Skip to content

Clinical effect of Live Combined Bacillus Subtilis with Enterococcus Faecium Enteric-coated Capsules and lactulose for treating functional constipation

Clinical effect of Live Combined Bacillus Subtilis with Enterococcus Faecium Enteric-coated Capsules and lactulose for treating functional constipation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002050
Enrollment
Unknown
Registered
2012-03-28
Start date
2010-11-22
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

function constipation

Interventions

Control group:Lactulose, the initial dose of 30 ~ 60ml / day, Taking a maintenance dose of 30ml / day, divided 1 or 2 times daily
treatment time: 2 weeks
Treatment group:Lactulose, the initial dose of 30 - 60ml / day, Taking a maintenance dose of 30ml / day, divided 1 or 2 times daily
Live Combined Bacillus Subtilis with Enterococcus Faecium Enteric-coated capsules, oral, Tid. Treatment time of 4 weeks with follow-up to consolidate the curative effect

Sponsors

The Military General Hospital of Beijing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Male or female who's age between 16 and 75, including patient in hospital or outpatient; 2) Match functional constipation which diagnosed by Rome III Standard criteria; 3) Have done a colonoscopy or barium enema during the past 1-2 years to rule out intestinal organic disease; 4) Without abnormity checked by fecal analysis and occult blood test past 1 month; 5) Willingness to follow the protocol requirement as evidenced by written, informed consent.

Exclusion criteria

Exclusion criteria: 1) Pregnancy or women in preparation for pregnancy or lactating women; 2) Disfunction of Heart, liver, renal, or diabetes; 3) Drugs affecting gastrointestinal motility / sensory function in the experiment can not be disabled: prokinetic drugs, erythromycin antibiotics, laxatives, antidiarrheal agents, narcotic analgesic agents; 4) Except the secondary constipation. Secondary constipation gastrointestinal tract diseases involving systemic organic diseases of the digestive tract, drug-induced constipation; 5) Exclude a simple outlet obstruction constipation; 6) Exclude patients who's Bristol stool typing 5, 6 and 7; 7) There are organic abnormalities of the gastrointestinal tract affect gastrointestinal function or evidence of disease. Include the following: History of gastrointestinal surgery (excluding appendectomy, intestinal benign polyp ablation resection, but surgery must be implemented before January there is no legacy complications); the history of organic gastrointestinal disease, such as intestinal diverticulitis, inflammatory bowel disease (IBD), intestinal tumors; The researchers believe that the diseases or conditions that affect gastrointestinal function; 8) Taking other drugs Within one month which will affect the test or someone can not understand or can not be completed the trial; 9) No legal capacity; 10) Take part in other clinical experiment at the same time; 11) There are other factors that may affect the test results, or unfit for trial according to the investigators judgment; 12) Allergic reaction to any drug.

Design outcomes

Primary

MeasureTime frame
Stool consistency;Stool Frequency;Difficuty in defecation;

Secondary

MeasureTime frame
abdominal pain, abdominal distention and borborygm;

Countries

China

Contacts

Public ContactShirong Li
lishirong@yahoo.cn+86 010 66721299

Outcome results

None listed

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