Skip to content

The value of fecal calprotectin in the detection of patients with chronic organic diarrhea: a multiple center, prospective design and cross-section study

The value of fecal calprotectin in the detection of patients with chronic organic diarrhea: a multiple center, prospective design and cross-section study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300070117
Enrollment
Unknown
Registered
2023-04-03
Start date
2023-04-03
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

chronic diarrhea

Interventions

Gold Standard:The disease to be diagnosed in this study is the organic/functional cause of chronic diarrhea. Therefore, the diagnosis of organic diarrhea is determined by symptom + history + colonosco
Index test:1) fecal calcaretin concentration
2) Serological indexes of mucosal injury: 1. Diamine oxidase
2. Lactic acid
2. 3. Bacterial endotoxin and 4. Serum Zonulin protein.

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Subjects with chronic diarrhea: 1) Male and female, =18 years old; 2) Duration of diarrhea =3 months, accompanied by stool frequency =2 times/day, or the stool character is mushy/watery (Bristol stools type 6, 7); 3) To undergo colonoscopy/pathological biopsy; 4) Agree to participate in this clinical study and sign informed consent. Healthy control: 1) Male and female, =18 years old; Gender, age, and BMI were matched with the case group; 2) No symptoms of diarrhea, good health condition, no current digestive disease, and no history of severe digestive disease or other serious diseases; 3) Agree to participate in the clinical study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Ascites, abdominal mass, or history of abdominal/pelvic surgery, such as biliopancreatic surgery (patients who have received appendectomy or cesarean section without intestinal complications such as intestinal obstruction; Patients who had received endoscopic treatment for intestinal polyps were not excluded); 2) A history of the following diseases: diffuse small bowel disease, diabetic phytoneuropathy, hyperthyroid-related diarrhea, carcinoid syndrome, pheochromocytoma, Addison's disease, serious systemic diseases (immune system diseases are not excluded); 3) Diarrhea is associated with long-term or recent use of laxatives; 4) Known or suspected gastrointestinal obstruction, stenosis, fistula or active bleeding, and other conditions that cannot be colonoscopically detected; 5) Pregnant or lactating women; 6) Patients with mental illness (unable to cooperate with research or unable to sign informed consent); 7) Subjects who have participated in or are participating in other clinical trials within three months; 8) The researcher considers that there are any other influencing factors that may not be appropriate for the subject to participate in the study.

Design outcomes

Primary

MeasureTime frame
The results of the colonoscopy;Fecal calprotectin concentration;Efficacy of fecal calprotectin testing in the diagnosis of chronic organic diarrhea;

Secondary

MeasureTime frame
Symptoms associated with diarrhea in patients;Intestinal biopsy results;Intestinal permeability;The sensitivity and specificity of fecal calprotectin in the detection of different types of organic chronic diarrhea (IBD active or inactive stage, tumor, intestinal tuberculosis, and microscopic mucosal inflammation);Sensitivity and specificity of fecal calprotectin detection in different types of functional chronic diarrhea (IBS-D, FDr, etc.);To explore the sensitivity and specificity of calprotectin combined with colonoscopy in the detection of microscopic mucosal inflammation;To explore the sensitivity and specificity of calprotectin in the detection of chronic diarrhea;Preliminary exploration of the sensitivity and specificity of calprotectin combined with mucosal injury serologic indicators or mucosal injury serological indicators alone in the detection of organic diarrhea;

Countries

China

Contacts

Public ContactXiaohua Hou

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

houxh@hust.edu.cn13035143646

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 22, 2026