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The efficacy and safety of Bifidobacterium longum in relieving functional constipation, randomized, double-blind, placebo-parallel controlled clinical trial

The efficacy and safety of Bifidobacterium longum in relieving functional constipation, randomized, double-blind, placebo-parallel controlled clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100041925
Enrollment
Unknown
Registered
2021-01-10
Start date
2021-01-14
Completion date
Unknown
Last updated
2021-03-30

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

Conditions

constipation

Interventions

group1:Bifidobacterium longum FGDLZ8M1
group2:Bifidobacterium longum L6
group3: Bifidobacterium longum FGSZY6M4
group4:placebo

Sponsors

Affiliated Hospital of Jiangnan University (Wuxi Third People's Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for Rome IV constipation; (2) Between the ages of 0 and 100, the ratio of male to female is about 1:1; (3) BMI 18.5-29.9kg/m2; (4) The fecal state conforms to type 1-4 in The Stool Shape Classification Table (BSFS); (5) The Cleveland Clinical Constipation Score (CCCS) was evaluated at 8 to 15 points; (6) Good compliance and compliance during clinical trials; (7) The subject or guardian has signed the informed consent; (8) Patients filled in written informed consent form, questionnaire on basic information, questionnaire on dietary structure and living conditions, and promised to cooperate with the study during the whole experiment period.

Exclusion criteria

Exclusion criteria: (1) Having a chronic disease of the gastrointestinal tract, nervous system, cardiovascular, endocrine, renal or other conditions that may affect intestinal motility Disease; (2) Had undergone major abdominal surgery, especially gastrointestinal surgery; (3) The use of drugs related to digestive tract diseases within two weeks, such as anti-spasmodic drugs, laxatives, anti-diarrhea drugs and other drugs that have an impact on intestinal peristalsis; (4) Moderate or severe anorectal problems; (5) Allergic or lactose intolerant to the ingredients of experimental probiotics products; (6) Take probiotics, prebiotics, synbiotics, cellulose supplements or laxatives regularly; (7) Use of antibiotics within four weeks of the start of the study; (8) Take high dietary fiber (>18 g/day); (9) High level of anxiety or depression (hospital Anxiety and Depression Scale (HADS) assessment > 11 points), alcohol and drug abuse; (10) Women who are pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Stool frequency;Stool consistency;Gut symptoms;Bloating;PAC-SYM global score;PAC-QoL global score;Cleveland Clinic Constipation Score (CCCS);Anxiety and depression;Immune system disorders;Gastrointestinal disorders;Metabolism and nutrition disorders;

Countries

China

Contacts

Public Contactqixiao zhai

School of Food Science and Technology, Jiangnan University

zhaiqixiao@sina.com+86 15961760920

Outcome results

None listed

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