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

NCT05593367 | Unknown

• 1 other identifier: 2022014
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diarrhea-predominant Irritable Bowel Syndrome

Keywords

IBS-D; Vitamin D; Gut microbiota; Intestinal barrier;

Outcome Measures

Primary Outcomes (2)

• gut microbiota

  Detect the fecal microbiome by 16S rRNA gene sequencing.

  1 week before colonoscopy

• intestinal barrier

  Detect the expressions of Z0-1, occludin in intestinal mucosa

  During the colonoscopy

Study Arms (2)

VD-， VD deficiency group

The IBS-D patients whose serum 25(OH)D level was\<20ng/ml

VD+， VD normal group

The IBS-D patients whose serum 25(OH)D level was ≥20ng/ml

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IBS-D Patients who meet the above criteria

You may qualify if:

• ①IBS-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); ② The age ranged from 18 to 65.

You may not qualify if:

• ① History of other gastrointestinal diseases, such as inflammatory bowel disease, infection, cancer, abdominal radiation or surgery, hepatobiliary and pancreatic diseases; ② Taking vitamin D drugs, calcium, contraceptives, glucocorticoids, probiotics, antibiotics, antidepressants, etc.; ③ Pregnancy and lactation; ④ Diabetes mellitus, thyroid disease, osteoporosis, etc.; ⑤ 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. ⑦ Unwilling to participate or unable to give informed consent.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The second affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, 710004, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal Specimen, Serum Specimen；Intestinal Mucosa Specimen

Study Officials

• Fei Dai

  Second Affiliated Hospital of Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Dai

CONTACT

13772151298; daifei68@hotmail.com

Yue Zhang

CONTACT

13572208372; zhangyue_zyzy@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 25, 2022
• Study Start: February 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

CN (1)