Effects of Vitamin D on Gut Microbiota, Intestinal Barrier in IBS-D Patients

Diarrhea-predominant Irritable Bowel Syndrome Clinical Trial

Official title:

Effects of Vitamin D on Gut Microbiota, Intestinal Barrier in Patients With Diarrhea-predominant Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05593367
• Other study ID #: 2022014
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: June 2023

Study information

• Verified date: October 2022
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: Fei Dai
• Phone: 13772151298
• Email: daifei68[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disease. Evidence suggests that the concentration of serum VD is decreased in IBS patients, particularly in IBS-D. After giving a supplementation of VD, some symptoms of these patients were relieved to a certain degree. However, the specific mechanism still remains unclear.

Description:

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disease, which is due to the gut microbiota disturbances, intestinal mucosal barrier dysfunction, and brain-gut axis dysfunction. Vitamin D (VD), a fat-soluble vitamin, has been found to be associated with gut microbiota, intestinal mucosal barrier and NLRP3 in inflammatory bowel disease, nonalcoholic fatty liver disease and other diseases. The concentration of serum VD is decreased in IBS patients, particularly in IBS-D. And the symptoms of IBS patients seems to be connected with the level of serum VD. After giving a supplementation of VD, some symptoms of these patients were relieved to a certain degree. However, the specific mechanism still remains unclear.We designed a study to figure out the effects of serum VD on gut microbiota, intestinal mucosal barrier and in patients with IBS-D.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ?IBS-D patients meeting the Roman IV diagnostic criteria: recurrent abdominal pain, averaging at least 1 day per week in the last 3 months, with 2 or more of the following: associated with defecation, accompanied by changes in defecation frequency, accompanied by changes in fecal properties or appearance. (Symptoms have been present for at least 6 months before diagnosis, and meet the above diagnostic criteria in the last 3 months; >1/4 (25%) stools were Bristol Stool Scale type 6 or 7, and <1/4 (25%) stools were Bristol Stool Scale type 1 or 2); ? The age ranged from 18 to 65.

Exclusion Criteria:

• ? History of other gastrointestinal diseases, such as inflammatory bowel disease, infection, cancer, abdominal radiation or surgery, hepatobiliary and pancreatic diseases; ? Taking vitamin D drugs, calcium, contraceptives, glucocorticoids, probiotics, antibiotics, antidepressants, etc.; ? Pregnancy and lactation; ? Diabetes mellitus, thyroid disease, osteoporosis, etc.; ? Complicated with serious heart, liver, lung, kidney, blood, serious mental diseases and other systemic diseases; (6) Boston Intestinal Preparation Scale score <6; The cecum was not detected by endoscopy. ? Unwilling to participate or unable to give informed consent.

Related Conditions & MeSH terms

• Diarrhea
• Diarrhea-predominant Irritable Bowel Syndrome
• Irritable Bowel Syndrome
• Syndrome

Locations

Country	Name	City	State
China	The second affiliated hospital of xi'an jiaotong university	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gut microbiota	Detect the fecal microbiome by 16S rRNA gene sequencing.	1 week before colonoscopy
Primary	intestinal barrier	Detect the expressions of Z0-1, occludin in intestinal mucosa	During the colonoscopy