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A randomized, double-blind, controlled trial on the effects of multiple probiotics and their metabolites on irritable bowel syndrome

A randomized, double-blind, controlled trial on the effects of multiple probiotics and their metabolites on irritable bowel syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054376
Enrollment
Unknown
Registered
2021-12-16
Start date
2022-01-21
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

Irritable bowel syndrome

Interventions

Experimental group1:Oral compound probiotics for 1 month
Experimental group2:Oral compound probiotic metabolites
Control group1:Oral placebo for 1 month in the compound probiotic group
Experimental group3:Oral Bifidobacterium infantis BX-01 for 1 month
Experimental group4:Oral bifidobacterium infantis BX-01metabolites
Control group2:Oral placebo for Bifidobacterium infantis BX-01 group for 1 month

Sponsors

Inner Mongolia People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Gender is not limited, aged 18 to 70 years; 2. No abnormal results of intestinal examination (colonoscopy or barium meal angiography); 3. Symptoms have been present for at least 6 months before diagnosis, and the past 3 months meet the following diagnosis: (1) Abnormal defecation frequency (defecation > 3 times per day or < 3 times per week); (2) Mucus stool; (3) Abnormal feces (blocky, hard or watery stools); (4) Flatulence or abdominal distention; (5) Abnormal excretion of feces (labor, urgency, and incomplete defecation).

Exclusion criteria

Exclusion criteria: 1. History and family history of colon cancer, celiac disease and inflammatory bowel disease; 2. Subjects who have major mental illnesses, have difficulty controlling their actions, and cannot cooperate; 3. Those who are trying to conceive recently (including men and women), pregnant or breastfeeding women; 4. Those who are allergic to samples or ingredients; 5. Have taken antibiotics, probiotics and probiotics-related preparations within the past 2 weeks; 6. Those who have taken anti-anxiety, anti-depression and other psychotropic drugs in the past 1 month; 7. Those who need to take long-term medication to improve constipation or diarrhea; 8. Those who have been diagnosed with myocardial infarction, cerebral infarction, malignant tumor and other serious diseases that researchers think are not suitable for enrollment; 9. Subjects who are illiterate, unable to understand informed consent, and unable to sign the informed consent form by themselves.

Design outcomes

Primary

MeasureTime frame
Clinical symptoms;Intestinal mucosal barrier function;Intestinal flora;Inflammatory factor;Metabonomics;

Countries

China

Contacts

Public ContactGuo Ruifang

Inner Mongolia People's Hospital

grf_6872@163.com+86 180 4719 2249

Outcome results

None listed

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