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

NCT ID: NCT05593367

Last Updated: 2022-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diarrhea-predominant Irritable Bowel Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

VD-, VD deficiency group

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

No interventions assigned to this group

VD+, VD normal group

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fei Dai

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Xi'an Jiaotong University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The second affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fei Dai

Role: CONTACT

13772151298

Yue Zhang

Role: CONTACT

13572208372

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fei Dai, MD

Role: primary

13772151298

Yue Zhang

Role: backup

13572208372

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.