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Effect of probiotic chewable tablets on regulating intestinal flora and improving constipation and diarrhea

Effect of probiotic chewable tablets on regulating intestinal flora and improving constipation and diarrhea

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052855
Enrollment
Unknown
Registered
2021-11-06
Start date
2021-11-18
Completion date
Unknown
Last updated
2022-08-23

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

Conditions

Constipation and diarrhea

Interventions

Probiotic group:2 chewable probiotics tablets per day (1 x 10^10)
Control group:Maltodextrin chewable tablets

Sponsors

Affiliated Hospital of Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Met the Roman IV criteria for functional constipation formulated by the American Gastroenterological Society (AGA) and officially released in 2016: (1) Those who met 2 or more of the following: 1) Laborious defecation (at least 1 in every 4 defecations); 2) Defecation is block or hard defecation (at least 1 defecation every 4 times); 3) There is a sense of exhaustion (at least 1 in every 4 defecation); 4) There is a sense of anal rectum obstruction or obstruction (at least 1 in every 4 defecation); 5) Artificial methods are needed to assist (at least 1 in every 4 defecation); 6) Poop less than 3 times a week; (2) There is almost no loose stool without laxative; (3) Insufficient basis for diagnosis of irritable bowel syndrome; 3. Diagnostic criteria for diarrhea :(1) stool frequency more than 3 times/day; (2) stool volume is more than 200 g/day, and water content is more than 85% of the total stool volume; 4. Those who voluntarily participate in the experiment and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Abdominal and/or intestinal surgery, except appendectomy, cholecystectomy, and non-surgical treatment of hemorrhoids; 2. Rectal prolapse and/or grade 3-4 internal hemorrhoids diagnosed according to AGA diagnostic criteria; 3. Drugs affecting intestinal motility were used, such as calcium antagonists, nitrates, and muscarinic drugs; 4. High dose stimulant laxatives (3 times a week) in the past 5 years; 5. Abdominal pain was rated as grade 5 on the visual analog scale from 0 to 10; 6. Patients with intestinal obstruction.

Design outcomes

Primary

MeasureTime frame
Blood routine examination;Routine urine test;Renal function;Liver function;Chest X-ray;

Countries

China

Contacts

Public ContactYang Ju

Affiliated Hospital of Jiangnan University

yangju0909@163.com+86 19137851605

Outcome results

None listed

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