Health TrialsbyHealthPanel

Autologous Probiotics in Patients With Defunctioning Ileostomy Following LAR for Rectal Cancer

ConditionsRectal CancerGut MicrobiomesAutologous Probiotic TransplantationDefunctioning Ileostomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University Cancer Hospital & Institute

About this trial

Rectal cancer patients who received low anterior resection combined with ileostomy may effectively reduce the probability of anastomotic leakage after surgery. However, due to the long-term semi-abandoned state of the distal colon, the probability of bowel dysfunction after ileostomy closure is very high. The incidence of low anterior resection syndrome (LARS) exceeds 70%, which is twice that of those who did not receive a preventive stoma. The main reasons include postoperative anatomical structure alteration, nerve damage, pathological changes of the colorectal mucosa, and gut microbiota variation, etc. The application of probiotics can significantly improve the bowel function of these patients. In this study, in order to enhance the colonization effect of probiotics, autologous probiotics will be applied to treat patients with defunctioning ileostomy. The primary outcome is the occurrence of major LARS after 6 months of the treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Autologous Probiotics

    Dietary supplement

    Patients with defunctioning ileostomy following low anterior resection for rectal cancer, receive autologous probiotics (lactobacillus and bifidobacterium) after ileostomy closure. All patients will take a 100-day supply of high-activity autologous probiotic enteric-coated capsules (100 lactobacillus and 100 bifidobacterium enteric-coated capsules, 1 capsule per day, with each capsule containing a CFU activity of no less than 100 billion)

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Autologous Probiotics TransplantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with major low anterior resection syndrome score (LARS score)

Time frame
at the time of 6 months since the start of treatment

Secondary outcomes

1

Quality of life impairment assessed by Short Form 36 (SF-36)

Quality of life will be assessed by Short Form 36 (SF-36) health questionnaire.

Time frame
at the time of 1, 3, 6, 12 months since the start of treatment
2

Number of participants with major low anterior resection syndrome score (LARS score)

Time frame
at the time of1, 3, 6, 12months since the start of treatment
3

Bowel function impairment

Bowel function will be assessed by Memorial Sloan Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI). Stool frequency will be recorded in the day and night.

Time frame
at the time of 1, 3, 6, 12 months since the start of treatment
4

Fecal continence impairment

Fecal incontinence will be assessed by Wexner incontinence scale (WIS).

Time frame
at the time of 6, 12 months since the start of treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Cancer Hospital & Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: