects with no obvious abnormalities reported by colonoscopy in the past 1 year;

5. 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;

6. No antidiarrheal drugs, antibiotics, gastrointestinal motility drugs or other related drugs affecting clinical studies within 4 weeks;

7. Clear consciousness, can complete normal communication;

8. Understands and is willing to comply with the research protocol and sign the informed consent.

1. 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;

2. 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;

3. 18 years old ≤ age ≤75 years old, gender is not limited;

4. No antidiarrheal drugs, antibiotics, gastrointestinal motility drugs or other related drugs that affect clinical studies have been taken within 4 weeks;

5. Clear consciousness, can complete normal communication;

6. Understands and is willing to comply with the research protocol and sign the informed consent.

Exclusion Criteria

1. 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;

2. Female volunteers who are pregnant or lactating, or in ovulation and menstruation period;

3. Volunteers with current abnormal body temperature;

4. Subjects currently participating in other clinical trials.

1. 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;

2. Pregnant or lactating women or female subjects in ovulation and menstruation period;

3. Patients with inflammatory bowel disease, lactose intolerance, intestinal bacterial overgrowth, parasitic infections, drug-induced enteritis and other intestinal diseases;

4. Patients with intestinal diseases such as functional constipation, functional diarrhea, opioid-induced constipation, and non-specific functional bowel disease;

5. Patients with functional gastrointestinal diseases such as functional dyspepsia, functional heartburn, central abdominal pain syndrome;

6. Patients with current abnormal body temperature;

7. Participants who are currently participating in other clinical trials.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xiaomei Shao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaomei Shao

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated hospital of Zhejiang Chinese Medical University

Central Contacts

Xiaomei Shao

Role: CONTACT

shaoxiaomei@zcmu.edu.cn

+8618957130287

Chuanlong Zhou

Role: CONTACT

471388079@qq.com

+8615868486255

Other Identifiers

2022YFC3500401-IBS

Identifier Type: -

Identifier Source: org_study_id