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A prospective randomized controlled study on intestinal function after anterograde probiotic enema and reinsertion in ileostomy

A prospective randomized controlled study on intestinal function after anterograde probiotic enema and reinsertion in ileostomy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108771
Enrollment
Unknown
Registered
2025-09-04
Start date
2025-09-06
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Recovery of intestinal function

Interventions

The experimental group was treated with anterograde probiotic enema:Before the operation, receive anterograde probiotic enema (such as Bifidobacterium triplex Live Bacteria enteric-coated Capsules 210
each gram contains Bifidobacterium longum >= 1.0*10^6 CFU, Lactobacillus acidophilus >= 1.0*10^6 CFU, Enterococcus faecalis >= 1.0*10^6 CFU, once a day) (once a day for 3 consecutive days). Assist the
The control group was treated with oral probiotics (Bifidobacterium trivalent live bacteria enteric-coated capsules 210mg*4 capsules twice a day) + conventional care (such as dietary guidance and stom

Sponsors

People's Hospital of Haiyan County
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1 For those diagnosed with ileostomy and meeting the indications for repositioning surgery, and who agree to undergo surgical treatment, there are no restrictions on their gender, race, or intraoperative anesthesia method. 2 Patients aged 18 to 80 years old who are willing to undergo surgery. 3 Postoperative vital signs are stable, and there is no severe infection or intestinal obstruction. 4 Those with complete preoperative intestinal preparation and no serious complications;

Exclusion criteria

Exclusion criteria: 1 Those who fail to cooperate with the treatment plan for medication and follow-up visits; 2 People with severe systemic diseases; 3 Those who are allergic to probiotics, have concurrent immune deficiencies or have relapsed intestinal malignant tumors. 4 Those with severe gastrointestinal diseases in the past 5 Those who must use drugs or treatments that have a significant impact on gastrointestinal function after the operation 6 Those who have severe bleeding or organ damage during the operation.

Design outcomes

Primary

MeasureTime frame
The earliest time when intestinal rumbling sounds appeared in postoperative patients;Postoperative anal exhaust time;Postoperative defecation time;

Secondary

MeasureTime frame
Abdominal distension score (VAS method;Diarrhea Severity Score (DSS);Incidence of complications;Days of hospital stay;

Countries

China

Contacts

Public ContactZhang Wangping

People's Hospital of Haiyan County

zwp72724@163.com+86 137 5731 7333

Outcome results

None listed

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