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A randomized, double-blind, placebo-controlled trial of Bifidobacterium bifidum CCFM16 for the relief of chronic constipation

Study on the effect and mechanism of probiotics on patients with constipation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046957
Enrollment
Unknown
Registered
2021-06-02
Start date
2020-06-26
Completion date
Unknown
Last updated
2022-01-18

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

Conditions

Chronic constipation

Interventions

Placebo group:Placebo
Bifidobacterium bifidum CCFM16 group:2 billion Bifidobacterium bifidum CCFM16

Sponsors

The Peoples' Hospital of Tinghu District of Yancheng City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnositc criteria of Rome IV; 2. Aged 18 to 80 years; 3. Have not taken with probiotics (such as lactic acid bacteria, bifidobacteria, etc.) yogurt, beverages and etc. In the past two months; Adhere to the requirements of taking probiotic productions for 2 months; Cooperate with the survey And the collection of blood samples, feces and other biological samples; 4. Volunteers who sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Constipation due to other diseases, functional defecation disorders and medications, such as: Parkinson's syndrome, anterior rectal distention pelvic floor spasm, megacolon, hypothyroidism and patients on long-term pain medication. 2. Those who cannot comply with observation due to alcoholism, substance abuse or psychiatric factors. 3. Patients with chronic laxative abuse. 4. Patients who are estimated to have poor compliance and poor follow-up possibilities 5. Recent (4 weeks) consumption of probiotic products or long-term consumption of yogurt or probiotic drinks. 6. Recent (4 weeks) or long-term use of antibiotics. 7. Allergy or intolerance to the ingredients of the tested probiotic product. 8. Pregnant or breastfeeding women, or women who plan to become pregnant or breastfeed during the study period.

Design outcomes

Primary

MeasureTime frame
Fecal flora;SCFAs in feces;Serological indicators;Blood routine test;Routine uninalysis;High sensitive C reactive protein;Blood lipid;Liver function;

Secondary

MeasureTime frame
Height;Weight;

Countries

China

Contacts

Public ContactWang Gang

Jiangnan University

wanggang@jiangnan.edu.cn+86 15852818722

Outcome results

None listed

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