Clinical trial NCT06365801: Investigation of Acupoint in Irritable Bowel Syndrome Based on Biological Characteristics
Official title: Investigation of Acupoint in Irritable Bowel Syndrome Based on Biological Characteristics: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Irritable Bowel Syndrome
Keywords: irritable bowel syndrome
acupoint
biological characteristics
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for healthy volunteers:

  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.
* Inclusion criteria for IBS patients:

  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:

* Exclusion criteria for healthy volunteers:

  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.
* Exclusion criteria for patients with IBS:

  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.

Primary outcomes:
measure: Pain sensitivity
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
measure: Thermal radiation characteristics
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
measure: Microcirculation characteristics
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
measure: Electrical characteristics
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
measure: Biological ultra-weak luminescence
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
Secondary outcomes:
measure: Intestinal flora
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
measure: Tryptophan metabolites
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
measure: Bristol Fecal Traits Grading Scale
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
measure: Severity of IBS (IBS-SSS)
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
measure: IBS Quality of Life (IBS-QOL )
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
measure: TCM Constitution Survey
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
measure: Gastrointestinal Symptoms Rating Scale (GSRS)
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
measure: Self-Rating Anxiety Scale (SAS)
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
measure: Self-Rating Depression Scale (SDS)
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: the baseline and 4 times during the follow-up period (1st month, 2nd month, 4th month and 6th month after enrollment)
Other outcomes:
Locations:
Study officials:
affiliation: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Xiaomei Shao
role: PRINCIPAL_INVESTIGATOR
References: