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

Sponsor
Second Affiliated Hospital of Xi'an Jiaotong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05593367
Collaborator
(none)
80
1
15.9
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Effects of Vitamin D on Gut Microbiota, Intestinal Barrier in Patients With Diarrhea-predominant Irritable Bowel Syndrome
    Actual Study Start Date :
    Feb 1, 2022
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Jun 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. gut microbiota [1 week before colonoscopy]

      Detect the fecal microbiome by 16S rRNA gene sequencing.

    2. intestinal barrier [During the colonoscopy]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • 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.
    Exclusion Criteria:
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The second affiliated hospital of xi'an jiaotong university Xi'an Shaanxi China 710004

    Sponsors and Collaborators

    • Second Affiliated Hospital of Xi'an Jiaotong University

    Investigators

    • Principal Investigator: Fei Dai, Second Affiliated Hospital of Xi'an Jiaotong University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital of Xi'an Jiaotong University
    ClinicalTrials.gov Identifier:
    NCT05593367
    Other Study ID Numbers:
    • 2022014
    First Posted:
    Oct 25, 2022
    Last Update Posted:
    Oct 25, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Second Affiliated Hospital of Xi'an Jiaotong University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 25, 2022