Effect of probiotics in improving constipation in the elderly

Effect of probiotics and their synbiotic combinations in improving constipation in the elderly

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300077583

Enrollment

Unknown

Registered

2023-11-13

Start date

2023-11-13

Completion date

Unknown

Last updated

2023-11-21

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

Conditions

Constipation in the elderly

Interventions

placebo group:placebo

test group:probiotics

Eligibility

Sex/Gender

All

Age

60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age = 60 years; 2. BMI 18.5-34.9 Kg/m2; 3. Whole bowel transit time = 59h (length of time the blue cake is out of the body); 4. Meet the Rome IV diagnostic criteria for constipation; ? Must include 2 or more of the following. a. More than 1/4 (25%) of bowel movements are laboured. b. More than 1/4 (25%) of the bowel movements are dry balls or hard stools (Bristol Stool Trait Scale type 1-2) c. More than 1/4 (25%) have a feeling of incomplete bowel movement d. 1/4 (25%) or more have a sense of anorectal obstruction/blockage with bowel movements e. More than 1/4 (25%) need manual assistance for defecation (e.g. finger-assisted defecation, pelvic floor support) f. Spontaneous bowel movement (SBM) less than 3 times per week. ? Rarely have loose stools when laxatives are not used. ?Symptoms have been present for at least 6 months prior to diagnosis, and the above diagnostic criteria have been met in the last 3 months. 5. Participate in this trial voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. suffering from serious gastrointestinal diseases such as colorectal cancer, acute enteritis, ulcerative colitis, etc; 2. have a history of major surgery of the digestive system (e.g. gastrointestinal resection, gastrointestinal suture, etc.) 3. severe cerebrovascular, neurological, endocrine/metabolic (e.g. diabetes mellitus, etc.) diseases; 4. those with severe hypertension, severe anaemia, excessive smoking and frequent alcohol abuse; 5. consume probiotic products regularly; 6. participation in other clinical studies within 1 month and those who, in the opinion of the investigator, are not suitable to participate in the trial.

Design outcomes

Primary

Measure	Time frame
Whole bowel transit time;Total Constipation Symptom Score for Constipated Patients;	—

Secondary

Measure	Time frame
Bristol Total Stool Trait Score;Quality of Survival Scale for Constipated Patients;Cleveland Constipation Score;Intestinal metabolites;gut flora;Inflammatory cytokines;haematological metabolomics;	—

Countries

China

Contacts

Public ContactJingjing He

China Agricultural University

hejingjing_89@163.com+86 151 2009 2404

Outcome results

None listed

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