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Investigation of intestinal bacterial overgrowth in patients with functional gastrointestinal diseases

Investigation of intestinal bacterial overgrowth in patients with functional gastrointestinal diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400087223
Enrollment
Unknown
Registered
2024-07-23
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

functional gastrointestinal diseases

Interventions

Patients with functional gastrointestinal diseases:N/A

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of Rome IV FGIDs and contain symptoms of bloating or abdominal discomfort: The diagnostic criteria for Rome IV FD are: a. Postprandial discomfort syndrome: must include one or two of the following, at least 3 days per week: 1) Postprandial fullness and discomfort (which interferes with daily activities); 2) Early satiety discomfort (so that you can't complete the usual amount of food). b. Epigastric pain syndrome: must include 1 or 2 of the following, and at least 1 day a week: 1) Middle and epigastric pain (which interferes with daily activities); 2) Abdominal burning discomfort in the middle and upper abdomen (affecting daily activities). Routine examination, including gastroscopy, found no evidence of organic, systemic or metabolic disease that could explain the above symptoms.The symptoms appeared at least 6 months before diagnosis, and the above diagnostic criteria were met in the last 3 months. The diagnostic criteria for Rome IV IBS are: recurrent abdominal pain, with an average of at least 1 day per week in the last 3 months, accompanied by 2 or more of the following: 1) related to defecation; 2) accompanied by changes in the frequency of defecation; 3) accompanied by changes in fecal character (appearance).The symptoms appeared at least 6 months before diagnosis, and the above diagnostic criteria were met in the last 3 months. The diagnostic criteria for IVFC in Rome are: a. must contain two or more of the following: 1) more than 1/4 (25%) of the defecation experience difficulty; 2) More than 1/4 (25%) of the sense of defecation is dry ball stool or hard stool (Bristol fecal Traits Scale 1-2 type); 3) More than 1/4 (25%) of the defecation has a feeling of insufficiency; 4) More than 1/4 (25%) of defecation had anal rectum obstruction/blockage; 5) More than 1/4 (25%) of defecation needs manual assistance (such as finger assistance, pelvic floor support); 6) Spontaneous defecation less than 3 times per week; b. Rare occurrence of loose stool without laxatives;c. Does not meet the diagnostic criteria for irritable bowel syndrome.Symptoms appeared at least 6 months before diagnosis, and the above criteria were met in the last 3 months. IVFDr is defined as having at least 25% loose or watery stool without significant abdominal pain or distension.Symptoms appeared at least 6 months before diagnosis, and the above criteria were met in the last 3 months. 2. The ability to stop taking medications that may affect the evaluation of the results of the study, such as antibiotics, microecological preparations, laxatives, stool softeners or relaxants, and opioid painkillers; 3. Knowingly and voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: 1) Gastric cancer, peptic ulcer, intestinal cancer, dysplasia or other organic diseases of gastrointestinal tract were found by gastroenteroscopy in the past 1 year; 2) History of severe cardiopulmonary insufficiency, liver and kidney insufficiency, endocrine disorder, hematopoietic dysfunction; 3) History of abdominal surgery (except appendectomy and cesarean section); 4) Patients considered unsuitable for participating in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Positive rate of SIBO;

Countries

China

Contacts

Public ContactLing Liu

West China Hospital, Sichuan University

lingzipurple@163.com+86 189 8060 6772

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026