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Efficacy and safety of probiotics formula in improving diarrheal Irritable Bowel Syndrome.

Efficacy and safety of probiotics formula in improving diarrheal Irritable Bowel Syndrome.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085485
Enrollment
Unknown
Registered
2024-06-07
Start date
2024-06-07
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

diarrheal Irritable Bowel Syndrome

Interventions

Test group:complex-probiotic-preparation, take 4 capsules once a day for 4 weeks.
Control group:Placebo capsule, take 4 capsules once a day for 4 weeks.

Sponsors

Army Medical Center(Daping Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: ?Male or female, age 18-70 years old. ?The patient was diagnosed with diarrheal Irritable Bowel Syndrome(according to Roman criteria V), and the frequency of defecation was greater than 3 times/day, and the course of the disease was greater than 6 months. ? No mental illness, with normal communication ability. ? Sign informed consent and agree to participate in this study.

Exclusion criteria

Exclusion criteria: ? Complicated with other serious diseases, such as respiratory failure, heart failure and severe immune deficiency, with surgical indications or previous colon surgery. ? Combined with other diseases that affect the intestinal microbiota, such as metabolic syndrome and autoimmune diseases. ? Women in pregnancy, pregnancy and lactation. ? Use of antibiotics or probiotics within 1 week before enrollment. ? A history of severe allergies. ? Other clinical researchers in the process of enrollment or within 4 weeks before enrollment. ? Patients with poor compliance and difficulty in completing follow-up. ? Other reasons that the investigator thinks are not suitable for enrollment or subjects withdraw from the trial due to their own reasons.

Design outcomes

Primary

MeasureTime frame
IBS symptom severity scale,IBS-SSS;

Secondary

MeasureTime frame
Gastrointestinal Symptoms Rating Scales,GSRS;Bristol stool form scale,BSS;face rating scale,FRS;intestinal flora;IBS symptom severity scale,IBS-SSS;

Countries

China

Contacts

Public ContactYanling Wei

Army Medical Center(Daping Hospital)

lingzi016@126.com+86 153 1035 4666

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026